Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)

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: NCT02657434
Recruitment Status : Active, not recruiting
First Posted : January 15, 2016
Results First Posted : October 9, 2020
Last Update Posted : October 29, 2020
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: Atezolizumab
Drug: Carboplatin
Drug: Cisplatin
Drug: Pemetrexed
Enrollment 578
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Period Title: Overall Study
Started 286 292
Completed 0 0
Not Completed 286 292
Reason Not Completed
On-Going in Study             77             91
Death             177             183
Lost to Follow-up             2             2
Randomization by Error             2             0
Withdrawal by Subject             27             16
Protocol Violation             1             0
Arm/Group Title Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed Total
Hide Arm/Group Description Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase will begin maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. Total of all reporting groups
Overall Number of Baseline Participants 286 292 578
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 286 participants 292 participants 578 participants
61.8  (9.3) 63.3  (9.4) 62.6  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 292 participants 578 participants
Female
94
  32.9%
100
  34.2%
194
  33.6%
Male
192
  67.1%
192
  65.8%
384
  66.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 292 participants 578 participants
Hispanic or Latino
21
   7.3%
17
   5.8%
38
   6.6%
Not Hispanic or Latino
241
  84.3%
243
  83.2%
484
  83.7%
Unknown or Not Reported
24
   8.4%
32
  11.0%
56
   9.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 292 participants 578 participants
American Indian or Alaska Native
1
   0.3%
1
   0.3%
2
   0.3%
Asian
65
  22.7%
71
  24.3%
136
  23.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   1.4%
2
   0.7%
6
   1.0%
White
203
  71.0%
193
  66.1%
396
  68.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
13
   4.5%
25
   8.6%
38
   6.6%
1.Primary Outcome
Title Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Hide Description PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurred first.
Time Frame Randomization up to approximately 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all randomized patients, whether or not the patients received the assigned treatment.
Arm/Group Title Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 286 292
Median (95% Confidence Interval)
Unit of Measure: Months
5.2
(4.3 to 5.6)
7.7
(6.7 to 8.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B (Carboplatin or Cisplatin + Pemetrexed), Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Comments [Not Specified]
Type of Statistical Test Other
Comments Unstratified Analysis
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio, log
Estimated Value 0.562
Confidence Interval (2-Sided) 95%
0.471 to 0.671
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as time from randomization to death from any cause.
Time Frame Randomization up to approximately 39 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all randomized patients, whether or not the patients received the assigned treatment.
Arm/Group Title Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 286 292
Median (95% Confidence Interval)
Unit of Measure: Months
13.6
(11.0 to 15.7)
17.5
(13.2 to 19.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B (Carboplatin or Cisplatin + Pemetrexed), Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Unstratified Analysis
Statistical Test of Hypothesis P-Value 0.1559
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.866
Confidence Interval (2-Sided) 95%
0.709 to 1.056
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm B (Carboplatin or Cisplatin + Pemetrexed), Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Stratified Analysis
Statistical Test of Hypothesis P-Value 0.1546
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.864
Confidence Interval (2-Sided) 95%
0.707 to 1.056
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival Rate at Year 1
Hide Description The Overall Survival Rate at the 1-year landmark time point is defined as the probabilities that participants are alive 1-year after randomization.
Time Frame Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all randomized patients, whether or not the patients received the assigned treatment.
Arm/Group Title Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 286 292
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
55.04
(49.21 to 60.87)
59.72
(54.02 to 65.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B (Carboplatin or Cisplatin + Pemetrexed), Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2606
Comments [Not Specified]
Method z test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in event free rate
Estimated Value 4.68
Confidence Interval (2-Sided) 95%
-3.47 to 12.83
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Overall Survival Rate Year 2
Hide Description The Overall Survival Rate at the 2-year landmark time point is defined as the probabilities that participants are alive 2-years after randomization.
Time Frame Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 286 292
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
34.01
(28.40 to 39.62)
39.13
(33.44 to 44.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B (Carboplatin or Cisplatin + Pemetrexed), Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2090
Comments [Not Specified]
Method Z-test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Event Free Rate
Estimated Value 5.12
Confidence Interval (2-Sided) 95%
-2.87 to 13.11
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1
Hide Description An objective response is defined as either an unconfirmed CR or a PR, as determined by the investigator using RECIST v1.1. Objective Response Rate is defined as the proportion of patients who had an objective response.
Time Frame Randomization up to approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was defined as all randomized patients, whether or not the patients received the assigned treatment.
Arm/Group Title Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 286 292
Measure Type: Number
Unit of Measure: Percentage of Participants
Responders 37.4 51.7
Non-Responders 62.6 48.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B (Carboplatin or Cisplatin + Pemetrexed), Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 14.3
Confidence Interval (2-Sided) 95%
5.9 to 22.7
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1
Hide Description DOR is defined as the time interval from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented, whichever occurs first.
Time Frame Randomization up to approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
DOR was assessed in participants who had an objective response as determined by the investigator using RECIST v1.1.
Arm/Group Title Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 286 292
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Months
6.4
(4.4 to 7.6)
9.5
(6.9 to 12.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm B (Carboplatin or Cisplatin + Pemetrexed), Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.45 to 0.85
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Hide Description EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).
Time Frame Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with a non-missing baseline and at least a post-baseline PRO assessment (i.e., PRO evaluable population).
Arm/Group Title Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 232 242
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Dyspnoea: Week 3 Number Analyzed 222 participants 216 participants
-1.95  (23.97) -1.39  (25.17)
Dyspnoea: Week 6 Number Analyzed 189 participants 198 participants
-1.23  (23.16) -4.71  (26.66)
Dyspnoea: Week 9 Number Analyzed 166 participants 179 participants
0.20  (26.34) -6.33  (26.62)
Dyspnoea: Week 12 Number Analyzed 147 participants 177 participants
-0.91  (27.57) -3.39  (29.10)
Dyspnoea: Week 15 Number Analyzed 140 participants 164 participants
-1.67  (28.92) -2.44  (28.73)
Dyspnoea: Week 18 Number Analyzed 126 participants 155 participants
-2.12  (24.85) -3.44  (30.43)
Dyspnoea: Week 21 Number Analyzed 100 participants 150 participants
-5.67  (29.61) -2.89  (31.83)
Dyspnoea: Week 24 Number Analyzed 97 participants 136 participants
-2.75  (28.74) -2.45  (31.85)
Dyspnoea: Week 27 Number Analyzed 79 participants 126 participants
-2.53  (31.47) -1.32  (27.13)
Dyspnoea: Week 30 Number Analyzed 80 participants 123 participants
-1.25  (32.45) -2.71  (28.50)
Dyspnoea: Week 33 Number Analyzed 73 participants 107 participants
-1.83  (27.15) -3.74  (30.14)
Dyspnoea: Week 36 Number Analyzed 61 participants 105 participants
-3.83  (30.49) -6.67  (31.49)
Dyspnoea: Week 39 Number Analyzed 60 participants 95 participants
-1.67  (31.55) -8.42  (29.16)
Dyspnoea: Week 42 Number Analyzed 51 participants 95 participants
-3.27  (28.48) -9.12  (28.12)
Dyspnoea: Week 45 Number Analyzed 48 participants 79 participants
-6.25  (32.00) -2.11  (30.82)
Dyspnoea: Week 48 Number Analyzed 39 participants 81 participants
-5.13  (32.03) -7.41  (26.87)
Dyspnoea: Week 51 Number Analyzed 36 participants 80 participants
-14.81  (30.28) -2.92  (26.09)
Dyspnoea: Week 54 Number Analyzed 31 participants 72 participants
-9.68  (35.69) -2.78  (27.26)
Dyspnoea: Week 57 Number Analyzed 26 participants 71 participants
-7.69  (28.76) -5.63  (28.72)
Dyspnoea: Week 60 Number Analyzed 18 participants 56 participants
-11.11  (25.57) 0.00  (25.43)
Dyspnoea: Week 63 Number Analyzed 13 participants 39 participants
-7.69  (14.62) -5.13  (23.62)
Dyspnoea: Week 66 Number Analyzed 7 participants 37 participants
-9.52  (16.27) -1.80  (24.78)
Dyspnoea: Week 69 Number Analyzed 6 participants 28 participants
-16.67  (18.26) -3.57  (24.58)
Dyspnoea: Week 72 Number Analyzed 8 participants 22 participants
-4.17  (27.82) 0.00  (27.22)
Dyspnoea: Week 75 Number Analyzed 5 participants 23 participants
-6.67  (14.91) -5.80  (19.21)
Dyspnoea: Week 78 Number Analyzed 2 participants 14 participants
0.00  (0.00) -4.76  (25.68)
Dyspnoea: Week 81 Number Analyzed 2 participants 9 participants
0.00  (0.00) -11.11  (23.57)
Dyspnoea: Week 84 Number Analyzed 2 participants 8 participants
0.00  (0.00) -4.17  (21.36)
Dyspnoea: Week 87 Number Analyzed 1 participants 4 participants
0.00 [1]   (NA) 8.33  (16.67)
Dyspnoea: Week 90 Number Analyzed 1 participants 2 participants
0.00 [1]   (NA) 0.00  (0.00)
Dyspnoea: Week 93 Number Analyzed 0 participants 1 participants
0.00 [1]   (NA)
Dyspnoea: Time of First Pd Number Analyzed 0 participants 0 participants
Dyspnoea: Time of Last Tx Dose Number Analyzed 0 participants 0 participants
Dyspnoea: Survival Follow-Up Week 12 Number Analyzed 29 participants 25 participants
9.20  (35.52) 8.00  (42.25)
Dyspnoea: Survival Follow-Up Week 24 Number Analyzed 19 participants 7 participants
5.26  (25.49) -14.29  (17.82)
[1]
Only 1 participant.
8.Secondary Outcome
Title Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Hide Description The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).
Time Frame Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with a non-missing baseline and at least a post-baseline PRO assessment (i.e., PRO evaluable population).
