Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00556322
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: Alimta or Taxotere
Drug: erlotinib [Tarceva]
Enrollment 424
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description Participants received either pemetrexed 500 milligrams per square meter (mg/m^2) every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label. Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Period Title: Overall Study
Started 221 203
Completed 0 [1] 0 [1]
Not Completed 221 203
Reason Not Completed
Insufficient therapeutic response             158             168
Adverse Event             7             4
Other             4             1
Lost to Follow-up             5             3
Withdrawal by Subject             19             7
Protocol Violation             5             1
Ongoing at data cutoff             3             5
Death             20             14
[1]
Data cutoff was 01 August 2010
Arm/Group Title Comparator Erlotinib Total
Hide Arm/Group Description Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label. Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death. Total of all reporting groups
Overall Number of Baseline Participants 221 203 424
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): All participants randomized were included according to the therapy that they were randomized to receive in the FAS population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 221 participants 203 participants 424 participants
58.3  (9.90) 58.6  (9.64) 58.4  (9.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 203 participants 424 participants
Female
61
  27.6%
42
  20.7%
103
  24.3%
Male
160
  72.4%
161
  79.3%
321
  75.7%
1.Primary Outcome
Title Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010)
Hide Description Overall survival (OS) was determined from the date of randomization to the date of death irrespective of the cause of death.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 or Death and Every 12 Weeks until Death or Data Cut off (07 September 2010) up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 221 203
Measure Type: Number
Unit of Measure: percentage of participants
81.0 77.8
2.Primary Outcome
Title Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010)
Hide Description OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 221 203
Median (95% Confidence Interval)
Unit of Measure: months
5.5
(4.4 to 7.1)
5.3
(4.0 to 6.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comparator, Erlotinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7299
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%
0.78 to 1.19
Estimation Comments [Not Specified]
3.Primary Outcome
Title Probable Percentage of Participants Remaining Alive at 1 Year
Hide Description OS was determined from the date of randomization to the date of death irrespective of the cause of death. Kaplan-Meier estimates were used for analysis.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 221 203
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.0
(18.0 to 30.0)
26.0
(19.0 to 32.0)
4.Secondary Outcome
Title Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population
Hide Description EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by immunohistochemistry (IHC). OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. number (n) equals (=) number of participants who were EGFR positive or negative
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 188 175
Measure Type: Number
Unit of Measure: percentage of participants
EGFR Positive (n=149,143) 79.9 76.9
EGFR Negative (n=39,32) 79.5 75.0
5.Secondary Outcome
Title Duration of OS in EGFR Positive and Negative Population
Hide Description EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Death or Until Data Cut off (07 September 2010) up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 188 175
Median (95% Confidence Interval)
Unit of Measure: months
EGFR Positive (n=149,143)
5.5
(4.1 to 7.5)
5.6
(4.0 to 7.6)
EGFR Negative (n=39,32)
6.7
(3.1 to 11.5)
5.4
(3.7 to 7.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comparator, Erlotinib
Comments Comparison of EGFR positive populations
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6198
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.72 to 1.21
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Comparator, Erlotinib
Comments Comparison of EGFR negative populations
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8398
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio, log
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.55 to 1.62
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population
Hide Description EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. OS was determined from the date of randomization to the date of death irrespective of the cause of death in EGFR positive and negative populations. Kaplan-Meier estimates were used for analysis.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; n=number of EGFR positive or negative participants remaining at risk
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel l75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 221 203
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
EGFR Positive (n=30,32)
27.0
(19.0 to 34.0)
30.0
(22.0 to 38.0)
EGFR Negative (n=8,4)
28.0
(12.0 to 43.0)
20.0
(4.0 to 36.0)
7.Secondary Outcome
Title Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010)
Hide Description Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.0). Progressive Disease was defined as at least a 20 percent (%) increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The primary analysis of PFS used objective progression (RECIST) plus clinical progression (based on relevant clinical findings - if any). A further assessment of PFS was made on objective (radiological) progression. If clinical progression was diagnosed first, the participant was censored at the date of the last tumor assessment, where non-progression was documented.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 221 203
