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A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT00556712
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: erlotinib [Tarceva]
Drug: Placebo
Enrollment 889
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Erlotinib, 150 Milligrams Per Day (mg/Day)
Hide Arm/Group Description Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were randomized to receive a placebo, orally (PO) as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Period Title: Overall Study
Started 451 438
Completed 0 [1] 0 [1]
Not Completed 451 438
Reason Not Completed
Adverse Event             7             19
Death             5             10
Progressive Disease             383             320
Protocol Violation             3             2
Refused Treatment             17             16
Failure to Return             2             3
Not Specified             2             2
Ongoing at Data Cutoff             32             66
[1]
Data cutoff date: 17 May 2008
Arm/Group Title Placebo Erlotinib, 150 mg/Day Total
Hide Arm/Group Description Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. Total of all reporting groups
Overall Number of Baseline Participants 451 438 889
Hide Baseline Analysis Population Description
Full analysis set (FAS): all randomized participants presented according to the therapy that they were randomized to receive
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 451 participants 438 participants 889 participants
59.7  (9.39) 59.8  (9.52) 59.8  (9.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 451 participants 438 participants 889 participants
Female
113
  25.1%
117
  26.7%
230
  25.9%
Male
338
  74.9%
321
  73.3%
659
  74.1%
1.Primary Outcome
Title Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)
Hide Description Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time Frame Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; participants with PD prior to randomization were excluded from analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 447 437
Measure Type: Number
Unit of Measure: percentage of participants
89.5 79.9
2.Primary Outcome
Title PFS in All Participants (Data Cutoff 17 May 2008)
Hide Description The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; participants with PD prior to randomization were excluded from analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 447 437
Median (95% Confidence Interval)
Unit of Measure: weeks
11.1
(8.1 to 11.7)
12.3
(12.0 to 13.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.62 to 0.82
Estimation Comments [Not Specified]
3.Primary Outcome
Title Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)
Hide Description PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; participants with PD prior to randomization were excluded from analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 447 437
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.0
(12.0 to 19.0)
25.0
(21.0 to 29.0)
4.Primary Outcome
Title Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)
Hide Description PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with EGFR IHC positive tumors were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 311 307
Measure Type: Number
Unit of Measure: percentage of participants
89.4 79.5
5.Primary Outcome
Title PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)
Hide Description The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS;only participants with EGFR IHC positive tumors were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 311 307
Median (95% Confidence Interval)
Unit of Measure: weeks
11.1
(7.1 to 11.7)
12.3
(12.0 to 17.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.58 to 0.82
Estimation Comments [Not Specified]
6.Primary Outcome
Title Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)
Hide Description PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with EGFR IHC positive tumors were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 311 307
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16.0
(12.0 to 21.0)
27.0
(22.0 to 32.0)
7.Secondary Outcome
Title Percentage of All Participants Who Died (Data Cutoff 12 January 2012)
Hide Description [Not Specified]
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months).
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 451 438
Measure Type: Number
Unit of Measure: percentage of participants
87.1 82.0
8.Secondary Outcome
Title Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)
Hide Description OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 451 438
Median (95% Confidence Interval)
Unit of Measure: months
11.0
(9.9 to 12.0)
12.4
(10.6 to 13.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0097
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.72 to 0.96
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)
Hide Description OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 451 438
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
45.0
(41.0 to 50.0)
50.0
(45.0 to 55.0)
10.Secondary Outcome
Title Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)
Hide Description [Not Specified]
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with EGFR IHC positive tumors were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 313 308
Measure Type: Number
Unit of Measure: percentage of participants
87.5 80.5
11.Secondary Outcome
Title OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)
Hide Description OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with EGFR IHC positive tumors were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 313 308
Median (95% Confidence Interval)
Unit of Measure: months
11.0
(9.7 to 12.8)
12.8
(11.1 to 14.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0050
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.66 to 0.93
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012)
Hide Description OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 313 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
47.0
(41.0 to 52.0)
52.0
(47.0 to 58.0)
13.Secondary Outcome
Title Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008)
Hide Description PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with EGFR IHC negative tumors were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 59 62
Measure Type: Number
Unit of Measure: percentage of participants
89.8 77.4
14.Secondary Outcome
Title PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)
Hide Description The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with EGFR IHC negative tumors were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 59 62
Median (95% Confidence Interval)
Unit of Measure: weeks
9.0
(6.4 to 12.0)
11.0
(6.6 to 13.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1768
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.51 to 1.14
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)
Hide Description PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with EGFR IHC negative tumors were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 59 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.0
(2.0 to 20.0)
22.0
(11.0 to 34.0)
16.Secondary Outcome
Title Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008)
Hide Description [Not Specified]
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with EGFR IHC negative tumors were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 59 62
Measure Type: Number
Unit of Measure: percentage of participants
50.8 41.9
17.Secondary Outcome
Title OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)
Hide Description OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with EGFR IHC negative tumors were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 59 62
Median (95% Confidence Interval)
Unit of Measure: months
10.2
(7.4 to 11.2)
8.6 [1] 
(7.4 to NA)
[1]
The upper limit of the 95% CI could not be calculated due to the large number of censored events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4797
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.49 to 1.40
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008)
Hide Description OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with EGFR IHC negative tumors were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 59 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.0
(3.0 to 37.0)
42.0
(25.0 to 59.0)
19.Secondary Outcome
Title Time to Progression (Data Cutoff 17 May 2008)
Hide Description The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; participants with PD prior to randomization were excluded from analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 447 437
Median (95% Confidence Interval)
Unit of Measure: weeks
11.3
(8.1 to 11.9)
12.3
(12.0 to 14.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.61 to 0.82
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008)
Hide Description TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; participants with PD prior to randomization were excluded from analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 447 437
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.0
(11.0 to 19.0)
26.0
(21.0 to 30.0)
21.Secondary Outcome
Title Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008)
Hide Description BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 445 436
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.4
(3.5 to 7.9)
11.9
(9.0 to 15.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 6.53
Confidence Interval (2-Sided) 95%
2.7 to 10.3
Estimation Comments The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.