Arm/Group Title Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 230 234
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Coughing: Week 3 Number Analyzed 213 participants 205 participants
-2.50  (25.37) -3.41  (26.90)
Coughing: Week 6 Number Analyzed 187 participants 190 participants
-3.57  (27.20) -9.82  (26.50)
Coughing: Week 9 Number Analyzed 162 participants 173 participants
-1.85  (24.43) -8.29  (31.37)
Coughing: Week 12 Number Analyzed 145 participants 168 participants
-3.91  (28.46) -10.71  (31.66)
Coughing: Week 15 Number Analyzed 137 participants 159 participants
-6.33  (30.39) -11.53  (29.05)
Coughing: Week 18 Number Analyzed 125 participants 149 participants
-4.00  (26.97) -11.63  (27.92)
Coughing: Week 21 Number Analyzed 100 participants 146 participants
-6.00  (27.78) -10.50  (30.76)
Coughing: Week 24 Number Analyzed 97 participants 133 participants
-4.81  (28.05) -10.03  (33.08)
Coughing: Week 27 Number Analyzed 78 participants 123 participants
-3.85  (26.85) -11.65  (34.40)
Coughing: Week 30 Number Analyzed 80 participants 120 participants
0.42  (29.76) -11.39  (31.31)
Coughing: Week 33 Number Analyzed 72 participants 103 participants
-0.46  (26.53) -11.97  (30.91)
Coughing: Week 36 Number Analyzed 60 participants 103 participants
-6.11  (31.59) -12.94  (30.33)
Coughing: Week 39 Number Analyzed 60 participants 92 participants
-5.00  (30.58) -13.41  (32.43)
Coughing: Week 42 Number Analyzed 52 participants 93 participants
-8.97  (27.31) -14.70  (29.68)
Coughing: Week 45 Number Analyzed 48 participants 77 participants
-13.19  (28.13) -14.72  (27.83)
Coughing: Week 48 Number Analyzed 39 participants 79 participants
-7.69  (31.96) -13.92  (32.29)
Coughing: Week 51 Number Analyzed 36 participants 79 participants
-17.59  (25.80) -10.97  (34.48)
Coughing: Week 54 Number Analyzed 31 participants 70 participants
-17.20  (27.04) -13.81  (33.81)
Coughing: Week 57 Number Analyzed 26 participants 69 participants
-11.54  (22.98) -13.53  (29.33)
Coughing: Week 60 Number Analyzed 19 participants 56 participants
-14.04  (27.92) -10.71  (31.21)
Coughing: Week 63 Number Analyzed 13 participants 39 participants
-10.26  (21.01) -12.82  (27.16)
Coughing: Week 66 Number Analyzed 7 participants 37 participants
-9.52  (25.20) -12.61  (28.71)
Coughing: Week 69 Number Analyzed 6 participants 28 participants
-11.11  (27.22) -11.90  (30.38)
Coughing: Week 72 Number Analyzed 8 participants 22 participants
-8.33  (23.57) -16.67  (30.43)
Coughing: Week 75 Number Analyzed 5 participants 23 participants
-13.33  (18.26) -18.84  (28.12)
Coughing: Week 78 Number Analyzed 2 participants 14 participants
-16.67  (23.57) -23.81  (27.51)
Coughing: Week 81 Number Analyzed 2 participants 9 participants
-16.67  (23.57) -18.52  (33.79)
Coughing: Week 84 Number Analyzed 2 participants 8 participants
-33.33  (0.00) -29.17  (27.82)
Coughing: Week 87 Number Analyzed 1 participants 4 participants
0.00 [1]   (NA) -25.00  (31.91)
Coughing: Week 90 Number Analyzed 1 participants 2 participants
-33.33 [1]   (NA) -16.67  (23.57)
Coughing: Week 93 Number Analyzed 0 participants 1 participants
0.00 [1]   (NA)
Coughing: Time of First Pd Number Analyzed 61 participants 70 participants
-6.01  (30.13) -10.48  (28.68)
Coughing: Time of Last Tx Dose Number Analyzed 199 participants 201 participants
-5.19  (28.05) -8.13  (28.78)
Coughing: Survival Follow-Up Week 12 Number Analyzed 28 participants 24 participants
3.57  (29.17) -6.94  (34.02)
Coughing: Survival Follow-Up Week 24 Number Analyzed 19 participants 7 participants
-8.77  (24.45) -14.29  (32.53)
Dyspnoea: Week 3 Number Analyzed 213 participants 205 participants
0.21  (18.69) -1.41  (17.68)
Dyspnoea: Week 6 Number Analyzed 187 participants 190 participants
0.12  (17.13) -1.17  (18.85)
Dyspnoea: Week 9 Number Analyzed 162 participants 173 participants
0.89  (20.68) -3.34  (18.65)
Dyspnoea: Week 12 Number Analyzed 145 participants 168 participants
1.15  (21.82) -0.46  (21.76)
Dyspnoea: Week 15 Number Analyzed 137 participants 159 participants
0.00  (21.30) -1.12  (20.78)
Dyspnoea: Week 18 Number Analyzed 125 participants 149 participants
-1.07  (18.90) -3.88  (21.92)
Dyspnoea: Week 21 Number Analyzed 100 participants 146 participants
-3.56  (22.77) -1.45  (21.85)
Dyspnoea: Week 24 Number Analyzed 97 participants 133 participants
-2.29  (21.75) -0.42  (23.82)
Dyspnoea: Week 27 Number Analyzed 78 participants 123 participants
-0.71  (22.32) -2.08  (19.83)
Dyspnoea: Week 30 Number Analyzed 80 participants 120 participants
1.25  (22.57) -2.78  (20.33)
Dyspnoea: Week 33 Number Analyzed 72 participants 103 participants
0.77  (21.45) -3.02  (22.82)
Dyspnoea: Week 36 Number Analyzed 60 participants 103 participants
-1.11  (20.93) -2.91  (23.70)
Dyspnoea: Week 39 Number Analyzed 60 participants 92 participants
1.30  (26.91) -4.95  (22.31)
Dyspnoea: Week 42 Number Analyzed 52 participants 93 participants
-0.43  (22.65) -6.33  (18.64)
Dyspnoea: Week 45 Number Analyzed 48 participants 77 participants
-2.08  (26.60) -3.61  (21.36)
Dyspnoea: Week 48 Number Analyzed 39 participants 79 participants
-4.56  (24.94) -5.34  (21.49)
Dyspnoea: Week 51 Number Analyzed 36 participants 79 participants
-9.88  (21.87) -1.69  (18.41)
Dyspnoea: Week 54 Number Analyzed 31 participants 70 participants
-6.45  (24.47) -1.90  (19.10)
Dyspnoea: Week 57 Number Analyzed 26 participants 69 participants
-2.99  (23.42) -4.99  (22.99)
Dyspnoea: Week 60 Number Analyzed 19 participants 56 participants
-11.11  (23.42) -0.40  (22.32)
Dyspnoea: Week 63 Number Analyzed 13 participants 39 participants
-6.84  (15.41) -6.55  (23.04)
Dyspnoea: Week 66 Number Analyzed 7 participants 37 participants
-9.52  (16.27) -4.50  (21.98)
Dyspnoea: Week 69 Number Analyzed 6 participants 28 participants
-16.67  (21.94) -4.76  (23.12)
Dyspnoea: Week 72 Number Analyzed 8 participants 22 participants
-5.56  (19.70) -1.52  (24.56)
Dyspnoea: Week 75 Number Analyzed 5 participants 23 participants
-6.67  (14.91) -6.76  (17.64)
Dyspnoea: Week 78 Number Analyzed 2 participants 14 participants
0.00  (0.00) -3.17  (21.09)
Dyspnoea: Week 81 Number Analyzed 2 participants 9 participants
11.11  (15.71) -9.88  (22.53)
Dyspnoea: Week 84 Number Analyzed 2 participants 8 participants
0.00  (0.00) -6.94  (22.17)
Dyspnoea: Week 87 Number Analyzed 1 participants 4 participants
0.00 -2.78  (18.98)
Dyspnoea: Week 90 Number Analyzed 1 participants 2 participants
0.00 5.56  (23.57)
Dyspnoea: Week 93 Number Analyzed 0 participants 1 participants
22.22 [1]   (NA)
Dyspnoea: Time of First PD Number Analyzed 61 participants 70 participants
2.37  (22.05) -0.16  (24.48)
Dyspnoea: Time of Last Tx Dose Number Analyzed 199 participants 201 participants
3.96  (22.74) 0.44  (21.83)
Dyspnoea: Survival Follow-Up Week 12 Number Analyzed 28 participants 24 participants
9.92  (25.90) 13.43  (33.73)
Dyspnoea: Survival Follow-Up Week 24 Number Analyzed 19 participants 7 participants
4.68  (17.50) 4.76  (23.00)
Pain In Chest: Week 3 Number Analyzed 213 participants 205 participants
-1.25  (21.19) 0.81  (23.67)
Pain In Chest: Week 6 Number Analyzed 187 participants 190 participants
0.71  (25.15) -6.32  (24.39)
Pain In Chest: Week 9 Number Analyzed 162 participants 173 participants
0.82  (24.63) -4.24  (25.57)
Pain In Chest: Week 12 Number Analyzed 145 participants 168 participants
-2.07  (24.60) -0.60  (27.65)
Pain In Chest: Week 15 Number Analyzed 137 participants 159 participants
-1.46  (24.88) -3.56  (25.60)
Pain In Chest: Week 18 Number Analyzed 125 participants 149 participants
-3.47  (26.38) -3.36  (26.77)
Pain In Chest: Week 21 Number Analyzed 100 participants 146 participants
-3.33  (26.17) -2.74  (25.22)
Pain In Chest: Week 24 Number Analyzed 97 participants 133 participants
-2.41  (26.89) -4.76  (29.05)
Pain In Chest: Week 27 Number Analyzed 78 participants 123 participants
-5.13  (29.95) -2.71  (22.82)
Pain In Chest: Week 30 Number Analyzed 80 participants 120 participants
-4.17  (29.71) -3.06  (27.33)
Pain In Chest: Week 33 Number Analyzed 72 participants 103 participants
-0.46  (29.86) -3.88  (28.12)
Pain In Chest: Week 36 Number Analyzed 60 participants 103 participants
-1.67  (31.55) -2.91  (27.26)
Pain In Chest: Week 39 Number Analyzed 60 participants 92 participants
-3.89  (30.12) -3.99  (27.44)
Pain In Chest: Week 42 Number Analyzed 52 participants 93 participants
-7.69  (29.24) -7.17  (26.40)
Pain In Chest: Week 45 Number Analyzed 48 participants 77 participants
-6.25  (29.70) -5.63  (25.02)
Pain In Chest: Week 48 Number Analyzed 39 participants 79 participants
-7.69  (29.08) -4.64  (24.88)
Pain In Chest: Week 51 Number Analyzed 36 participants 79 participants
-11.11  (28.73) -5.49  (24.13)
Pain In Chest: Week 54 Number Analyzed 31 participants 70 participants
-7.53  (29.45) -4.29  (25.33)
Pain In Chest: Week 57 Number Analyzed 26 participants 69 participants
-1.28  (31.95) -5.80  (26.17)
Pain In Chest: Week 60 Number Analyzed 19 participants 56 participants
0.00  (22.22) -3.57  (27.47)
Pain In Chest: Week 63 Number Analyzed 13 participants 39 participants
-5.13  (18.49) -6.84  (25.57)
Pain In Chest: Week 66 Number Analyzed 7 participants 37 participants
-4.76  (23.00) -4.50  (27.40)
Pain In Chest: Week 69 Number Analyzed 6 participants 28 participants
-16.67  (18.26) -5.95  (31.50)
Pain In Chest: Week 72 Number Analyzed 8 participants 22 participants
-8.33  (23.57) -4.55  (23.67)
Pain In Chest: Week 75 Number Analyzed 5 participants 23 participants
-6.67  (14.91) 0.00  (20.10)