Measure Type: Number
Unit of Measure: percentage of participants
83.3 92.6
8.Secondary Outcome
Title Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010)
Hide Description Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 221 203
Median (95% Confidence Interval)
Unit of Measure: weeks
8.6
(7.1 to 12.1)
6.3
(6.1 to 6.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comparator, Erlotinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0885
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.97 to 1.46
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months
Hide Description Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Event free estimates were determined using Kaplan-Meier estimates.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 221 203
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
17.0
(12.0 to 22.0)
13.0
(8.0 to 18.0)
10.Secondary Outcome
Title Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010)
Hide Description EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC.Tumor response was evaluated according to RECIST criteria (version 1.0). Progressive Disease was defined as At least a 20 % increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only participants with confirmed presence or absence of EGFR were included in the analysis. n=number of participants who were EGFR positive or negative
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 188 175
Measure Type: Number
Unit of Measure: percentage of participants
EGFR Positive (n=149,143) 79.9 93.7
EGFR Negative (n=39,32) 89.7 90.6
11.Secondary Outcome
Title PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010)
Hide Description EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Kaplan-Meier estimates were used for analysis.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Until Data Cut off (07 September 2010) up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only Participants with confirmed status of EGFR were included in the analysis; number of participants who were EGFR positive or negative
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 188 175
Median (95% Confidence Interval)
Unit of Measure: weeks
EGFR Positive (n=149,143)
8.9
(7.1 to 12.6)
6.3
(6.1 to 7.3)
EGFR Negative (n=39,32)
11.5
(6.7 to 14.7)
6.7
(5.9 to 12.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comparator, Erlotinib
Comments Comparison of EGFR positive populations
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0662
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.98 to 1.61
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Comparator, Erlotinib
Comments Comparison of EGFR negative populations
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9403
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.61 to 1.69
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months in EGFR Positive and Negative Population
Hide Description EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR was determined by IHC. Tumor response was evaluated according to RECIST criteria (version 1.0). PFS was defined as time from randomization to the date of documented disease progression or death, whichever occurred first in EGFR positive and negative populations. Participants without progression were censored at the date of last tumor assessment where non progression was documented. If a participant receives a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Event free estimates were determined using Kaplan-Meier estimates.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; n=number of EGFR positive or negative participants who remained at risk
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable t oxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 221 203
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
EGFR Positive (n=23,18)
20.0
(13.0 to 28.0)
13.0
(7.0 to 19.0)
EGFR Negative (n=4,5)
11.0
(1.0 to 21.0)
16.0
(3.0 to 29.0)
13.Secondary Outcome
Title Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST
Hide Description Best overall response was defined as the best response according to RECIST recorded from the date of randomization until disease progression or recurrence. CR: disappearance of all target lesions; PR: reduction by at least 30% of the sum of the longest diameters of each target lesion, taking the initial sum of the longest diameters as a reference; Stable disease (SD): insufficient tumor reduction to define partial response and/or tumor increase less than that necessary to define tumor progression, taking as a reference the smallest sum of the longest diameter since the start of treatment; Progressive Disease (PD): increase by at least 20% in the sum of LD of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. 95% Confidence Interval (CI) for one sample binomial using Pearson-Clopper method. Participants with a missing response were considered non-responders.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity or Death or up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received a single oral dose of erlotinib 150 mg/day as a tablet until disease progression, unacceptable toxicity or death.
Overall Number of Participants Analyzed 221 203
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.3
(3.5 to 10.4)
7.9
(4.6 to 12.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comparator, Erlotinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5349
Comments p-values are based on non-stratified analysis
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
-3.6 to 6.7
Estimation Comments Approximate 95% CI for the difference of two rates was determined using Hauck-Anderson Method
14.Secondary Outcome
Title Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L)
Hide Description The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the Functional Assessment of Cancer Treatment-General scale (FACT-G) and the lung cancer subscale (LCS). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 165 157