22.Secondary Outcome
Title Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008)
Hide Description For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis; and 7 and 17 participants were not assessed from the Placebo and Erlotinib, 150 mg/day groups, respectively.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 445 436
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR
0.7
(0.1 to 2.0)
0.9
(0.3 to 2.3)
PR
4.7
(2.9 to 7.1)
11.0
(8.2 to 14.3)
SD
45.4
(40.7 to 50.1)
48.6
(43.8 to 53.4)
PD
47.6
(42.9 to 52.4)
35.6
(31.1 to 40.2)
23.Secondary Outcome
Title Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008)
Hide Description Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 445 436
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.3
(0.5 to 2.9)
5.5
(3.6 to 8.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Upgrade Rates
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
1.6 to 6.7
Estimation Comments The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.
24.Secondary Outcome
Title Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008)
Hide Description For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 445 436
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
PR to CR
0.4
(0.1 to 1.6)
0.5
(0.1 to 1.6)
SD to PR
0.9
(0.2 to 2.3)
4.8
(3.0 to 7.3)
SD to CR
0.0
(0.0 to 0.8)
0.2
(0.0 to 1.3)
25.Secondary Outcome
Title Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008)
Hide Description Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 445 436
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CR Plus (+) PR + SD
50.8
(46.0 to 55.5)
60.6
(55.8 to 65.2)
CR + PR + SD >12 Weeks
27.4
(23.3 to 31.8)
40.8
(36.2 to 45.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments Analysis included CR + PR + SD rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Disease Control Rates
Estimated Value 9.8
Confidence Interval (2-Sided) 95%
3.1 to 16.4
Estimation Comments Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments Analysis included CR + PR + SD > 12 weeks rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Disease Control Rates
Estimated Value 13.4
Confidence Interval (2-Sided) 95%
7.1 to 19.7
Estimation Comments Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.
26.Secondary Outcome
Title Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008)
Hide Description LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; 56 and 48 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 395 390
Measure Type: Number
Unit of Measure: percentage of participants
44.1 47.7
27.Secondary Outcome
Title Time to Symptom Progression (Data Cutoff 17 May 2008)
Hide Description The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 395 390
Median (95% Confidence Interval)
Unit of Measure: weeks
17.6
(12.4 to 19.1)
18.3
(13.1 to 24.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3787
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.74 to 1.12
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008)
Hide Description LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame 6 months
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FAS
Arm/Group Title Placebo Erlotinib, 150 mg/Day
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Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 395 390
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
35.0
(27.0 to 42.0)
41.0
(34.0 to 47.0)
29.Secondary Outcome
Title Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008)
Hide Description The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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FAS; 59 and 49 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
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Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 392 389
Measure Type: Number
Unit of Measure: percentage of participants
43.1 50.9
30.Secondary Outcome
Title Time to Deterioration in TOI (Data Cutoff 17 May 2008)
Hide Description The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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FAS
Arm/Group Title Placebo Erlotinib, 150 mg/Day
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Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 392 389
Median (95% Confidence Interval)
Unit of Measure: weeks
18.9
(13.6 to 24.1)
18.1
(12.3 to 19.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5385
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.87 to 1.31
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008)
Hide Description TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame 6 months
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FAS
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 392 389
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41.0
(34.0 to 48.0)
39.0
(33.0 to 45.0)
32.Secondary Outcome
Title Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008)
Hide Description Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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FAS; 62 and 51 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively,
Arm/Group Title Placebo Erlotinib, 150 mg/Day
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Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 389 387
Measure Type: Number
Unit of Measure: percentage of participants
51.7 55.3
33.Secondary Outcome
Title Time to Deterioration in QoL (Data Cutoff 17 May 2008)
Hide Description The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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FAS
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 389 387
Median (95% Confidence Interval)
Unit of Measure: weeks
12.3
(11.9 to 17.9)
12.6
(12.1 to 18.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Erlotinib, 150 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6530
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.79 to 1.16
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008)
Hide Description Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology.