Pain In Chest: Week 78 Number Analyzed 2 participants 14 participants
0.00  (0.00) 0.00  (26.15)
Pain In Chest: Week 81 Number Analyzed 2 participants 9 participants
0.00  (47.14) 7.41  (14.70)
Pain In Chest: Week 84 Number Analyzed 2 participants 8 participants
0.00  (0.00) 4.17  (21.36)
Pain In Chest: Week 87 Number Analyzed 1 participants 4 participants
-33.33 [1]   (NA) 8.33  (16.67)
Pain In Chest: Week 90 Number Analyzed 1 participants 2 participants
-33.33 [1]   (NA) 0.00  (0.00)
Pain In Chest: Week 93 Number Analyzed 0 participants 1 participants
0.00
Pain In Chest: Time of First Pd Number Analyzed 61 participants 70 participants
6.56  (22.62) -3.81  (29.24)
Pain In Chest: Time of Last Tx Dose Number Analyzed 199 participants 201 participants
1.34  (25.26) -0.83  (26.96)
Pain In Chest: Survival Follow-Up Week 12 Number Analyzed 28 participants 24 participants
5.95  (36.35) -2.78  (32.48)
Pain In Chest: Survival Follow-Up Week 24 Number Analyzed 19 participants 7 participants
1.75  (17.48) -4.76  (29.99)
Pain In Arm Or Shoulder: Week 3 Number Analyzed 213 participants 205 participants
-4.69  (25.26) -2.60  (24.78)
Pain In Arm Or Shoulder: Week 6 Number Analyzed 187 participants 190 participants
-4.46  (23.14) -5.44  (25.19)
Pain In Arm Or Shoulder: Week 9 Number Analyzed 162 participants 173 participants
-2.88  (25.85) -8.09  (28.73)
Pain In Arm Or Shoulder: Week 12 Number Analyzed 145 participants 168 participants
-6.90  (23.54) -4.37  (27.19)
Pain In Arm Or Shoulder: Week 15 Number Analyzed 137 participants 159 participants
-3.89  (23.24) -7.34  (30.15)
Pain In Arm Or Shoulder: Week 18 Number Analyzed 125 participants 149 participants
-5.07  (25.77) -6.26  (29.09)
Pain In Arm Or Shoulder: Week 21 Number Analyzed 100 participants 146 participants
-6.00  (21.91) -1.83  (28.71)
Pain In Arm Or Shoulder: Week 24 Number Analyzed 97 participants 133 participants
-2.41  (28.16) -5.26  (30.11)
Pain In Arm Or Shoulder: Week 27 Number Analyzed 78 participants 123 participants
-5.56  (28.13) -3.79  (26.72)
Pain In Arm Or Shoulder: Week 30 Number Analyzed 80 participants 120 participants
1.25  (27.27) -3.33  (29.12)
Pain In Arm Or Shoulder: Week 33 Number Analyzed 72 participants 103 participants
-5.56  (25.02) -1.94  (27.54)
Pain In Arm Or Shoulder: Week 36 Number Analyzed 60 participants 103 participants
-1.67  (30.33) -3.24  (31.49)
Pain In Arm Or Shoulder: Week 39 Number Analyzed 60 participants 92 participants
-5.00  (30.58) -3.99  (30.80)
Pain In Arm Or Shoulder: Week 42 Number Analyzed 52 participants 93 participants
0.00  (28.77) -8.60  (25.49)
Pain In Arm Or Shoulder: Week 45 Number Analyzed 48 participants 77 participants
-0.69  (27.06) -6.06  (28.47)
Pain In Arm Or Shoulder: Week 48 Number Analyzed 39 participants 79 participants
-1.71  (27.52) -4.22  (29.89)
Pain In Arm Or Shoulder: Week 51 Number Analyzed 36 participants 79 participants
-2.78  (25.67) -3.38  (27.53)
Pain In Arm Or Shoulder: Week 54 Number Analyzed 31 participants 70 participants
-1.08  (21.92) -6.19  (25.56)
Pain In Arm Or Shoulder: Week 57 Number Analyzed 26 participants 69 participants
-1.28  (22.07) -2.90  (26.65)
Pain In Arm Or Shoulder: Week 60 Number Analyzed 19 participants 56 participants
-5.26  (20.07) -4.17  (27.75)
Pain In Arm Or Shoulder: Week 63 Number Analyzed 13 participants 39 participants
-5.13  (18.49) -3.42  (27.35)
Pain In Arm Or Shoulder: Week 66 Number Analyzed 7 participants 37 participants
4.76  (12.60) -1.80  (31.37)
Pain In Arm Or Shoulder: Week 69 Number Analyzed 6 participants 28 participants
0.00  (0.00) -7.14  (22.87)
Pain In Arm Or Shoulder: Week 72 Number Analyzed 8 participants 22 participants
-8.33  (15.43) -7.58  (27.08)
Pain In Arm Or Shoulder: Week 75 Number Analyzed 5 participants 23 participants
-6.67  (14.91) -8.70  (25.06)
Pain In Arm Or Shoulder: Week 78 Number Analyzed 2 participants 14 participants
0.00  (0.00) -2.38  (24.33)
Pain In Arm Or Shoulder: Week 81 Number Analyzed 2 participants 9 participants
0.00  (0.00) 3.70  (11.11)
Pain In Arm Or Shoulder: Week 84 Number Analyzed 2 participants 8 participants
0.00  (0.00) 4.17  (21.36)
Pain In Arm Or Shoulder: Week 87 Number Analyzed 1 participants 4 participants
0.00 [1]   (NA) -16.67  (33.33)
Pain In Arm Or Shoulder: Week 90 Number Analyzed 1 participants 2 participants
0.00 [1]   (NA) 0.00  (0.00)
Pain In Arm Or Shoulder: Week 93 Number Analyzed 0 participants 1 participants
0.00 [1]   (NA)
Pain In Arm Or Shoulder: Time of First Pd Number Analyzed 61 participants 70 participants
2.19  (28.46) 1.90  (25.94)
Pain In Arm Or Shoulder: Time of Last Tx Dose Number Analyzed 199 participants 201 participants
-0.50  (27.11) 0.33  (30.55)
Pain In Arm Or Shoulder:Survival Follow-Up Week 12 Number Analyzed 28 participants 24 participants
13.10  (30.55) 5.56  (40.13)
Pain In Arm Or Shoulder:Survival Follow-Up Week 24 Number Analyzed 19 participants 7 participants
1.75  (28.27) 0.00  (0.00)
[1]
Only 1 participant.
9.Secondary Outcome
Title Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score
Hide Description Change from baseline per SILC scale will be analyzed for each lung cancer symptoms scores. SILC questionnaire comprises 3 individual symptoms & are scored at individual symptom level, thus have a dyspnea score, chest pain score, & cough score. There are a total of 9 questions in SILC questionnaire, each question has a minimum value of 0 & maximum value of 4. Each individual symptom score is calculated as average of responses for symptom items. 'Chest pain' score is mean of question 1 & 2, 'Cough' score is mean of question 3 & 4 and 'Dyspnea' score is mean of question 5 to 9 in SILC questionnaire. An increase in score is suggestive of a worsening in symptomology. A score change of ≥0.3 points for dyspnea & cough symptom scores is considered to be clinically significant; whereas a score change of≥0.5 points for chest pain score is considered to be clinically significant.
Time Frame Baseline up to 3 and 6 months after disease progression or loss of clinical benefit (up to approximately 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with a non-missing baseline and at least a post-baseline PRO assessment (i.e., PRO evaluable population).
Arm/Group Title Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who did not experience disease progression during the induction phase began maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 176 200
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Chest Pain: Week 1 Number Analyzed 160 participants 186 participants
0.20  (0.83) 0.30  (0.88)
Chest Pain: Week 2 Number Analyzed 152 participants 176 participants
-0.01  (0.88) 0.21  (0.85)
Chest Pain: Week 3 Number Analyzed 151 participants 165 participants
-0.05  (0.92) 0.06  (0.95)
Chest Pain: Week 4 Number Analyzed 144 participants 160 participants
0.03  (0.91) 0.03  (0.93)
Chest Pain: Week 5 Number Analyzed 143 participants 166 participants
-0.02  (0.93) -0.01  (0.88)
Chest Pain: Week 6 Number Analyzed 132 participants 166 participants
-0.05  (0.88) -0.02  (0.92)
Chest Pain: Week 7 Number Analyzed 132 participants 156 participants
0.07  (1.00) -0.04  (1.00)
Chest Pain: Week 8 Number Analyzed 124 participants 157 participants
0.03  (0.94) -0.07  (1.02)
Chest Pain: Week 9 Number Analyzed 125 participants 159 participants
0.06  (1.00) -0.03  (1.03)
Chest Pain: Week 10 Number Analyzed 120 participants 152 participants
0.03  (1.02) 0.02  (1.05)
Chest Pain: Week 11 Number Analyzed 117 participants 156 participants
0.02  (0.96) 0.04  (1.09)
Chest Pain: Week 12 Number Analyzed 116 participants 142 participants
-0.02  (0.96) -0.01  (1.02)
Chest Pain: Week 13 Number Analyzed 108 participants 142 participants
-0.05  (1.02) 0.05  (0.97)
Chest Pain: Week 14 Number Analyzed 103 participants 132 participants
-0.07  (1.12) 0.06  (1.06)
Chest Pain: Week 15 Number Analyzed 101 participants 133 participants
0.13  (1.16) 0.08  (0.94)
Chest Pain: Week 16 Number Analyzed 100 participants 133 participants
0.02  (1.08) 0.08  (1.04)
Chest Pain: Week 17 Number Analyzed 97 participants 131 participants
0.02  (1.08) 0.00  (1.08)
Chest Pain: Week 18 Number Analyzed 88 participants 121 participants
-0.06  (1.11) 0.12  (1.07)
Chest Pain: Week 19 Number Analyzed 81 participants 122 participants
-0.15  (1.12) 0.02  (1.01)
Chest Pain: Week 20 Number Analyzed 71 participants 112 participants
-0.02  (1.22) -0.01  (1.03)
Chest Pain: Week 21 Number Analyzed 74 participants 114 participants
0.03  (1.28) 0.01  (1.03)
Chest Pain: Week 22 Number Analyzed 65 participants 106 participants
0.04  (1.21) 0.02  (1.02)
Chest Pain: Week 23 Number Analyzed 65 participants 106 participants
-0.08  (1.14) 0.04  (0.96)
Chest Pain: Week 24 Number Analyzed 64 participants 106 participants
-0.02  (1.16) 0.09  (0.99)
Chest Pain: Week 25 Number Analyzed 60 participants 100 participants
0.05  (1.24) 0.14  (1.03)
Chest Pain: Week 26 Number Analyzed 55 participants 100 participants
-0.05  (1.14) 0.09  (1.00)
Chest Pain: Week 27 Number Analyzed 55 participants 99 participants
0.04  (1.17) 0.04  (1.01)
Chest Pain: Week 28 Number Analyzed 55 participants 96 participants
0.24  (1.18) 0.03  (0.93)
Chest Pain: Week 29 Number Analyzed 54 participants 99 participants
0.06  (1.29) 0.04  (0.95)
Chest Pain: Week 30 Number Analyzed 52 participants 95 participants
0.01  (1.37) 0.04  (0.97)
Chest Pain: Week 31 Number Analyzed 44 participants 93 participants
0.02  (1.09) 0.05  (0.88)
Chest Pain: Week 32 Number Analyzed 39 participants 94 participants