Measure Type: Number
Unit of Measure: percentage of participants
66.1 66.9
15.Secondary Outcome
Title Time to Deterioration in Quality of Life Using FACT-L
Hide Description The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Time to deterioration of QoL or symptom progression is defined as time from randomization until either a clinically meaningful decline from baseline in Total FACT-L or, death on study, whichever occurs first. The clinically meaningful decline that was used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Kaplan-Meier estimate was used to determine time to event.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 165 157
Median (95% Confidence Interval)
Unit of Measure: weeks
9.0
(7.1 to 11.6)
6.3
(6.1 to 8.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comparator, Erlotinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1498
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.93 to 1.59
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L
Hide Description The FACT-L measures health related QOL and composes of five domains: the four domains (physical well being, emotional well being, social well being, functional well being) from the FACT-G and the LCS. The FACT-L total score ranges from 0 to 136, higher scores represent better QOL. Kaplan Meier estimates were used for analysis.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 165 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.0
(17.0 to 34.0)
19.0
(11.0 to 26.0)
17.Secondary Outcome
Title Percentage of Participants With Symptomatic Progression Using FACT-L
Hide Description Participants’ responses on the FACT-L were scored according to the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 165 158
Measure Type: Number
Unit of Measure: percentage of participants
60.6 62.0
18.Secondary Outcome
Title Time to Symptomatic Progression Using FACT-L
Hide Description Participants’ responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 165 158
Median (95% Confidence Interval)
Unit of Measure: weeks
9.0
(7.0 to 12.1)
7.1
(6.1 to 9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comparator, Erlotinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2202
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.90 to 1.57
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L
Hide Description Participants’ responses on the FACT-L were scored according to FACIT measurement system manual. Time to symptom progression is the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. A change in 2 to 3 points on the LCS is a clinically meaningful change. Meaningful declines in scores as measured by the FACIT instruments have been found to be larger than improvements. Thus, deterioration in disease-related symptoms was defined by the upper bound (3 points) of the range of clinically meaningful change. However, participants who demonstrated early lung cancer progression demonstrated smaller changes from baseline score on the LCS. Therefore, the clinically meaningful decline that was used to determine progression of symptoms in this study was at least 1.5-point decline in LCS score from baseline. Kaplan Meier estimated were used for analysis.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 165 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
27
(18 to 36)
27
(18 to 35)
20.Secondary Outcome
Title Percentage of Participants With Deterioration in the Trial Outcome Index (TOI)
Hide Description TOI is defined as the sum of the scores of the Physical Well- Being (PWB), Functional Well-Being (FWB), and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 165 158
Measure Type: Number
Unit of Measure: percentage of participants
60.0 63.3
21.Secondary Outcome
Title Time to Deterioration in the TOI
Hide Description TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6- point decline from baseline. Kaplan-Meier estimates were used for analysis.
Time Frame Baseline, Weeks 3 and 6, Every 3 Weeks until Week 48 and Every 12 Weeks until Disease Progression or unacceptable toxicity up to 52 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 165 158
Median (95% Confidence Interval)
Unit of Measure: weeks
9.3
(7.6 to 13.0)
6.7
(6.1 to 9.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Comparator, Erlotinib
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1063
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.95 to 1.66
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L
Hide Description TOI is defined as the sum of the scores of the PW, FWB, and LCS of the FACT-L instrument. Trial Outcome Index measures the physical functioning of participants. Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. The clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Kaplan-Meier estimates were used for analysis.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Only participants with both a baseline FACT-L assessment and a subsequent FACT-L assessment were included in the analysis.
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description:
Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
Overall Number of Participants Analyzed 165 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28
(19 to 37)
21
(13 to 29)
Time Frame All adverse events (related and unrelated) occurring during the study and for up to 28 days after the last dose of study medication were reported.
Adverse Event Reporting Description All participants who received at least one dose of the trial medication and had at least one safety follow-up, whether withdrawn prematurely or not, were included in the safety analysis population (SAP).
 
Arm/Group Title Comparator Erlotinib
Hide Arm/Group Description Participants received either Alimta 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or Taxotere 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, Taxotere was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label. Participants received a single oral dose of erlotinib 150 mg/day until disease progression, unacceptable toxicity or death.