Time Frame 6 months
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FAS
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 389 387
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.0
(27.0 to 40.0)
32.0
(26.0 to 38.0)
35.Secondary Outcome
Title Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008)
Hide Description Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0="not at all" and 4="very much"). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0="Not at all" to 4="Very much"; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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FAS; n=number of participants assessed for the given parameter at the specified timepoint.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
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Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 397 392
Mean (Standard Deviation)
Unit of Measure: score on a scale
BL: Physical Well-Being (n=397,392) 20.85  (4.817) 20.96  (4.781)
BL: Social Well-Being (n=397,392) 20.84  (5.496) 20.98  (5.285)
BL: Emotional Well-Being (n=397,393) 16.92  (4.534) 16.77  (4.862)
BL: Functional Well-Being (n=397,393) 16.15  (5.488) 16.84  (5.514)
BL: FACT-L Subscale Score (n=397,391) 24.17  (4.892) 24.46  (4.697)
BL: Lung Cancer Subscale Score (n=397,391) 19.82  (4.188) 20.07  (4.240)
BL: Total FACT-General (FACT-G) Score (n=396,391) 74.68  (14.787) 75.52  (14.612)
BL: Trial Outcome Index (n=396,390) 56.83  (11.830) 57.90  (11.682)
BL: Total FACT-L Score (n=395,389) 98.85  (18.007) 100.02  (17.751)
Week 6: Physical Well-Being (n=274,304) 21.44  (5.117) 20.69  (5.180)
Week 6: Social Well-Being (n=274,303 20.62  (5.437) 21.43  (5.178)
Week 6: Emotional Well-Being (n=275,302) 16.53  (4.587) 17.17  (4.748)
Week 6: Functional Well-Being (n=275,302) 16.41  (5.234) 16.87  (5.614)
Week 6: FACT-L Subscale Score (n=275,300) 24.45  (5.231) 24.80  (5.000)
Week 6: Lung Cancer Subscale Score (n=275,300) 19.78  (4.463) 20.13  (4.336)
Week 6: Total FACT-G Score (n=274,300) 74.82  (14.380) 76.14  (15.132)
Week 6: Trial Outcome Index (n=274,299) 57.59  (12.292) 57.64  (12.482)
Week 6: Total FACT-L Score (n=274,297) 99.27  (17.857) 100.95  (18.360)
Week 12: Physical Well-Being (n=144,194) 21.93  (4.734) 20.78  (5.368)
Week 12: Social Well-Being (n=143,194) 20.38  (5.637) 20.04  (5.691)
Week 12: Emotional Well-Being (n=144,194) 17.21  (4.376) 16.85  (4.521)
Week 12: Functional Well-Being (n=144,196) 17.04  (5.770) 16.35  (5.745)
Week 12: FACT-L Subscale Score (n=144,196) 25.15  (4.735) 24.19  (5.323)
Week 12: Lung Cancer Subscale Score (n=144,196) 20.22  (4.015) 19.50  (4.600)
Week 12: Total FACT-G Score (n=144,192) 76.42  (14.889) 74.06  (15.754)
Week 12: Trial Outcome Index (n=144,194) 59.19  (12.129) 56.57  (13.276)
Week 12: Total FACT-L Score (n=144,192) 101.56  (17.824) 98.30  (19.337)
Week 18: Physical Well-Being (n=86,143) 21.60  (4.883) 21.40  (4.945)
Week 18: Social Well-Being (n=86,143) 21.08  (5.328) 19.94  (6.130)
Week 18: Emotional Well-Being (n=86,143) 17.33  (4.717) 17.14  (4.356)
Week 18: Functional Well-Being (n=86,143) 16.89  (5.289) 16.83  (5.553)
Week 18: FACT-L Subscale Score (n=86,143) 25.44  (4.645) 24.52  (5.344)
Week 18: Lung Cancer Subscale Score (n=86,143) 20.28  (4.003) 19.64  (4.635)
Week 18: Total FACT-G Score (n=86,143) 76.89  (14.385) 75.31  (16.648)
Week 18: Trial Outcome Index (n=86,143) 58.76  (11.492) 57.87  (12.803)
Week 18: Total FACT-L Score (n=86,143) 102.33  (17.502) 99.83  (20.558)
Week 24: Physical Well-Being (n=59,101) 21.78  (4.665) 21.21  (4.898)
Week 24: Social Well-Being (n=59,101) 20.79  (5.641) 20.49  (5.251)
Week 24: Emotional Well-Being (n=59,100) 16.86  (4.880) 16.54  (4.615)
Week 24: Functional Well-Being (n=59,100) 17.14  (6.062) 17.23  (5.300)
Week 24: FACT-L Subscale Score (n=59,101) 25.18  (5.126) 25.13  (5.245)
Week 24: Lung Cancer Subscale Score (n=59,101) 20.07  (4.246) 19.94  (4.487)
Week 24: Total FACT-G Score (n=59,99) 76.58  (16.091) 75.50  (15.754)
Week 24: Trial Outcome Index (n=59,100) 58.99  (11.837) 58.37  (12.686)
Week 24: Total FACT-L Score (n=59,99) 101.75  (19.347) 100.69  (19.831)
Week 30: Physical Well-Being (n=37,66) 21.74  (4.153) 21.77  (4.576)
Week 30: Social Well-Being (n=37,66) 20.50  (5.180) 20.74  (5.491)
Week 30: Emotional Well-Being (n=37,66) 16.37  (4.164) 17.23  (4.675)
Week 30: Functional Well-Being (n=37,66) 17.92  (5.082) 17.93  (5.510)
Week 30: FACT-L Subscale Score (n=37,66) 25.90  (3.484) 25.86  (4.817)
Week 30: Lung Cancer Subscale Score (n=37,66) 20.66  (3.073) 20.61  (4.393)
Week 30: Total FACT-G Score (n=37,66) 76.54  (11.915) 77.66  (15.078)