0.21  (1.21) -0.01  (0.98)
Chest Pain: Week 33 Number Analyzed 41 participants 85 participants
0.04  (1.17) 0.03  (0.92)
Chest Pain: Week 34 Number Analyzed 40 participants 84 participants
0.21  (1.27) 0.11  (0.99)
Chest Pain: Week 35 Number Analyzed 39 participants 87 participants
0.33  (1.30) 0.11  (0.98)
Chest Pain: Week 36 Number Analyzed 34 participants 86 participants
0.15  (1.07) 0.17  (1.04)
Chest Pain: Week 37 Number Analyzed 33 participants 86 participants
0.15  (1.21) 0.06  (0.94)
Chest Pain: Week 38 Number Analyzed 30 participants 80 participants
0.12  (1.16) 0.04  (1.03)
Chest Pain: Week 39 Number Analyzed 32 participants 72 participants
0.20  (1.23) 0.13  (1.01)
Chest Pain: Week 40 Number Analyzed 31 participants 77 participants
0.15  (1.31) 0.04  (0.96)
Chest Pain: Week 41 Number Analyzed 30 participants 74 participants
-0.05  (1.06) 0.09  (1.03)
Chest Pain: Week 42 Number Analyzed 27 participants 73 participants
-0.06  (1.07) 0.03  (1.02)
Chest Pain: Week 43 Number Analyzed 23 participants 76 participants
-0.22  (0.82) 0.13  (1.02)
Chest Pain: Week 44 Number Analyzed 25 participants 72 participants
-0.10  (1.29) 0.10  (1.04)
Chest Pain: Week 45 Number Analyzed 25 participants 69 participants
-0.20  (1.24) 0.03  (0.95)
Chest Pain: Week 46 Number Analyzed 24 participants 67 participants
-0.06  (1.18) 0.08  (0.99)
Chest Pain: Week 47 Number Analyzed 23 participants 63 participants
0.02  (1.09) 0.09  (0.91)
Chest Pain: Week 48 Number Analyzed 25 participants 64 participants
0.02  (1.27) 0.05  (1.00)
Chest Pain: Week 49 Number Analyzed 23 participants 62 participants
-0.09  (1.07) 0.03  (0.90)
Chest Pain: Week 50 Number Analyzed 23 participants 58 participants
-0.13  (0.99) 0.00  (1.03)
Chest Pain: Week 51 Number Analyzed 21 participants 62 participants
-0.02  (0.77) 0.12  (0.94)
Chest Pain: Week 52 Number Analyzed 21 participants 55 participants
0.14  (1.06) 0.00  (1.11)
Chest Pain: Week 53 Number Analyzed 23 participants 54 participants
0.13  (1.35) -0.01  (1.06)
Chest Pain: Week 54 Number Analyzed 22 participants 54 participants
0.11  (1.16) -0.08  (1.10)
Chest Pain: Week 55 Number Analyzed 21 participants 49 participants
0.12  (1.38) 0.03  (1.14)
Chest Pain: Week 56 Number Analyzed 20 participants 53 participants
0.13  (1.46) 0.04  (1.18)
Chest Pain: Week 57 Number Analyzed 17 participants 46 participants
0.12  (1.21) -0.01  (1.15)
Chest Pain: Week 58 Number Analyzed 15 participants 43 participants
0.27  (0.98) -0.12  (1.10)
Chest Pain: Week 59 Number Analyzed 13 participants 40 participants
0.23  (0.73) -0.23  (1.01)
Chest Pain: Week 60 Number Analyzed 11 participants 41 participants
0.14  (0.67) -0.15  (1.17)
Chest Pain: Week 61 Number Analyzed 13 participants 43 participants
0.23  (0.83) 0.00  (1.06)
Chest Pain: Week 62 Number Analyzed 13 participants 37 participants
0.46  (0.72) -0.04  (1.08)
Chest Pain: Week 63 Number Analyzed 12 participants 36 participants
0.25  (0.75) -0.06  (1.09)
Chest Pain: Week 64 Number Analyzed 10 participants 35 participants
0.15  (0.78) 0.09  (0.95)
Chest Pain: Week 65 Number Analyzed 9 participants 33 participants
0.11  (0.82) -0.03  (0.99)
Chest Pain: Week 66 Number Analyzed 6 participants 34 participants
0.42  (0.92) 0.13  (1.05)
Chest Pain: Week 67 Number Analyzed 7 participants 30 participants
0.36  (0.85) 0.02  (1.00)
Chest Pain: Week 68 Number Analyzed 6 participants 30 participants
0.33  (0.88) 0.12  (1.18)
Chest Pain: Week 69 Number Analyzed 7 participants 29 participants
0.07  (0.93) -0.05  (1.10)
Chest Pain: Week 70 Number Analyzed 6 participants 30 participants
0.25  (0.88) 0.03  (1.11)
Chest Pain: Week 71 Number Analyzed 5 participants 26 participants
0.30  (0.97) 0.04  (1.09)
Chest Pain: Week 72 Number Analyzed 4 participants 25 participants
-0.13  (0.25) -0.22  (0.94)
Chest Pain: Week 73 Number Analyzed 4 participants 24 participants
0.13  (1.31) -0.10  (1.01)
Chest Pain: Week 74 Number Analyzed 4 participants 23 participants
0.38  (1.11) -0.02  (1.14)
Chest Pain: Week 75 Number Analyzed 4 participants 21 participants
0.38  (1.11) -0.07  (1.14)
Chest Pain: Week 76 Number Analyzed 3 participants 17 participants
0.00  (0.50) -0.06  (1.20)
Chest Pain: Week 77 Number Analyzed 2 participants 17 participants
-0.25  (0.35) -0.21  (1.03)
Chest Pain: Week 78 Number Analyzed 2 participants 14 participants
-0.75  (0.35) -0.25  (1.14)
Chest Pain: Week 79 Number Analyzed 2 participants 14 participants
0.00  (0.71) -0.18  (1.20)
Chest Pain: Week 80 Number Analyzed 2 participants 13 participants
-0.25  (0.35) -0.12  (0.96)
Chest Pain: Week 81 Number Analyzed 2 participants 12 participants
-0.25  (0.35) -0.25  (0.89)
Chest Pain: Week 82 Number Analyzed 2 participants 9 participants
-0.75  (0.35) 0.00  (1.25)
Chest Pain: Week 83 Number Analyzed 2 participants 4 participants
-0.25  (0.35) -0.50  (1.73)
Chest Pain: Week 84 Number Analyzed 2 participants 5 participants
0.00  (0.71) -0.30  (1.57)
Chest Pain: Week 85 Number Analyzed 1 participants 5 participants
-1.00 [1]   (NA) -0.20  (1.68)
Chest Pain: Week 86 Number Analyzed 1 participants 4 participants
0.00 [1]   (NA) -0.50  (1.73)
Chest Pain: Week 87 Number Analyzed 1 participants 3 participants
-1.00 [1]   (NA) 0.50  (0.87)
Chest Pain: Week 88 Number Analyzed 1 participants 4 participants
-1.00 [1]   (NA) 0.00  (0.00)
Chest Pain: Week 89 Number Analyzed 1 participants 2 participants
-1.00 [1]   (NA) 0.00  (0.00)
Chest Pain: Week 90 Number Analyzed 1 participants 2 participants
0.00 [1]   (NA) 0.00  (0.00)
Chest Pain: Week 91 Number Analyzed 1 participants 2 participants
0.00 [1]   (NA) 0.00  (0.00)
Chest Pain: Week 92 Number Analyzed 0 participants 2 participants
0.00  (0.00)
Chest Pain: Week 93 Number Analyzed 0 participants 2 participants
0.00  (0.00)
Chest Pain: Week 94 Number Analyzed 0 participants 1 participants
1.00 [1]   (NA)
Chest Pain: Week 95 Number Analyzed 0 participants 1 participants
0.50 [1]   (NA)
Chest Pain: Time of First Pd Number Analyzed 110 participants 96 participants
0.28  (1.06) 0.20  (0.91)
Chest Pain: Time of Last Tx Dose Number Analyzed 141 participants 150 participants
0.17  (1.17) 0.13  (0.98)
Cough: Week 1 Number Analyzed 160 participants 186 participants
-0.08  (0.74) -0.06  (0.89)
Cough: Week 2 Number Analyzed 152 participants 176 participants
-0.13  (0.73) -0.08  (0.90)
Cough: Week 3 Number Analyzed 151 participants 165 participants
-0.05  (0.77) -0.07  (0.81)
Cough: Week 4 Number Analyzed 144 participants 160 participants
-0.11  (0.89) -0.22  (0.85)
Cough: Week 5 Number Analyzed 143 participants 166 participants
-0.14  (0.83) -0.33  (0.89)
Cough: Week 6 Number Analyzed 132 participants 166 participants
-0.16  (0.85) -0.33  (0.91)
Cough: Week 7 Number Analyzed 132 participants 156 participants
-0.22  (0.89) -0.22  (0.97)
Cough: Week 8 Number Analyzed 124 participants 157 participants
-0.20  (0.89) -0.28  (0.98)
Cough: Week 9 Number Analyzed 125 participants 159 participants
-0.17  (0.91) -0.29  (0.97)
Cough: Week 10 Number Analyzed 120 participants 152 participants
-0.22  (0.95) -0.35  (1.06)
Cough: Week 11 Number Analyzed 117 participants 156 participants
-0.21  (0.99) -0.33  (1.02)
Cough: Week 12 Number Analyzed 116 participants 142 participants
-0.13  (1.05) -0.40  (0.96)
Cough: Week 13 Number Analyzed 108 participants 142 participants
-0.24  (1.05) -0.37  (1.04)
Cough: Week 14 Number Analyzed 103 participants 132 participants
-0.23  (0.98) -0.34  (1.03)
Cough: Week 15 Number Analyzed 101 participants 133 participants
-0.11  (1.03) -0.33  (1.03)
Cough: Week 16 Number Analyzed 100 participants 133 participants
-0.20  (1.05) -0.33  (1.04)
Cough: Week 17 Number Analyzed 97 participants 131 participants
-0.20  (1.11) -0.31  (0.99)
Cough: Week 18 Number Analyzed 88 participants 121 participants
-0.19  (1.12) -0.31  (1.00)
Cough: Week 19 Number Analyzed 81 participants 122 participants
-0.25  (1.07) -0.36  (1.06)
Cough: Week 20 Number Analyzed 71 participants 112 participants
-0.25  (1.16) -0.39  (0.99)
Cough: Week 21 Number Analyzed 74 participants 114 participants
-0.19  (1.09) -0.36  (1.07)
Cough: Week 22 Number Analyzed 65 participants 106 participants
-0.29  (1.11) -0.41  (1.08)
Cough: Week 23 Number Analyzed 65 participants 106 participants
-0.34  (1.07) -0.44  (1.04)
Cough: Week 24 Number Analyzed 64 participants 106 participants
-0.27  (0.96) -0.29  (1.13)
Cough: Week 25 Number Analyzed 60 participants 100 participants
-0.24  (1.11) -0.27  (1.10)
Cough: Week 26 Number Analyzed 55 participants 100 participants
-0.25  (1.16) -0.22  (1.22)
Cough: Week 27 Number Analyzed 55 participants 99 participants
-0.19  (0.99) -0.32  (1.11)
Cough: Week 28 Number Analyzed 55 participants 96 participants
-0.19  (1.04) -0.32  (1.12)
Cough: Week 29 Number Analyzed 54 participants 99 participants
-0.25  (1.13) -0.34  (1.11)
Cough: Week 30 Number Analyzed 52 participants 95 participants
-0.08  (1.12) -0.34  (1.00)
Cough: Week 31 Number Analyzed 44 participants 93 participants
-0.13  (1.13) -0.37  (0.99)
Cough: Week 32 Number Analyzed 39 participants 94 participants
0.01  (1.09) -0.45  (0.94)
Cough: Week 33 Number Analyzed 41 participants 85 participants
0.05  (1.17) -0.44  (0.99)
Cough: Week 34 Number Analyzed 40 participants 84 participants
-0.10  (1.09) -0.29  (1.02)
Cough: Week 35 Number Analyzed 39 participants 87 participants
-0.27  (1.05) -0.32  (0.99)
Cough: Week 36 Number Analyzed 34 participants 86 participants
0.01  (1.10) -0.31  (0.99)
Cough: Week 37 Number Analyzed 33 participants 86 participants