All-Cause Mortality
Comparator Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Comparator Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   31/213 (14.55%)   20/196 (10.20%) 
Blood and lymphatic system disorders     
Anaemia * 1  4/213 (1.88%)  0/196 (0.00%) 
Febrile neutropenia * 1  2/213 (0.94%)  0/196 (0.00%) 
Neutropenia * 1  2/213 (0.94%)  0/196 (0.00%) 
Pancytopenia * 1  1/213 (0.47%)  0/196 (0.00%) 
Thrombocytopenia * 1  1/213 (0.47%)  0/196 (0.00%) 
Cardiac disorders     
Supraventricular tachycardia * 1  1/213 (0.47%)  1/196 (0.51%) 
Cardiac failure * 1  1/213 (0.47%)  0/196 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  2/213 (0.94%)  0/196 (0.00%) 
Constipation * 1  2/213 (0.94%)  0/196 (0.00%) 
Enterocolitis * 1  1/213 (0.47%)  0/196 (0.00%) 
Gastric perforation * 1  1/213 (0.47%)  0/196 (0.00%) 
Oesophagitis * 1  1/213 (0.47%)  0/196 (0.00%) 
Proctitis * 1  0/213 (0.00%)  1/196 (0.51%) 
Subileus * 1  0/213 (0.00%)  1/196 (0.51%) 
Upper gastrointestinal haemorrhage * 1  1/213 (0.47%)  0/196 (0.00%) 
General disorders     
Death * 1  2/213 (0.94%)  0/196 (0.00%) 
Chest pain * 1  1/213 (0.47%)  0/196 (0.00%) 
Pyrexia * 1  1/213 (0.47%)  0/196 (0.00%) 
Infections and infestations     
Pneumonia * 1  3/213 (1.41%)  1/196 (0.51%) 
Erysipelas * 1  1/213 (0.47%)  0/196 (0.00%) 
Gastroenteritis * 1  0/213 (0.00%)  1/196 (0.51%) 
Lower respiratory tract infection * 1  0/213 (0.00%)  1/196 (0.51%) 
Pharyngitis bacterial * 1  0/213 (0.00%)  1/196 (0.51%) 
Injury, poisoning and procedural complications     
Narcotic intoxication * 1  0/213 (0.00%)  1/196 (0.51%) 
Vascular access complication * 1  1/213 (0.47%)  0/196 (0.00%) 
Metabolism and nutrition disorders     
Hypercalcaemia * 1  0/213 (0.00%)  1/196 (0.51%) 
Hypokalaemia * 1  0/213 (0.00%)  1/196 (0.51%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/213 (0.47%)  1/196 (0.51%) 
Nervous system disorders     
Cerebrovascular accident * 1  1/213 (0.47%)  0/196 (0.00%) 
Ischaemic stroke * 1  1/213 (0.47%)  0/196 (0.00%) 
Spinal cord compression * 1  0/213 (0.00%)  1/196 (0.51%) 
Renal and urinary disorders     
Renal failure * 1  1/213 (0.47%)  0/196 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  0/213 (0.00%)  4/196 (2.04%) 
Haemoptysis * 1  2/213 (0.94%)  1/196 (0.51%) 
Chronic obstructive pulmonary disease * 1  1/213 (0.47%)  0/196 (0.00%) 
Pulmonary effusion * 1  0/213 (0.00%)  1/196 (0.51%) 
Pneumothorax * 1  0/213 (0.00%)  1/196 (0.51%) 
Pulmonary haemorrhage * 1  1/213 (0.47%)  0/196 (0.00%) 
Vascular disorders     
Venous thrombosis limb * 1  1/213 (0.47%)  1/196 (0.51%) 
Deep vein thrombosis * 1  0/213 (0.00%)  1/196 (0.51%) 
Vena cava thrombosis * 1  1/213 (0.47%)  0/196 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Comparator Erlotinib
Affected / at Risk (%) Affected / at Risk (%)
Total   106/213 (49.77%)   125/196 (63.78%) 
Blood and lymphatic system disorders     
Anaemia * 1  16/213 (7.51%)  4/196 (2.04%) 
Gastrointestinal disorders     
Diarrhoea * 1  12/213 (5.63%)  37/196 (18.88%) 
Nausea * 1  29/213 (13.62%)  15/196 (7.65%) 
General disorders     
Asthenia * 1  22/213 (10.33%)  13/196 (6.63%) 
Fatigue * 1  18/213 (8.45%)  9/196 (4.59%) 
Pyrexia * 1  14/213 (6.57%)  10/196 (5.10%) 
Chest pain * 1  6/213 (2.82%)  10/196 (5.10%) 
Oedema peripheral * 1  11/213 (5.16%)  3/196 (1.53%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  22/213 (10.33%)  17/196 (8.67%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  25/213 (11.74%)  20/196 (10.20%) 
Cough * 1  19/213 (8.92%)  15/196 (7.65%) 
Skin and subcutaneous tissue disorders     
Rash * 1  7/213 (3.29%)  74/196 (37.76%) 
Alopecia * 1  25/213 (11.74%)  0/196 (0.00%) 
Dermatitis acneiform * 1  1/213 (0.47%)  12/196 (6.12%) 
Acne * 1  0/213 (0.00%)  11/196 (5.61%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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 after the first publication or presentation that involves the overall study. 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: Hoffmann- LaRoche
Phone: 1-800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00556322     History of Changes
Other Study ID Numbers: BO18602
First Submitted: November 9, 2007
First Posted: November 12, 2007
Results First Submitted: December 3, 2014
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015