Week 30: Trial Outcome Index (n=37,66) 60.32  (9.753) 60.30  (11.876)
Week 30: Total FACT-L Score (n=37,66) 102.44  (14.063) 103.52  (18.367)
Week 36: Physical Well-Being (n=25,47) 21.60  (3.317) 22.26  (4.480)
Week 36: Social Well-Being (n=25,47) 20.02  (5.769) 20.15  (4.988)
Week 36: Emotional Well-Being (n=25,47) 17.31  (3.736) 17.54  (4.540)
Week 36: Fuctional Well-Being (n=25,47) 16.06  (4.287) 18.06  (5.720)
Week 36: FACT-L Subscale Score (n=25,47) 24.48  (4.089) 25.83  (5.305)
Week 36: Lung Cancer Subscale Score (n=25,47) 19.36  (3.893) 20.55  (4.463)
Week 36: Total FACT-G Score (n=25,47) 74.99  (11.066) 78.02  (15.688)
Week 36: Trial Outcome Index (n=25,47) 57.02  (9.426) 60.87  (11.963)
Week 36: Total FACT-L Score (n=25,47) 99.27  (13.672) 103.86  (19.244)
Week 42: Physical Well-Being (n=19,35) 21.76  (3.592) 22.19  (5.035)
Week 42: Social Well-Being (n=19,35) 18.45  (6.262) 20.40  (5.234)
Week 42: Emotional Well-Being (n=19,35) 16.95  (4.089) 17.43  (4.984)
Week 42: Functional Well-Being (n=19,35) 15.32  (3.902) 18.57  (5.500)
Week 42: FACT-L Subscale Score (n=19,35) 24.63  (4.448) 26.67  (5.357)
Week 42: Lung Cancer Subscale Score (n=19,35) 19.50  (4.092) 21.21  (4.607)
Week 42: FACT-G Score (n=19,35) 72.74  (12.406) 78.59  (16.316)
Week 42: Trial Outcome Index (n=19,35) 56.58  (9.562) 61.97  (12.622)
Week 42: FACT-L Score (n=19,35) 97.11  (14.951) 105.25  (20.385)
Week 48: Physical Well-Being (n=13,29) 21.38  (4.154) 23.23  (4.016)
Week 48: Social Well-Being (n=13,29) 17.23  (7.567) 20.24  (5.569)
Week 48: Emotional Well-Being (n=13,29) 18.69  (3.011) 17.59  (4.903)
Week 48: Functional Well-Being (n=13,29) 14.15  (2.672) 18.48  (4.501)
Week 48: FACT-L Subscale Score (n=12,29) 23.35  (3.647) 26.80  (5.591)
Week 48: Lung Cancer Subscale Score (n=12,29) 18.75  (3.646) 21.21  (4.967)
Week 48: FACT-G Score (n=12,29) 71.46  (12.069) 79.53  (14.672)
Week 48: Trial Outcome Index (n=12,29) 54.58  (9.140) 62.92  (11.105)
Week 48: FACT-L Score (n=12,29) 96.19  (14.394) 106.33  (18.701)
Week 60: Physical Well-Being (n=9,17) 22.67  (4.664) 23.65  (4.212)
Week 60: Social Well-Being (n=9,17) 17.78  (6.405) 21.31  (6.530)
Week 60: Emotional Well-Being (n=9,17) 16.78  (3.232) 19.12  (3.638)
Week 60: Functional Well-Being (n=9,17) 15.11  (3.408) 18.65  (6.828)
Week 60: FACT-L Subscale Score (n=9,17) 23.43  (5.010) 25.99  (6.844)
Week 60: Lung Cancer Subscale Score (n=9,17) 17.89  (3.919) 20.47  (5.959)
Week 60: Total FACT-G Score (n=9,17) 72.34  (11.607) 82.73  (17.803)
Week 60: Trial Outcome Index (n=9,17) 55.67  (9.695) 62.76  (14.316)
Week 60: Total FACT-L Score (n=9,17) 95.77  (15.703) 108.71  (23.069)
Week 72: Physical Well-Being (n=6,8) 22.17  (4.997) 23.25  (4.097)
Week 72: Social Well-Being (n=6,8) 19.00  (7.251) 21.44  (5.852)
Week 72: Emotional Well-Being (n=6,8) 17.17  (2.401) 18.25  (5.007)
Week 72: Functional Well-Being (n=6,8) 15.22  (4.457) 16.50  (5.855)
Week 72: FACT-L Subscale Score (n=6,8) 21.23  (5.154) 26.48  (6.185)
Week 72: Lung Cancer Subscale Score (n=6,8) 17.17  (4.021) 21.40  (5.724)
Week 72: Total FACT-G Score (n=6,8) 73.67  (14.820) 79.44  (16.176)
Week 72: Trial Outcome Index (n=6,8) 54.67  (11.911) 61.15  (14.343)
Week 72: Total FACT-L Score (n=6,8) 94.90  (18.833) 105.92  (21.282)
Week 84: Physical Well-Being (n=1,0) 20.00 [1]   (NA) NA [2]   (NA)
Week 84: Social Well-Being (n=1,0) 14.00 [3]   (NA) NA [2]   (NA)
Week 84: Emotional Well-Being (n=1,0) 13.00 [3]   (NA) NA [2]   (NA)
Week 84: Functional Well-Being (n=1,0) 18.00 [3]   (NA) NA [2]   (NA)
Week 84: FACT-L Subscale Score (n=1,0) 17.00 [3]   (NA) NA [2]   (NA)
Week 84: Lung Cancer Subscale Score (n=1,0) 13.00 [3]   (NA) NA [2]   (NA)
Week 84: Total FACT-G Score (n=1,0) 65.00 [3]   (NA) NA [2]   (NA)
Week 84: Trial Outcome Index (n=1,0) 51.00 [3]   (NA) NA [2]   (NA)
Week 84: Total FACT-L Score (n=1,0) 82.00 [3]   (NA) NA [2]   (NA)
Off Trtmt: Physical Well-Being (n=265,215) 19.57  (5.668) 18.50  (5.534)
Off Trtmt: Social Well-Being (n=263,216) 20.01  (5.380) 20.68  (5.265)
Off Trtmt: Emotional Well-Being (n=265,216) 14.76  (5.157) 15.11  (5.183)
Off Trtmt: Functional Well-Being (n=265,216) 14.90  (5.893) 14.58  (5.934)
Off Trtmt: FACT-L Subscale Score (n=264,214) 22.80  (5.268) 22.88  (4.911)
Off Trtmt: Lung Cancer Subscale Score (n=264,214) 18.06  (4.629) 18.16  (4.383)
Off Trtmt:Total FACT-G Score (n=261,214) 69.29  (15.730) 68.94  (15.669)
Off Trtmt:Trial Outcome Index (n=263,213) 52.61  (13.475) 51.34  (12.974)
Off Trtmt:Total FACT-L Score (n=260,212) 92.14  (19.324) 91.89  (18.738)
[1]
Standard deviation (SD) not calculated as only 1 participant was analyzed.