-0.11  (1.16) -0.37  (1.01)
Cough: Week 38 Number Analyzed 30 participants 80 participants
0.02  (1.03) -0.31  (1.03)
Cough: Week 39 Number Analyzed 32 participants 72 participants
0.02  (1.19) -0.33  (0.98)
Cough: Week 40 Number Analyzed 31 participants 77 participants
-0.10  (1.15) -0.35  (1.07)
Cough: Week 41 Number Analyzed 30 participants 74 participants
-0.27  (1.10) -0.30  (1.09)
Cough: Week 42 Number Analyzed 27 participants 73 participants
-0.31  (1.04) -0.31  (1.04)
Cough: Week 43 Number Analyzed 23 participants 76 participants
-0.20  (1.04) -0.37  (0.98)
Cough: Week 44 Number Analyzed 25 participants 72 participants
0.00  (1.04) -0.36  (1.03)
Cough: Week 45 Number Analyzed 25 participants 69 participants
-0.18  (1.14) -0.41  (1.04)
Cough: Week 46 Number Analyzed 24 participants 67 participants
-0.25  (1.04) -0.34  (1.17)
Cough: Week 47 Number Analyzed 23 participants 63 participants
-0.43  (1.09) -0.29  (1.17)
Cough: Week 48 Number Analyzed 25 participants 64 participants
-0.26  (1.16) -0.38  (1.08)
Cough: Week 49 Number Analyzed 23 participants 62 participants
-0.50  (1.07) -0.40  (1.10)
Cough: Week 50 Number Analyzed 23 participants 58 participants
-0.37  (0.84) -0.40  (1.06)
Cough: Week 51 Number Analyzed 21 participants 62 participants
-0.45  (1.16) -0.15  (1.10)
Cough: Week 52 Number Analyzed 21 participants 55 participants
-0.29  (1.07) -0.10  (1.17)
Cough: Week 53 Number Analyzed 23 participants 54 participants
-0.24  (1.21) -0.13  (1.17)
Cough: Week 54 Number Analyzed 22 participants 54 participants
-0.27  (1.10) -0.16  (1.15)
Cough: Week 55 Number Analyzed 21 participants 49 participants
-0.10  (1.15) -0.35  (1.13)
Cough: Week 56 Number Analyzed 20 participants 53 participants
-0.30  (1.14) -0.26  (1.17)
Cough: Week 57 Number Analyzed 17 participants 46 participants
-0.41  (0.92) -0.25  (1.10)
Cough: Week 58 Number Analyzed 15 participants 43 participants
-0.17  (1.05) -0.45  (0.96)
Cough: Week 59 Number Analyzed 13 participants 40 participants
-0.31  (0.93) -0.50  (1.02)
Cough: Week 60 Number Analyzed 11 participants 41 participants
-0.55  (1.04) -0.52  (1.03)
Cough: Week 61 Number Analyzed 13 participants 43 participants
-0.23  (1.15) -0.38  (1.07)
Cough: Week 62 Number Analyzed 13 participants 37 participants
0.04  (1.03) -0.53  (1.15)
Cough: Week 63 Number Analyzed 12 participants 36 participants
-0.29  (1.18) -0.57  (1.10)
Cough: Week 64 Number Analyzed 10 participants 35 participants
-0.45  (1.04) -0.49  (1.01)
Cough: Week 65 Number Analyzed 9 participants 33 participants
-0.61  (0.96) -0.39  (0.94)
Cough: Week 66 Number Analyzed 6 participants 34 participants
-0.17  (0.82) -0.43  (1.18)
Cough: Week 67 Number Analyzed 7 participants 30 participants
-0.64  (1.07) -0.47  (0.84)
Cough: Week 68 Number Analyzed 6 participants 30 participants
-0.75  (0.88) -0.35  (1.04)
Cough: Week 69 Number Analyzed 7 participants 29 participants
-0.57  (1.10) -0.53  (0.90)
Cough: Week 70 Number Analyzed 6 participants 30 participants
-0.83  (0.93) -0.43  (0.98)
Cough: Week 71 Number Analyzed 5 participants 26 participants
-0.90  (0.89) -0.56  (1.04)
Cough: Week 72 Number Analyzed 4 participants 25 participants
-1.25  (0.50) -0.72  (1.15)
Cough: Week 73 Number Analyzed 4 participants 24 participants
-0.63  (1.11) -0.77  (1.00)
Cough: Week 74 Number Analyzed 4 participants 23 participants
-0.63  (1.11) -0.54  (0.94)
Cough: Week 75 Number Analyzed 4 participants 21 participants
-0.63  (1.11) -0.67  (1.00)
Cough: Week 76 Number Analyzed 3 participants 17 participants
-1.00  (1.00) -0.65  (1.22)
Cough: Week 77 Number Analyzed 2 participants 17 participants
-0.50  (0.71) -0.82  (1.21)
Cough: Week 78 Number Analyzed 2 participants 14 participants
-1.00  (0.00) -0.57  (1.04)
Cough: Week 79 Number Analyzed 2 participants 14 participants
-0.25  (0.35) -0.64  (1.23)
Cough: Week 80 Number Analyzed 2 participants 13 participants
-0.50  (0.71) -1.04  (1.11)
Cough: Week 81 Number Analyzed 2 participants 12 participants
-0.50  (0.71) -0.79  (1.05)
Cough: Week 82 Number Analyzed 2 participants 9 participants
-0.50  (0.71) -0.89  (1.27)
Cough: Week 83 Number Analyzed 2 participants 4 participants
-1.00  (0.00) 0.13  (1.03)
Cough: Week 84 Number Analyzed 2 participants 5 participants
-0.50  (0.71) -0.20  (1.04)
Cough: Week 85 Number Analyzed 1 participants 5 participants
0.00 [1]   (NA) 0.00  (0.87)
Cough: Week 86 Number Analyzed 1 participants 4 participants
0.00 [1]   (NA) -0.38  (0.48)
Cough: Week 87 Number Analyzed 1 participants 3 participants
0.00 [1]   (NA) -0.83  (0.58)
Cough: Week 88 Number Analyzed 1 participants 4 participants
0.00 [1]   (NA) -0.88  (0.48)
Cough: Week 89 Number Analyzed 1 participants 2 participants
0.00 0.00  (0.71)
Cough: Week 90 Number Analyzed 1 participants 2 participants
0.00 0.25  (1.06)
Cough: Week 91 Number Analyzed 1 participants 2 participants
0.00 -0.50  (0.00)
Cough: Week 92 Number Analyzed 0 participants 2 participants
0.50  (0.71)
Cough: Week 93 Number Analyzed 0 participants 2 participants
0.50  (0.71)
Cough: Week 94 Number Analyzed 0 participants 1 participants
0.50 [1]   (NA)
Cough: Week 95 Number Analyzed 0 participants 1 participants
0.00 [1]   (NA)
Cough: Time of First Pd Number Analyzed 110 participants 96 participants
-0.08  (1.12) -0.45  (0.93)
Cough: Time of Last Tx Dose Number Analyzed 141 participants 150 participants
-0.15  (0.95) -0.29  (0.91)
Dyspnoea: Week 1 Number Analyzed 160 participants 186 participants
0.20  (0.82) 0.16  (0.81)
Dyspnoea: Week 2 Number Analyzed 152 participants 176 participants
0.11  (0.76) 0.15  (0.82)
Dyspnoea: Week 3 Number Analyzed 151 participants 165 participants
0.10  (0.71) 0.12  (0.70)
Dyspnoea: Week 4 Number Analyzed 144 participants 160 participants
0.21  (0.84) 0.17  (0.95)
Dyspnoea: Week 5 Number Analyzed 143 participants 166 participants
0.22  (0.82) 0.17  (0.91)
Dyspnoea: Week 6 Number Analyzed 132 participants 166 participants
0.23  (0.82) 0.16  (0.95)
Dyspnoea: Week 7 Number Analyzed 132 participants 156 participants
0.30  (0.93) 0.25  (0.92)
Dyspnoea: Week 8 Number Analyzed 124 participants 157 participants
0.35  (0.87) 0.24  (0.96)
Dyspnoea: Week 9 Number Analyzed 125 participants 159 participants
0.34  (0.89) 0.17  (0.91)
Dyspnoea: Week 10 Number Analyzed 120 participants 152 participants
0.46  (0.93) 0.16  (0.92)
Dyspnoea: Week 11 Number Analyzed 117 participants 156 participants
0.39  (1.01) 0.26  (0.96)
Dyspnoea: Week 12 Number Analyzed 116 participants 142 participants
0.38  (0.96) 0.22  (0.90)
Dyspnoea: Week 13 Number Analyzed 108 participants 142 participants
0.34  (0.96) 0.30  (1.02)
Dyspnoea: Week 14 Number Analyzed 103 participants 132 participants
0.44  (0.95) 0.22  (0.99)
Dyspnoea: Week 15 Number Analyzed 101 participants 133 participants
0.45  (0.94) 0.19  (0.95)
Dyspnoea: Week 16 Number Analyzed 100 participants 133 participants
0.37  (1.06) 0.26  (1.02)
Dyspnoea: Week 17 Number Analyzed 97 participants 131 participants
0.35  (1.04) 0.15  (1.00)
Dyspnoea: Week 18 Number Analyzed 88 participants 121 participants
0.35  (0.99) 0.22  (0.99)
Dyspnoea: Week 19 Number Analyzed 81 participants 122 participants
0.30  (1.02) 0.22  (0.97)
Dyspnoea: Week 20 Number Analyzed 71 participants 112 participants
0.30  (1.09) 0.27  (1.06)
Dyspnoea: Week 21 Number Analyzed 74 participants 114 participants
0.22  (1.03) 0.22  (1.05)
Dyspnoea: Week 22 Number Analyzed 65 participants 106 participants
0.16  (1.10) 0.28  (1.03)
Dyspnoea: Week 23 Number Analyzed 65 participants 106 participants
0.24  (1.05) 0.22  (1.03)
Dyspnoea: Week 24 Number Analyzed 64 participants 106 participants
0.30  (0.98) 0.24  (0.99)
Dyspnoea: Week 25 Number Analyzed 60 participants 100 participants
0.50  (1.05) 0.28  (0.99)
Dyspnoea: Week 26 Number Analyzed 55 participants 100 participants
0.30  (1.05) 0.24  (1.04)
Dyspnoea: Week 27 Number Analyzed 55 participants 99 participants
0.43  (1.17) 0.24  (1.06)
Dyspnoea: Week 28 Number Analyzed 55 participants 96 participants
0.46  (1.02) 0.25  (0.97)
Dyspnoea: Week 29 Number Analyzed 54 participants 99 participants
0.43  (1.06) 0.20  (1.01)
Dyspnoea: Week 30 Number Analyzed 52 participants 95 participants
0.45  (1.08) 0.21  (0.99)
Dyspnoea: Week 31 Number Analyzed 44 participants 93 participants
0.35  (1.03) 0.15  (0.99)
Dyspnoea: Week 32 Number Analyzed 39 participants 94 participants
0.48  (1.03) 0.16  (1.01)
Dyspnoea: Week 33 Number Analyzed 41 participants 85 participants
0.36  (0.96) 0.17  (0.95)
Dyspnoea: Week 34 Number Analyzed 40 participants 84 participants
0.47  (1.15) 0.24  (1.04)
Dyspnoea: Week 35 Number Analyzed 39 participants 87 participants
0.42  (1.00) 0.23  (1.03)
Dyspnoea: Week 36 Number Analyzed 34 participants 86 participants
0.59  (1.06) 0.22  (1.02)
Dyspnoea: Week 37 Number Analyzed 33 participants 86 participants
0.53  (1.17) 0.24  (1.03)
Dyspnoea: Week 38 Number Analyzed 30 participants 80 participants
0.59  (1.06) 0.22  (1.07)
Dyspnoea: Week 39 Number Analyzed 32 participants 72 participants
0.65  (1.04) 0.19  (1.01)
Dyspnoea: Week 40 Number Analyzed 31 participants 77 participants
0.62  (1.02) 0.19  (0.95)
Dyspnoea: Week 41 Number Analyzed 30 participants 74 participants
0.63  (1.01) 0.16  (0.95)
Dyspnoea: Week 42 Number Analyzed 27 participants 73 participants
0.50  (1.01) 0.17  (0.92)
Dyspnoea: Week 43 Number Analyzed 23 participants 76 participants
0.32  (0.89) 0.22  (0.90)
Dyspnoea: Week 44 Number Analyzed 25 participants 72 participants
0.58  (0.83) 0.23  (0.92)
Dyspnoea: Week 45 Number Analyzed 25 participants 69 participants
0.49  (0.96) 0.21  (0.90)
Dyspnoea: Week 46 Number Analyzed 24 participants 67 participants
0.55  (1.02) 0.23  (0.89)
Dyspnoea: Week 47 Number Analyzed 23 participants 63 participants
0.53  (1.09) 0.14  (0.90)
Dyspnoea: Week 48 Number Analyzed 25 participants 64 participants
0.55  (0.96) 0.14  (0.85)
Dyspnoea: Week 49 Number Analyzed 23 participants 62 participants
0.63  (1.04) 0.16  (0.90)
Dyspnoea: Week 50 Number Analyzed 23 participants 58 participants
0.52  (0.98) 0.24  (0.94)
Dyspnoea: Week 51 Number Analyzed 21 participants 62 participants
0.67  (1.04) 0.30  (0.97)
Dyspnoea: Week 52 Number Analyzed 21 participants 55 participants
0.72  (1.02) 0.27  (1.02)
Dyspnoea: Week 53 Number Analyzed 23 participants 54 participants
0.81  (1.06) 0.22  (0.95)
Dyspnoea: Week 54 Number Analyzed 22 participants 54 participants
0.82  (1.06) 0.23  (0.95)
Dyspnoea: Week 55 Number Analyzed 21 participants 49 participants
0.77  (1.17) 0.16  (0.99)
Dyspnoea: Week 56 Number Analyzed 20 participants 53 participants
0.84  (1.15) 0.18  (0.95)
Dyspnoea: Week 57 Number Analyzed 17 participants 46 participants
0.68  (1.16) 0.11  (0.91)
Dyspnoea: Week 58 Number Analyzed 15 participants 43 participants
0.77  (1.06) 0.16  (0.86)
Dyspnoea: Week 59 Number Analyzed 13 participants 40 participants
0.66  (0.90) 0.07  (0.85)
Dyspnoea: Week 60 Number Analyzed 11 participants 41 participants
0.73  (0.96) 0.27  (0.94)
Dyspnoea: Week 61 Number Analyzed 13 participants 43 participants
0.85  (1.04) 0.23  (0.90)
Dyspnoea: Week 62 Number Analyzed 13 participants 37 participants
0.95  (1.05) 0.16  (0.92)
Dyspnoea: Week 63 Number Analyzed 12 participants 36 participants
0.67  (1.01) 0.27  (0.95)
Dyspnoea: Week 64 Number Analyzed 10 participants 35 participants
0.46  (0.78) 0.14  (0.93)
Dyspnoea: Week 65 Number Analyzed 9 participants 33 participants
0.40  (0.66) 0.12  (0.95)
Dyspnoea: Week 66 Number Analyzed 6 participants 34 participants
0.67  (0.74) 0.16  (0.94)
Dyspnoea: Week 67 Number Analyzed 7 participants 30 participants
0.37  (0.76) 0.26  (1.01)
Dyspnoea: Week 68 Number Analyzed 6 participants 30 participants
0.47  (0.80) 0.25  (1.03)
Dyspnoea: Week 69 Number Analyzed 7 participants 29 participants
0.43  (0.80) 0.16  (1.11)
Dyspnoea: Week 70 Number Analyzed 6 participants 30 participants
0.33  (0.83) 0.07  (0.89)
Dyspnoea: Week 71 Number Analyzed 5 participants 26 participants
0.40  (0.91) 0.13  (0.89)
Dyspnoea: Week 72 Number Analyzed 4 participants 25 participants
-0.05  (0.25) 0.06  (0.91)
Dyspnoea: Week 73 Number Analyzed 4 participants 24 participants
0.45  (1.04) 0.09  (0.99)
Dyspnoea: Week 74 Number Analyzed 4 participants 23 participants
0.50  (1.01) 0.27  (1.19)
Dyspnoea: Week 75 Number Analyzed 4 participants 21 participants
0.55  (0.97) 0.45  (1.31)
Dyspnoea: Week 76 Number Analyzed 3 participants 17 participants
-0.07  (0.12) 0.02  (1.10)
Dyspnoea: Week 77 Number Analyzed 2 participants 17 participants
0.00  (0.00) 0.09  (1.17)
Dyspnoea: Week 78 Number Analyzed 2 participants 14 participants
0.00  (0.00) 0.03  (1.19)
Dyspnoea: Week 79 Number Analyzed 2 participants 14 participants
0.00  (0.00) 0.19  (1.18)
Dyspnoea: Week 80 Number Analyzed 2 participants 13 participants
0.10  (0.14) -0.26  (0.80)
Dyspnoea: Week 81 Number Analyzed 2 participants 12 participants
0.10  (0.14) -0.17  (1.15)
Dyspnoea: Week 82 Number Analyzed 2 participants 9 participants
0.00  (0.00) 0.18  (1.54)
Dyspnoea: Week 83 Number Analyzed 2 participants 4 participants
0.00  (0.00) 0.45  (1.22)
Dyspnoea: Week 84 Number Analyzed 2 participants 5 participants
0.00  (0.00) 0.60  (1.10)
Dyspnoea: Week 85 Number Analyzed 1 participants 5 participants
0.20 [1]   (NA) 0.32  (1.53)
Dyspnoea: Week 86 Number Analyzed 1 participants 4 participants
0.00 [1]   (NA) -0.15  (0.34)
Dyspnoea: Week 87 Number Analyzed 1 participants 3 participants
0.20 [1]   (NA) -0.47  (0.23)
Dyspnoea: Week 88 Number Analyzed 1 participants 4 participants
0.20 [1]   (NA) -0.70  (0.20)
Dyspnoea: Week 89 Number Analyzed 1 participants 2 participants
0.20 [1]   (NA) -0.20  (0.57)
Dyspnoea: Week 90 Number Analyzed 1 participants 2 participants
0.20 [1]   (NA) -0.50  (0.14)
Dyspnoea: Week 91 Number Analyzed 1 participants 2 participants
0.00 [1]   (NA) -0.50  (0.14)
Dyspnoea: Week 92 Number Analyzed 0 participants 2 participants
-0.70  (0.14)
Dyspnoea: Week 93 Number Analyzed 0 participants 2 participants
-0.40  (0.28)
Dyspnoea: Week 94 Number Analyzed 0 participants 1 participants
-0.80 [1]   (NA)
Dyspnoea: Week 95 Number Analyzed 0 participants 1 participants
-1.00 [1]   (NA)
Dyspnoea: Time of First Pd Number Analyzed 110 participants 96 participants
0.58  (0.99) 0.40  (1.06)
Dyspnoea: Time of Last Tx Dose Number Analyzed 141 participants 150 participants
0.47  (0.95) 0.18  (0.94)
[1]
Only 1 participant.
10.Secondary Outcome
Title Minimum Observed Serum Atezolizumab Concentration (Cmin)
Hide Description Minimum observed serum atezolizumab concentration (Cmin) prior to infusion at selected cycles (Arm A)
Time Frame Predose (Prd; 0 hour [h]) on D1 of Cy 2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle (up to approximately 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample.
Arm/Group Title Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 247
Mean (Standard Deviation)
Unit of Measure: μg/mL
Cy2D1 Number Analyzed 247 participants
69.8  (32.3)
Cy3D1 Number Analyzed 228 participants
115  (51.5)
Cy4D1 Number Analyzed 213 participants
151  (69.9)
Cy8D1 Number Analyzed 145 participants
221  (101)
Cy16D1 Number Analyzed 76 participants
234  (86.7)
Cy24D1 Number Analyzed 13 participants
257  (95.1)
Treatment Discontinuation Visit Number Analyzed 131 participants
129  (93.1)
Day 120 Post Last Dose Number Analyzed 55 participants
13.4  (19.4)
11.Secondary Outcome
Title Maximum Observed Serum Atezolizumab Concentration (Cmax)
Hide Description Maximum observed serum atezolizumab concentration (Cmax) after infusion (Arm A)
Time Frame Day 1 of Cycle 1 (Cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample.
Arm/Group Title Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 273
Mean (Standard Deviation)
Unit of Measure: μg/mL
403  (118)
12.Secondary Outcome
Title Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Hide Description [Not Specified]
Time Frame Prd (0 h), 5-10 minutes (mins) before end of carboplatin infusion (infusion duration=1-2 h), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample.
Arm/Group Title Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cy1D1 Predose Number Analyzed 24 participants
NA [1]   (NA)
Cy1D1 Before End of Infusion Number Analyzed 18 participants
14900  (4260)
Cy1D1 Post Infusion Number Analyzed 23 participants
12800  (4470)
Cy3D1 Predose Number Analyzed 20 participants
220  (83.8)
Cy3D1 Before End of Infusion Number Analyzed 17 participants
17900  (4390)
Cy3D1 Post Infusion Number Analyzed 15 participants
13900  (4080)
[1]
Predose of Cycle 1 Day 1 administration of Carboplatin.
13.Secondary Outcome
Title Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Hide Description [Not Specified]
Time Frame Prd (0 h), 5-10 mins before end of cisplatin infusion (infusion duration=30-60 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample.
Arm/Group Title Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cy1D1 Predose Number Analyzed 9 participants
NA [1]   (NA)
Cy1D1 Before End of Infusion Number Analyzed 6 participants
3630  (589)
Cy1D1 Post Infusion Number Analyzed 7 participants
2400  (360)
Cy3D1 Predose Number Analyzed 8 participants
290  (86.1)
Cy3D1 Before End of Infusion Number Analyzed 7 participants
3020  (968)
Cy3D1 Post Infusion Number Analyzed 7 participants
2740  (543)
[1]
Predose of Cycle 1 Day 1 administration of Cisplatin.
14.Secondary Outcome
Title Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Hide Description [Not Specified]
Time Frame Prd (0 h), 5-10 mins before end of pemetrexed infusion (infusion duration=10 mins), 1 h post-infusion on D1 of Cy1,3 (Cy length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analyses were based on PK observations from all patients who received atezolizumab, carboplatin, cisplatin or pemetrexed treatment and who provided at least one evaluable PK sample.
Arm/Group Title Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cy1D1 Predose Number Analyzed 34 participants
NA [1]   (NA)
Cy1D1 Before End of Infusion Number Analyzed 26 participants
86500  (41600)
Cy1D1 Post Infusion Number Analyzed 33 participants
43600  (15800)
Cy3D1 Predose Number Analyzed 28 participants
1.83  (0.681)
Cy3D1 Before End of Inufsion Number Analyzed 22 participants
79400  (44400)
Cy3D1 Post Infusion Number Analyzed 27 participants
50100  (26100)
[1]
Predose of Cycle 1 Day 1 administration of Pemetrexed.
15.Secondary Outcome
Title Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) of Atezolizumab
Hide Description Baseline prevalence and post-baseline incidence of anti-drug antibodies (ADA) to Atezolizumab in the Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed)
Time Frame Prd (0 h) on D1 of Cy1,2,3,4,8,16 (Cy length=21 days) and thereafter on D1 of every 8th cycle, at treatment discontinuation & then every 30 days (up to 120 days) after last dose of atezolizumab (up to app 25 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ADA evaluable population was defined as patients with a non-missing baseline ADA sample and >=1 non-missing post-baseline ADA sample.