[2]
Zero participants analyzed
[3]
SD not calculated as only 1 participant was analyzed.
36.Secondary Outcome
Title Change From BL in FACT-L Scores (Data Cutoff 17 May 2008)
Hide Description Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0="not at all" and 4="very much"). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0="Not at all" to 4="Very much"; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL.
Time Frame Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants assessed for the given parameter at the specified timepoint.
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description:
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Number of Participants Analyzed 274 303
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 6: Physical Well-Being (n=274,303) 0.22  (4.235) -0.47  (4.729)
Week 6: Social Well-Being (n=274,303) -0.24  (4.901) 0.23  (4.202)
Week 6: Emotional Well-Being (n=274,302) -0.41  (3.801) 0.29  (3.916)
Week 6: Functional Well-Being (n=275,302) 0.24  (4.819) -0.09  (4.711)
Week 6: FACT-L Subscale Score (n=275,298) -0.06  (4.899) 0.24  (4.623)
Week 6: Lung Cancer Subscale Score (n=275,298) -0.32  (4.148) -0.03  (4.160)
Week 6: Total FACT-G Score (n=273,299) -0.20  (12.256) 0.01  (11.453)
Week 6: Trial Outcome Index (n=274,296) 0.16  (10.276) -0.73  (10.201)
Week 6: Total FACT-L Score (n=273,294) -0.20  (15.133) 0.14  (14.155)
Week 12: Physical Well-Being (n=144,193) 1.00  (4.036) -0.14  (4.908)
Week 12: Social Well-Being (n=143,194) -0.43  (4.918) -0.43  (5.566)
Week 12: Emotional Well-Being (n=144,194) 0.25  (3.728) 0.20  (4.115)
Week 12: Functional Well-Being (n=144,196) 1.00  (4.707) -0.38  (4.806)
Week 12: FACT-L Subscale Score (n=144,196) 0.88  (4.501) -0.06  (4.570)
Week 12: Lung Cancer Subscale Score (n=144,196) 0.19  (3.666) -0.48  (4.004)
Week 12: Total FACT-G Score (n=144,191) 1.83  (11.637) -0.84  (12.145)
Week 12: Trial Outcome Index (n=144,193) 2.20  (9.362) -1.04  (10.051)
Week 12: Total FACT-L Score (n=144,191) 2.72  (14.226) -0.90  (14.536)
Week 18: Physical Well-Being (n=86,143) 1.31  (4.798) 0.40  (4.890)
Week 18: Social Well-Being (n=86,143) -0.01  (4.454) -0.51  (5.894)
Week 18: Emotional Well-Being (n=86,143) 0.59  (3.984) 0.60  (3.723)
Week 18: Functional Well-Being (n=86,143) 1.06  (4.353) 0.18  (4.903)
Week 18: FACT-L Subscale Score (n=86,143) 1.48  (4.171) 0.27  (4.587)
Week 18: Lung Cancer Subscale Score (n=86,143) 0.49  (3.550) -0.26  (4.125)
Week 18: Total FACT-G Score (n=86,143) 2.95  (12.047) 0.68  (12.668)
Week 18: Trial Outcome Index (n=86,143) 2.86  (9.638) 0.32  (10.350)
Week 18: Total FACT-L Score (n=86,143) 4.43  (14.523) 0.95  (15.386)
Week 24: Physical Well-Being (n=59,101) 1.29  (4.358) 0.16  (4.881)
Week 24: Social Well-Being (n=59,101) -0.25  (4.804) 0.04  (6.092)
Week 24: Emotional Well-Being (n=59,100) 0.21  (5.118) -0.05  (4.169)
Week 24: Functional Well-Being (n=59,100) 1.64  (4.550) 0.42  (4.373)
Week 24: FACT-L Subscale Score (n=59,101) 1.45  (5.018) 0.50  (5.048)
Week 24: Lung Cancer Subscale Score (n=59,101) 0.48  (4.051) -0.12  (4.321)
Week 24: Total FACT-G Score (n=59,99) 2.89  (13.739) 0.52  (12.753)
Week 24: Trial Outcome Index (n=59,100) 3.42  (9.606) 0.43  (10.348)
Week 24: Total FACT-L Score (n=59,99) 4.34  (16.354) 1.10  (15.954)
Week 30: Physical Well-Being (n=37,66) 1.61  (4.205) 0.49  (5.129)
Week 30: Social Well-Being (n=37,66) 0.00  (5.510) -0.19  (6.676)
Week 30: Emotional Well-Being (n=37,66) -0.07  (4.902) 0.74  (4.775)
Week 30: Functional Well-Being (n=37,66) 2.17  (5.028) 0.83  (5.243)