Arm/Group Title Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description:
Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
Overall Number of Participants Analyzed 291
Measure Type: Number
Unit of Measure: Percentage of Participants
Baseline Evaluable Participants Number Analyzed 277 participants
1.8
Post-Baseline Evaluable Participants Number Analyzed 271 participants
35.4
Time Frame From the first study drug to the data cutoff date: 18 July 2019 (up to approximately 39 months).
Adverse Event Reporting Description The safety population was defined as patients who received any amount of study treatment. Patients who received any amount of atezolizumab were analyzed as part the Atezo+PP arm even if atezolizumab was given in error. Patients who were randomized to the study but did not receive any study drug were not included in the safety population.
 
Arm/Group Title Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Hide Arm/Group Description Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w, and as per investigator's choice of either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain AUC =6 mg/mL/min or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period for 4 or 6 cycles (Cycle length=21 days). Participants who do not experience disease progression during the induction phase will begin maintenance therapy. Participants will receive IV infusion of 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period. Participants received intravenous (IV) infusion of 1200 milligrams (mg) of atezolizumab on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 6 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive IV infusion of 1200 mg of atezolizumab and 500 mg/m^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.
All-Cause Mortality
Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Affected / at Risk (%) Affected / at Risk (%)
Total   187/274 (68.25%)      192/291 (65.98%)    
Hide Serious Adverse Events
Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   89/274 (32.48%)      146/291 (50.17%)    
Blood and lymphatic system disorders     
ANAEMIA  1  7/274 (2.55%)  10 10/291 (3.44%)  13
BONE MARROW FAILURE  1  0/274 (0.00%)  0 1/291 (0.34%)  1
FEBRILE BONE MARROW APLASIA  1  1/274 (0.36%)  1 1/291 (0.34%)  1
FEBRILE NEUTROPENIA  1  5/274 (1.82%)  5 12/291 (4.12%)  12
LEUKOPENIA  1  1/274 (0.36%)  1 2/291 (0.69%)  2
NEUTROPENIA  1  3/274 (1.09%)  3 3/291 (1.03%)  3
PANCYTOPENIA  1  4/274 (1.46%)  6 4/291 (1.37%)  4
THROMBOCYTOPENIA  1  4/274 (1.46%)  4 11/291 (3.78%)  15
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION  1  2/274 (0.73%)  3 1/291 (0.34%)  1
ATRIAL FIBRILLATION  1  1/274 (0.36%)  1 1/291 (0.34%)  1
CARDIAC FAILURE  1  0/274 (0.00%)  0 1/291 (0.34%)  1
CARDIAC FAILURE ACUTE  1  1/274 (0.36%)  1 0/291 (0.00%)  0
MYOCARDITIS  1  1/274 (0.36%)  1 1/291 (0.34%)  1
STRESS CARDIOMYOPATHY  1  1/274 (0.36%)  1 0/291 (0.00%)  0
SUPRAVENTRICULAR TACHYCARDIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
TACHYCARDIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
Endocrine disorders     
HYPOTHYROIDISM  1  0/274 (0.00%)  0 1/291 (0.34%)  1
Eye disorders     
CATARACT  1  0/274 (0.00%)  0 2/291 (0.69%)  2
Gastrointestinal disorders     
ABDOMINAL PAIN  1  2/274 (0.73%)  2 4/291 (1.37%)  4
AUTOIMMUNE COLITIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
COLITIS  1  0/274 (0.00%)  0 2/291 (0.69%)  2
CONSTIPATION  1  1/274 (0.36%)  1 1/291 (0.34%)  1
DIARRHOEA  1  3/274 (1.09%)  3 9/291 (3.09%)  9
DIVERTICULUM INTESTINAL HAEMORRHAGIC  1  0/274 (0.00%)  0 1/291 (0.34%)  1
ENTEROCOLITIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
GASTRIC PERFORATION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
GASTROINTESTINAL DISORDER  1  1/274 (0.36%)  1 0/291 (0.00%)  0
INGUINAL HERNIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
INTESTINAL OBSTRUCTION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
NAUSEA  1  2/274 (0.73%)  2 2/291 (0.69%)  2
OESOPHAGITIS  1  0/274 (0.00%)  0 1/291 (0.34%)  3
PANCREATITIS  1  1/274 (0.36%)  1 0/291 (0.00%)  0
PROCTITIS ULCERATIVE  1  0/274 (0.00%)  0 1/291 (0.34%)  1
SMALL INTESTINAL PERFORATION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
STOMATITIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
UPPER GASTROINTESTINAL HAEMORRHAGE  1  0/274 (0.00%)  0 1/291 (0.34%)  1
VOMITING  1  0/274 (0.00%)  0 6/291 (2.06%)  6
General disorders     
ASTHENIA  1  2/274 (0.73%)  2 5/291 (1.72%)  5
CHEST PAIN  1  2/274 (0.73%)  2 0/291 (0.00%)  0
DEATH  1  1/274 (0.36%)  1 2/291 (0.69%)  2
DISEASE SUSCEPTIBILITY  1  0/274 (0.00%)  0 1/291 (0.34%)  1
FATIGUE  1  0/274 (0.00%)  0 2/291 (0.69%)  2
GAIT DISTURBANCE  1  0/274 (0.00%)  0 1/291 (0.34%)  1
GENERAL PHYSICAL HEALTH DETERIORATION  1  1/274 (0.36%)  1 3/291 (1.03%)  4
INFLAMMATION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
MALAISE  1  2/274 (0.73%)  2 1/291 (0.34%)  1
MUCOSAL INFLAMMATION  1  1/274 (0.36%)  1 1/291 (0.34%)  1
NON-CARDIAC CHEST PAIN  1  2/274 (0.73%)  2 0/291 (0.00%)  0
PAIN  1  2/274 (0.73%)  2 0/291 (0.00%)  0
PYREXIA  1  1/274 (0.36%)  2 12/291 (4.12%)  12
Hepatobiliary disorders     
AUTOIMMUNE HEPATITIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
BILE DUCT OBSTRUCTION  1  1/274 (0.36%)  2 0/291 (0.00%)  0
CHOLANGITIS  1  1/274 (0.36%)  1 0/291 (0.00%)  0
CHOLELITHIASIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
DRUG-INDUCED LIVER INJURY  1  0/274 (0.00%)  0 2/291 (0.69%)  2
HEPATIC CONGESTION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
HEPATITIS  1  1/274 (0.36%)  1 1/291 (0.34%)  1
HEPATITIS ACUTE  1  0/274 (0.00%)  0 1/291 (0.34%)  1
HEPATOTOXICITY  1  0/274 (0.00%)  0 2/291 (0.69%)  2
Immune system disorders     
CYTOKINE RELEASE SYNDROME  1  0/274 (0.00%)  0 1/291 (0.34%)  1
HYPERSENSITIVITY  1  0/274 (0.00%)  0 2/291 (0.69%)  2
Infections and infestations     
BACTERAEMIA  1  1/274 (0.36%)  1 0/291 (0.00%)  0
BRONCHITIS  1  0/274 (0.00%)  0 2/291 (0.69%)  2
BRONCHOPULMONARY ASPERGILLOSIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
CAMPYLOBACTER GASTROENTERITIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
CATHETER SITE CELLULITIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
CELLULITIS  1  2/274 (0.73%)  2 3/291 (1.03%)  3
DIVERTICULITIS  1  1/274 (0.36%)  1 1/291 (0.34%)  1
ENCEPHALITIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
ERYSIPELAS  1  1/274 (0.36%)  1 0/291 (0.00%)  0
ESCHERICHIA URINARY TRACT INFECTION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
H3N2 INFLUENZA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
INFECTIOUS PLEURAL EFFUSION  1  1/274 (0.36%)  1 0/291 (0.00%)  0
INFLUENZA  1  1/274 (0.36%)  1 3/291 (1.03%)  3
LOWER RESPIRATORY TRACT INFECTION  1  2/274 (0.73%)  2 0/291 (0.00%)  0
LUNG INFECTION  1  3/274 (1.09%)  3 5/291 (1.72%)  5
MENINGITIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
NEUTROPENIC SEPSIS  1  1/274 (0.36%)  1 1/291 (0.34%)  1
OESOPHAGEAL CANDIDIASIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
PERIPHERAL NERVE INFECTION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
PHARYNGITIS  1  0/274 (0.00%)  0 2/291 (0.69%)  2
PNEUMONIA  1  13/274 (4.74%)  14 13/291 (4.47%)  13
PULMONARY SEPSIS  1  0/274 (0.00%)  0 2/291 (0.69%)  2
PYELONEPHRITIS  1  1/274 (0.36%)  1 0/291 (0.00%)  0
RESPIRATORY TRACT INFECTION  1  2/274 (0.73%)  3 5/291 (1.72%)  8
SEPSIS  1  2/274 (0.73%)  2 2/291 (0.69%)  2
SOFT TISSUE INFECTION  1  1/274 (0.36%)  1 1/291 (0.34%)  1
TRACHEITIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
URINARY TRACT INFECTION  1  2/274 (0.73%)  2 6/291 (2.06%)  6
UROSEPSIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
Injury, poisoning and procedural complications     
FEMUR FRACTURE  1  0/274 (0.00%)  0 1/291 (0.34%)  1
INFUSION RELATED REACTION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
INTENTIONAL OVERDOSE  1  0/274 (0.00%)  0 1/291 (0.34%)  1
LUMBAR VERTEBRAL FRACTURE  1  0/274 (0.00%)  0 1/291 (0.34%)  1
SKIN INJURY  1  1/274 (0.36%)  1 0/291 (0.00%)  0
STAB WOUND  1  0/274 (0.00%)  0 1/291 (0.34%)  1
SUBDURAL HAEMATOMA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
TOXICITY TO VARIOUS AGENTS  1  1/274 (0.36%)  1 0/291 (0.00%)  0
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  1/274 (0.36%)  1 3/291 (1.03%)  3
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/274 (0.36%)  1 1/291 (0.34%)  1
BLOOD CREATININE INCREASED  1  0/274 (0.00%)  0 2/291 (0.69%)  2
CREATININE RENAL CLEARANCE DECREASED  1  1/274 (0.36%)  1 0/291 (0.00%)  0
NEUTROPHIL COUNT DECREASED  1  3/274 (1.09%)  5 0/291 (0.00%)  0
PLATELET COUNT DECREASED  1  3/274 (1.09%)  3 1/291 (0.34%)  1
WEIGHT DECREASED  1  0/274 (0.00%)  0 1/291 (0.34%)  1
WHITE BLOOD CELL COUNT DECREASED  1  1/274 (0.36%)  1 0/291 (0.00%)  0
Metabolism and nutrition disorders     
DECREASED APPETITE  1  2/274 (0.73%)  2 1/291 (0.34%)  1
DEHYDRATION  1  4/274 (1.46%)  4 2/291 (0.69%)  2
DIABETES MELLITUS INADEQUATE CONTROL  1  0/274 (0.00%)  0 1/291 (0.34%)  1
GOUT  1  0/274 (0.00%)  0 1/291 (0.34%)  1
HYPERCALCAEMIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
HYPERGLYCAEMIA  1  0/274 (0.00%)  0 3/291 (1.03%)  4
HYPERKALAEMIA  1  1/274 (0.36%)  1 0/291 (0.00%)  0
HYPOKALAEMIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
HYPOMAGNESAEMIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
HYPONATRAEMIA  1  1/274 (0.36%)  1 2/291 (0.69%)  2
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  2/274 (0.73%)  2 0/291 (0.00%)  0
BONE PAIN  1  2/274 (0.73%)  2 0/291 (0.00%)  0
FRACTURE PAIN  1  0/274 (0.00%)  0 1/291 (0.34%)  1
MUSCULOSKELETAL CHEST PAIN  1  0/274 (0.00%)  0 1/291 (0.34%)  1
MYALGIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
NECK PAIN  1  0/274 (0.00%)  0 1/291 (0.34%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ADENOCARCINOMA GASTRIC  1  1/274 (0.36%)  1 0/291 (0.00%)  0
CANCER PAIN  1  0/274 (0.00%)  0 1/291 (0.34%)  1
HISTIOCYTIC NECROTISING LYMPHADENITIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
METASTASES TO CENTRAL NERVOUS SYSTEM  1  0/274 (0.00%)  0 1/291 (0.34%)  1
PROSTATE CANCER RECURRENT  1  1/274 (0.36%)  1 0/291 (0.00%)  0
TUMOUR EMBOLISM  1  1/274 (0.36%)  1 1/291 (0.34%)  1
Nervous system disorders     
APHASIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
ATAXIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
BRAIN OEDEMA  1  0/274 (0.00%)  0 1/291 (0.34%)  2
CAROTID ARTERY OCCLUSION  1  1/274 (0.36%)  1 0/291 (0.00%)  0
CAROTID ARTERY STENOSIS  1  1/274 (0.36%)  1 0/291 (0.00%)  0
CEREBRAL HAEMORRHAGE  1  0/274 (0.00%)  0 1/291 (0.34%)  1
CEREBRAL INFARCTION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
CEREBROVASCULAR ACCIDENT  1  1/274 (0.36%)  1 4/291 (1.37%)  4
HEADACHE  1  0/274 (0.00%)  0 2/291 (0.69%)  2
LETHARGY  1  1/274 (0.36%)  1 0/291 (0.00%)  0
SEIZURE  1  1/274 (0.36%)  1 1/291 (0.34%)  1
SYNCOPE  1  2/274 (0.73%)  2 0/291 (0.00%)  0
TRANSIENT ISCHAEMIC ATTACK  1  0/274 (0.00%)  0 1/291 (0.34%)  1
Product Issues     
DEVICE MALFUNCTION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
Psychiatric disorders     
ANXIETY  1  1/274 (0.36%)  1 0/291 (0.00%)  0
CATATONIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
COMPLETED SUICIDE  1  0/274 (0.00%)  0 1/291 (0.34%)  1
Renal and urinary disorders     
ACUTE KIDNEY INJURY  1  1/274 (0.36%)  1 3/291 (1.03%)  3
CHRONIC KIDNEY DISEASE  1  1/274 (0.36%)  2 0/291 (0.00%)  0
GLYCOSURIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
NEPHRITIS ALLERGIC  1  0/274 (0.00%)  0 2/291 (0.69%)  2
RENAL FAILURE  1  2/274 (0.73%)  2 1/291 (0.34%)  1
RENAL IMPAIRMENT  1  0/274 (0.00%)  0 1/291 (0.34%)  1
TUBULOINTERSTITIAL NEPHRITIS  1  0/274 (0.00%)  0 2/291 (0.69%)  2
Reproductive system and breast disorders     
BENIGN PROSTATIC HYPERPLASIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
Respiratory, thoracic and mediastinal disorders     
ATELECTASIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
BRONCHIAL HYPERREACTIVITY  1  0/274 (0.00%)  0 1/291 (0.34%)  1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  2/274 (0.73%)  2 2/291 (0.69%)  2
DYSPNOEA  1  3/274 (1.09%)  3 2/291 (0.69%)  4
EPISTAXIS  1  1/274 (0.36%)  1 1/291 (0.34%)  1
HAEMOPTYSIS  1  1/274 (0.36%)  1 1/291 (0.34%)  1
HYPERVENTILATION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
INTERSTITIAL LUNG DISEASE  1  1/274 (0.36%)  1 1/291 (0.34%)  1
ORGANISING PNEUMONIA  1  1/274 (0.36%)  1 0/291 (0.00%)  0
PHARYNGEAL INFLAMMATION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
PLEURAL EFFUSION  1  3/274 (1.09%)  4 1/291 (0.34%)  1
PNEUMONIA ASPIRATION  1  1/274 (0.36%)  1 2/291 (0.69%)  2
PNEUMONITIS  1  4/274 (1.46%)  4 9/291 (3.09%)  9
PNEUMOTHORAX  1  1/274 (0.36%)  1 0/291 (0.00%)  0
PULMONARY EMBOLISM  1  4/274 (1.46%)  4 4/291 (1.37%)  4
PULMONARY HAEMORRHAGE  1  1/274 (0.36%)  1 0/291 (0.00%)  0
RESPIRATORY FAILURE  1  0/274 (0.00%)  0 1/291 (0.34%)  1
Skin and subcutaneous tissue disorders     
DERMATITIS  1  0/274 (0.00%)  0 2/291 (0.69%)  2
RASH  1  0/274 (0.00%)  0 1/291 (0.34%)  1
RASH MACULO-PAPULAR  1  0/274 (0.00%)  0 2/291 (0.69%)  2
Vascular disorders     
AORTIC EMBOLUS  1  1/274 (0.36%)  1 0/291 (0.00%)  0
DEEP VEIN THROMBOSIS  1  1/274 (0.36%)  1 1/291 (0.34%)  1
EMBOLISM  1  0/274 (0.00%)  0 1/291 (0.34%)  1
HYPERTENSION  1  1/274 (0.36%)  1 0/291 (0.00%)  0
HYPOTENSION  1  0/274 (0.00%)  0 1/291 (0.34%)  1
PERIPHERAL ARTERY THROMBOSIS  1  1/274 (0.36%)  1 0/291 (0.00%)  0
PERIPHERAL ISCHAEMIA  1  0/274 (0.00%)  0 1/291 (0.34%)  1
THROMBOPHLEBITIS  1  1/274 (0.36%)  1 0/291 (0.00%)  0
VASCULITIS  1  0/274 (0.00%)  0 1/291 (0.34%)  1
1
Term from vocabulary, MedDRA Version 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm B (Carboplatin or Cisplatin + Pemetrexed) Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   254/274 (92.70%)      275/291 (94.50%)    
Blood and lymphatic system disorders     
ANAEMIA  1  113/274 (41.24%)  140 128/291 (43.99%)  182
NEUTROPENIA  1  38/274 (13.87%)  65 47/291 (16.15%)  94
THROMBOCYTOPENIA  1  23/274 (8.39%)  37 39/291 (13.40%)  60
Endocrine disorders     
HYPOTHYROIDISM  1  2/274 (0.73%)  2 16/291 (5.50%)  17
Eye disorders     
LACRIMATION INCREASED  1  18/274 (6.57%)  21 16/291 (5.50%)  16
Gastrointestinal disorders     
ABDOMINAL PAIN UPPER  1  5/274 (1.82%)  7 15/291 (5.15%)  20
CONSTIPATION  1  79/274 (28.83%)  96 92/291 (31.62%)  104
DIARRHOEA  1  47/274 (17.15%)  56 58/291 (19.93%)  81
DYSPEPSIA  1  9/274 (3.28%)  10 16/291 (5.50%)  18
NAUSEA  1  114/274 (41.61%)  206 109/291 (37.46%)  262
STOMATITIS  1  23/274 (8.39%)  26 35/291 (12.03%)  44
VOMITING  1  49/274 (17.88%)  64 58/291 (19.93%)  80
General disorders     
ASTHENIA  1  54/274 (19.71%)  81 79/291 (27.15%)  116
CHEST PAIN  1  18/274 (6.57%)  18 21/291 (7.22%)  24
FATIGUE  1  68/274 (24.82%)  98 69/291 (23.71%)  110
MALAISE  1  17/274 (6.20%)  23 14/291 (4.81%)  23
MUCOSAL INFLAMMATION  1  19/274 (6.93%)  28 23/291 (7.90%)  24
OEDEMA PERIPHERAL  1  33/274 (12.04%)  38 45/291 (15.46%)  63
PYREXIA  1  37/274 (13.50%)  50 56/291 (19.24%)  84
Infections and infestations     
CONJUNCTIVITIS  1  15/274 (5.47%)  18 17/291 (5.84%)  22
UPPER RESPIRATORY TRACT INFECTION  1  10/274 (3.65%)  13 16/291 (5.50%)  22
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  23/274 (8.39%)  29 52/291 (17.87%)  73
ASPARTATE AMINOTRANSFERASE INCREASED  1  27/274 (9.85%)  34 51/291 (17.53%)  78
BLOOD CREATININE INCREASED  1  20/274 (7.30%)  26 34/291 (11.68%)  42
NEUTROPHIL COUNT DECREASED  1  48/274 (17.52%)  108 45/291 (15.46%)  115
PLATELET COUNT DECREASED  1  38/274 (13.87%)  69 38/291 (13.06%)  63
WEIGHT DECREASED  1  16/274 (5.84%)  17 26/291 (8.93%)  26
WHITE BLOOD CELL COUNT DECREASED  1  29/274 (10.58%)  67 20/291 (6.87%)  55
Metabolism and nutrition disorders     
DECREASED APPETITE  1  64/274 (23.36%)  84 77/291 (26.46%)  100
HYPERGLYCAEMIA  1  17/274 (6.20%)  20 13/291 (4.47%)  15
HYPOKALAEMIA  1  4/274 (1.46%)  4 21/291 (7.22%)  29
HYPOMAGNESAEMIA  1  14/274 (5.11%)  19 19/291 (6.53%)  31
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  17/274 (6.20%)  19 33/291 (11.34%)  38
BACK PAIN  1  25/274 (9.12%)  28 38/291 (13.06%)  45
PAIN IN EXTREMITY  1  13/274 (4.74%)  13 22/291 (7.56%)  22
Nervous system disorders     
DIZZINESS  1  24/274 (8.76%)  27 19/291 (6.53%)  22
DYSGEUSIA  1  19/274 (6.93%)  19 28/291 (9.62%)  33
HEADACHE  1  23/274 (8.39%)  25 35/291 (12.03%)  38
PARAESTHESIA  1  14/274 (5.11%)  16 10/291 (3.44%)  10
Psychiatric disorders     
INSOMNIA  1  18/274 (6.57%)  18 28/291 (9.62%)  35
Respiratory, thoracic and mediastinal disorders     
COUGH  1  30/274 (10.95%)  36 43/291 (14.78%)  54
DYSPNOEA  1  40/274 (14.60%)  42 42/291 (14.43%)  48
EPISTAXIS  1  19/274 (6.93%)  22 13/291 (4.47%)  16
HICCUPS  1  17/274 (6.20%)  24 16/291 (5.50%)  35
RHINORRHOEA  1  14/274 (5.11%)  15 8/291 (2.75%)  10
Skin and subcutaneous tissue disorders     
DRY SKIN  1  7/274 (2.55%)  7 19/291 (6.53%)  22
PRURITUS  1  16/274 (5.84%)  17 27/291 (9.28%)  34
RASH  1  21/274 (7.66%)  23 41/291 (14.09%)  53
Vascular disorders     
HYPERTENSION  1  6/274 (2.19%)  8 17/291 (5.84%)  20
1
Term from vocabulary, MedDRA Version 22.0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02657434    
Other Study ID Numbers: GO29438
2015-003605-42 ( EudraCT Number )
First Submitted: January 14, 2016
First Posted: January 15, 2016
Results First Submitted: July 7, 2020
Results First Posted: October 9, 2020
Last Update Posted: October 29, 2020