Week 30: FACT-L Subscale Score (n=37,66) 1.79  (4.616) 0.99  (4.863)
Week 30: Lung Cancer Subscale Score (n=37,66) 0.69  (3.818) 0.38  (4.454)
Week 30: Total FACT-G Score (n=37,66) 3.71  (13.827) 1.88  (14.268)
Week 30: Trial Outcome Index (n=37,66) 4.47  (9.551) 1.70  (11.108)
Week 30: Total FACT-L Score (n=37,66) 5.50  (15.828) 2.86  (16.864)
Week 36: Physical Well-Being (n=25,47) 2.21  (4.791) 0.77  (5.093)
Week 36: Social Well-Being (n=25,47) -0.36  (5.659) -0.16  (7.053)
Week 36: Emotional Well-Being (n=25,47) 0.86  (4.892) 0.65  (3.717)
Week 36: Functional Well-Being (n=25,47) 1.31  (5.551) 1.10  (5.280)
Week 36: FACT-L Subscale Score (n=25,47) 0.67  (4.864) 0.43  (5.459)
Week 36: Lung Cancer Subscale Score (n=25,47) -0.10  (3.963) -0.06  (4.535)
Week 36: Total FACT-G Score (n=25,47) 4.02  (14.439) 2.37  (13.991)
Week 36: Trial Outcome Index (n=25,47) 3.42  (11.186) 1.82  (10.443)
Week 36: Total Fact-L Score (n=25,47) 4.68  (17.636) 2.79  (16.662)
Week 42: Physical Well-Being (n=19,35) 1.82  (3.936) 0.27  (5.835)
Week 42: Social Well-Being (n=19,35) -1.14  (6.006) 0.28  (7.784)
Week 42: Emotional Well-Being (n=19,35) -0.11  (3.573) 0.59  (3.741)
Week 42: Functional Well-Being (n=19,35) 0.05  (3.582) 0.65  (5.580)
Week 42: FACT-L Subscale Score (n=19,35) 1.40  (4.321) 0.87  (4.974)
Week 42: Lung Cancer Subscale Score (n=19,35) 0.42  (2.858) 0.51  (4.301)
Week 42: FACT-G Score (n=19,35) 0.62  (10.871) 1.80  (15.245)
Week 42: Trial Outcome Index (n=19,35) 2.29  (7.037) 1.44  (12.405)
Week 42: FACT-L Score (n=19,35) 2.03  (12.466) 2.67  (18.499)
Week 48: Physical Well-Being (n=13,29) 0.46  (3.497) 1.37  (6.388)
Week 48: Social Well-Being (n=13,29) -1.96  (7.987) -0.68  (6.851)
Week 48: Emotional Well-Being (n=13,29) -0.08  (3.095) 0.41  (4.166)
Week 48: Functional Well-Being (n=13,29) -2.00  (3.894) 0.55  (5.448)
Week 48: FACT-L Subscale Score (n=12,29) 0.03  (4.445) 0.82  (5.967)
Week 48: Lung Cancer Subscale Score (n=12,29) -0.79  (3.100) 0.34  (5.150)
Week 48: Total FACT-G Score (n=13,29) -3.57  (12.233) 1.64  (14.463)
Week 48: Trial Outcome Index (n=12,29) -1.79  (7.570) 2.26  (13.247)
Week 48: Total FACT-L Score (n=12,29) -1.60  (11.354) 2.46  (18.177)
Week 60: Physical Well-Being (n=9,17) 1.89  (5.383) 1.82  (6.307)
Week 60: Social Well-Being (n=9,17) -0.57  (7.368) 0.06  (9.116)
Week 60: Emotional Well-Being (n=9,17) -1.56  (2.789) 0.28  (4.478)
Week 60: Functional Well-Being (n=9,17) -0.56  (3.877) -0.53  (7.434)
Week 60: FACT-L Subscale Score (n=9,17) 1.61  (5.882) 0.43  (6.275)
Week 60: Lung Cancer Subscale Score (n=9,17) -0.22  (4.438) 0.47  (5.535)
Week 60: Total FACT-G Score (n=9,17) -0.79  (12.270) 1.64  (17.542)
Week 60: Trial Outcome Index (n=9,17) 1.11  (11.044) 1.76  (14.316)
Week 60: Total FACT-L Score (n=9,17) 0.82  (15.700) 2.07  (22.086)
Week 72: Physical Well-Being (n=6,8) 1.33  (6.318) 2.63  (7.130)
Week 72: Social Well-Being (n=6,8) 0.31  (6.723) 0.30  (3.733)
Week 72: Emotional Well-Being (n=6,8) -1.50  (3.619) -0.13  (4.853)
Week 72: Functional Well-Being (n=6,8) -1.67  (5.354) -1.13  (5.384)
Week 72: FACT-L Subscale Score (n=6,8) -0.50  (7.396) 1.03  (4.818)
Week 72: Lung Cancer Subscale Score (n=6,8) -1.17  (5.193) 1.78  (4.141)
Week 72: Total FACT-G Score (n=6,8) -1.53  (11.929) 1.67  (14.651)
Week 72: Trial Outcome Index (n=6,8) -1.50  (13.097) 3.28  (13.738)
Week 72: Total FACT-L Score (n=6,8) -2.03  (16.140) 2.70  (17.579)
Week 84: Physical Well-Being (n=1,0) 1.33 [1]   (NA) NA [2]   (NA)
Week 84: Social Well-Being (n=1,0) -2.00 [1]   (NA) NA [2]   (NA)
Week 84: Emotional Well-Being (n=1,0) -3.00 [1]   (NA) NA [2]   (NA)
Week 84: Functional Well-Being (n=1,0) -1.00 [1]   (NA) NA [2]   (NA)
Week 84: FACT-L Subscale Score (n=1,0) 6.0 [1]   (NA) NA [2]   (NA)
Week 84: Lung Cancer Subscale Score (n=1,0) 2.0 [1]   (NA) NA [2]   (NA)
Week 84: Total FACT-G Score (n=1,0) -4.67 [1]   (NA) NA [2]   (NA)
Week 84: Trial Outcome Index (n=1,0) 2.33 [1]   (NA) NA [2]   (NA)
Week 84: Total FACT-L Score (n=1,0) 1.33 [1]   (NA) NA [2]   (NA)
Off Trtmt: Physical Well-Being (n=264,214) -1.07  (4.750) -2.19  (5.506)
Off Trtmt: Social Well-Being (n=263,216) -0.66  (4.973) 0.09  (4.824)
Off Trtmt: Emotional Well-Being (n=264,216) -2.04  (4.225) -1.56  (4.745)
Off Trtmt: Functional Well-Being (n=264,216) -1.20  (5.170) -1.98  (5.355)
Off Trtmt: FACT-L Subscale Score (n=263,212) -1.27  (4.458) -1.32  (4.708)
Off Trtmt: Lung Cancer Subscale Score (n=263,212) -1.74  (3.882) -1.78  (4.199)
Off Trtmt: Total FACT-G Score (n=260,213) -4.91  (12.576) -5.71  (13.588)
Off Trtmt: Trial Outcome Index (n=261,210) -4.03  (10.658) -6.05  (11.785)
Off Trtmt: Total FACT-L Score (n=258,209) -6.26  (15.146) -7.10  (16.194)
[1]
SD not calculated as only 1 participant was analyzed.
[2]
Zero participants were analyzed
Time Frame Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months.
Adverse Event Reporting Description All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
 
Arm/Group Title Placebo Erlotinib, 150 mg/Day
Hide Arm/Group Description Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
All-Cause Mortality
Placebo Erlotinib, 150 mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Erlotinib, 150 mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   34/445 (7.64%)   49/433 (11.32%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/445 (0.00%)  1/433 (0.23%) 
Cardiac disorders     
Cardio-respiratory arrest * 1  0/445 (0.00%)  2/433 (0.46%) 
Cardiac failure * 1  0/445 (0.00%)  1/433 (0.23%) 
Cardiac tamponade * 1  1/445 (0.22%)  0/433 (0.00%) 
Left ventricular dysfunction * 1  0/445 (0.00%)  1/433 (0.23%) 
Myocardial infarction * 1  1/445 (0.22%)  0/433 (0.00%) 
Aortic aneurysm * 1  0/445 (0.00%)  1/433 (0.23%) 
Eye disorders     
Diplopia * 1  1/445 (0.22%)  0/433 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  0/445 (0.00%)  4/433 (0.92%) 
Vomiting * 1  2/445 (0.45%)  0/433 (0.00%) 
Dysphagia * 1  1/445 (0.22%)  0/433 (0.00%) 
Gastric perforation * 1  0/445 (0.00%)  1/433 (0.23%) 
Gastric ulcer perforation * 1  0/445 (0.00%)  1/433 (0.23%) 
Haematemesis * 1  0/445 (0.00%)  1/433 (0.23%) 
General disorders     
Asthenia * 1  1/445 (0.22%)  0/433 (0.00%) 
Chest pain * 1  0/445 (0.00%)  1/433 (0.23%) 
Drowning * 1  0/445 (0.00%)  1/433 (0.23%) 
Pyrexia * 1  0/445 (0.00%)  1/433 (0.23%) 
Sudden death * 1  0/445 (0.00%)  1/433 (0.23%) 
Hepatobiliary disorders     
Cholelithiasis * 1  0/445 (0.00%)  1/433 (0.23%) 
Infections and infestations     
Pneumonia * 1  4/445 (0.90%)  7/433 (1.62%) 
Bronchitis * 1  2/445 (0.45%)  0/433 (0.00%) 
Lower respiratory tract infection * 1  1/445 (0.22%)  1/433 (0.23%) 
Respiratory tract infection * 1  1/445 (0.22%)  1/433 (0.23%) 
Catheter sepsis * 1  1/445 (0.22%)  0/433 (0.00%) 
Cellulitis * 1  0/445 (0.00%)  2/433 (0.46%) 
Empyema * 1  1/445 (0.22%)  0/433 (0.00%) 
Lung abscess * 1  0/445 (0.00%)  1/433 (0.23%) 
Nocardiosis * 1  1/445 (0.22%)  0/433 (0.00%) 
Pyelonephritis acute * 1  0/445 (0.00%)  1/433 (0.23%) 
Sepsis * 1  0/445 (0.00%)  1/433 (0.23%) 
Staphylococcal abscess * 1  0/445 (0.00%)  1/433 (0.23%) 
Upper respiratory tract infection * 1  0/445 (0.00%)  1/433 (0.23%) 
Colitis * 1  0/445 (0.00%)  1/433 (0.23%) 
Injury, poisoning and procedural complications     
Femur fracture * 1  2/445 (0.45%)  0/433 (0.00%) 
Spinal compression fracture * 1  0/445 (0.00%)  1/433 (0.23%) 
Investigations     
Alanine aminotransferase increased * 1  0/445 (0.00%)  1/433 (0.23%) 
Aspartate aminotransferase increased * 1  0/445 (0.00%)  1/433 (0.23%) 
Metabolism and nutrition disorders     
Anorexia * 1  0/445 (0.00%)  1/433 (0.23%) 
Dehydration * 1  0/445 (0.00%)  1/433 (0.23%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness * 1  1/445 (0.22%)  0/433 (0.00%) 
Pain in extremity * 1  1/445 (0.22%)  0/433 (0.00%) 
Nervous system disorders     
Cerebrovascular accident * 1  1/445 (0.22%)  1/433 (0.23%) 
Dizziness * 1  0/445 (0.00%)  1/433 (0.23%) 
Intracranial pressure increased * 1  0/445 (0.00%)  1/433 (0.23%) 
Neuralgia * 1  0/445 (0.00%)  1/433 (0.23%) 
Neuropathy peripheral * 1  0/445 (0.00%)  1/433 (0.23%) 
Peripheral motor neuropathy * 1  0/445 (0.00%)  1/433 (0.23%) 
Sciatica * 1  1/445 (0.22%)  0/433 (0.00%) 
Syncope * 1  0/445 (0.00%)  1/433 (0.23%) 
Psychiatric disorders     
Depression * 1  0/445 (0.00%)  1/433 (0.23%) 
Panic attack * 1  0/445 (0.00%)  1/433 (0.23%) 
Renal and urinary disorders     
Renal failure acute * 1  0/445 (0.00%)  1/433 (0.23%) 
Urogenital haemorrhage * 1  0/445 (0.00%)  1/433 (0.23%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  2/445 (0.45%)  2/433 (0.46%) 
Haemoptysis * 1  2/445 (0.45%)  1/433 (0.23%) 
Interstitial lung disease * 1  0/445 (0.00%)  2/433 (0.46%) 
Pleural effusion * 1  1/445 (0.22%)  1/433 (0.23%) 
Pulmonary embolism * 1  2/445 (0.45%)  0/433 (0.00%) 
Bronchospasm * 1  1/445 (0.22%)  0/433 (0.00%) 
Chronic obstructive pulmonary disease * 1  1/445 (0.22%)  0/433 (0.00%) 
Epistaxis * 1  1/445 (0.22%)  0/433 (0.00%) 
Pleural fistula * 1  0/445 (0.00%)  1/433 (0.23%) 
Pneumonia aspiration * 1  1/445 (0.22%)  0/433 (0.00%) 
Pulmonary fibrosis * 1  0/445 (0.00%)  1/433 (0.23%) 
Respiratory failure * 1  0/445 (0.00%)  1/433 (0.23%) 
Skin and subcutaneous tissue disorders     
Rash * 1  0/445 (0.00%)  2/433 (0.46%) 
Vascular disorders     
Peripheral ischaemia * 1  1/445 (0.22%)  1/433 (0.23%) 
Arterial thrombosis * 1  1/445 (0.22%)  0/433 (0.00%) 
Arteritis * 1  1/445 (0.22%)  0/433 (0.00%) 
Deep vein thrombosis * 1  1/445 (0.22%)  0/433 (0.00%) 
Iliac artery thrombosis * 1  0/445 (0.00%)  1/433 (0.23%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Erlotinib, 150 mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   152/445 (34.16%)   283/433 (65.36%) 
Gastrointestinal disorders     
Diarrhoea * 1  20/445 (4.49%)  87/433 (20.09%) 
Nausea * 1  27/445 (6.07%)  33/433 (7.62%) 
General disorders     
Fatigue * 1  26/445 (5.84%)  39/433 (9.01%) 
Chest pain * 1  28/445 (6.29%)  14/433 (3.23%) 
Metabolism and nutrition disorders     
Anorexia * 1  22/445 (4.94%)  39/433 (9.01%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  38/445 (8.54%)  36/433 (8.31%) 
Dyspnoea * 1  37/445 (8.31%)  33/433 (7.62%) 
Haemoptysis * 1  21/445 (4.72%)  22/433 (5.08%) 
Skin and subcutaneous tissue disorders     
Rash * 1  26/445 (5.84%)  211/433 (48.73%) 
Pruritus * 1  12/445 (2.70%)  32/433 (7.39%) 
Acne * 1  0/445 (0.00%)  27/433 (6.24%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00556712     History of Changes
Other Study ID Numbers: BO18192
First Submitted: November 9, 2007
First Posted: November 12, 2007
Results First Submitted: December 4, 2014
Results First Posted: February 11, 2015
Last Update Posted: February 11, 2015