A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
CompletedPhase 3Results postedLast updated 9 August 2021
What this trial tests
Phase 3 trial testing Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody in Carcinoma, Non-Squamous Non-Small Cell Lung in 723 participants. Completed in 18 January 2021.
18 and older, any sex, with Carcinoma, Non-Squamous Non-Small Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the ITT-WT PopulationPrimary· Up to approximately 35 months after first patient enrolled
PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first in the ITT-WT population.
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
7.0
6.3 – 7.3
Arm B (Nab-Paclitaxel+Carboplatin)
5.5
4.4 – 5.9
Overall Survival (OS) in the ITT-WT PopulationPrimary· Up to approximately 35 months after first patient enrolled
OS is defined as the time between the date of randomization and date of death from any cause in the ITT-WT population.
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
18.6
15.8 – 21.2
Arm B (Nab-Paclitaxel+Carboplatin)
13.9
12.0 – 18.7
PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT PopulationSecondary· Up to approximately 35 months after first subject enrolled
PFS is defined as the time between the date of randomization and the date of first documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first. The ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT partic
ITT Population
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
7.0
6.3 – 7.3
Arm B (Nab-Paclitaxel+Carboplatin)
5.6
4.5 – 5.9
TC1/2/3 or IC1/2/3 ITT Population
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
7.5
7.0 – 9.1
Arm B (Nab-Paclitaxel+Carboplatin)
5.7
4.5 – 6.6
TC1/2/3 or IC1/2/3-WT ITT Population
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
7.5
7.0 – 9.0
Arm B (Nab-Paclitaxel+Carboplatin)
5.9
4.5 – 6.6
OS as Determined by the Investigator Using Recist v1.1 in the ITT PopulationSecondary· Up to approximately 41 months after first subject enrolled
OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
17.0
14.9 – 19.7
Arm B (Nab-Paclitaxel+Carboplatin)
13.5
11.9 – 17.7
OS as Determined by the Investigator Using RECIST v1.1 in the PD-L1 Expression Population and PD-L1 Expression WT PopulationSecondary· Up to approximately 35 months after first patient enrolled
OS is defined as the time between the date of randomization and date of death from any cause in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expressio
TC1/2/3 or IC1/2/3 ITT Population
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
21.2
17.3 – 28.2
Arm B (Nab-Paclitaxel+Carboplatin)
16.9
12.5 – 22.0
TC1/2/3 or IC1/2/3 WT ITT Population
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
21.2
18.1 – 28.2
Arm B (Nab-Paclitaxel+Carboplatin)
16.9
12.5 – 22.0
Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT PopulationSecondary· Up to approximately 41 months after first subject enrolled
ORR (confirmation not required) is defined as the proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by the investigator in the ITT-WT population.
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
60.2
Arm B (Nab-Paclitaxel+Carboplatin)
41.0
Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT PopulationSecondary· Up to approximately 35 months after first subject enrolled
ORR (confirmation not required) is defined as proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by investigator in ITT population, PD-L1 Expression population, and PD-L1 Expression WT population. ITT population was defined as all randomized participants, regardless of receipt of the assigned treatment. PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 po
ITT Population
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
59.1
Arm B (Nab-Paclitaxel+Carboplatin)
42.2
TC1/2/3 or IC1/2/3 ITT WT Population
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
65.6
Arm B (Nab-Paclitaxel+Carboplatin)
46.2
TC1/2/3 or IC1/2/3 ITT Population
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
64.6
Arm B (Nab-Paclitaxel+Carboplatin)
45.0
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 in ITT-WT Population, ITT Population, and PD-L1 Expression Population and PD-L1 Expression WT PopulationSecondary· Up to approximately 35 months after first subject enrolled
DOR,defined for participants with objective response (OR) as time from 1st documented OR to documented disease progression as determined by investigator using RECIST v1.1,or death from any cause,whichever occurs 1st.ITT defined as all randomized participants,regardless of receipt of assigned treatment.ITT-WT defined as ITT population excluding participants with activating EGFR mutation or ALK translocation.PD-L1 expression population is defined as one of following:PD-L1 IHC TC1/2/3 or IC1/2/3 population,defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor
ITT Population
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
6.2
5.6 – 7.9
Arm B (Nab-Paclitaxel+Carboplatin)
5.4
4.1 – 5.8
ITT-WT Population
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
6.7
5.6 – 8.0
Arm B (Nab-Paclitaxel+Carboplatin)
5.4
3.9 – 5.8
TC1/2/3 or IC1/2/3 ITT Population
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
7.2
5.7 – 9.0
Arm B (Nab-Paclitaxel+Carboplatin)
5.0
3.2 – 6.1
TC1/2/3 or IC1/2/3 ITT WT Population
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
7.2
5.7 – 9.0
Arm B (Nab-Paclitaxel+Carboplatin)
5.0
3.2 – 6.1
Event Free Rate (%) at Year 1 and 2 in ITT-WT Population and ITT PopulationSecondary· Up to 41 months after first patient enrolled, years 1 and 2 reported
The OS rate at the 1- and 2-year landmark time points after randomization.
Event Free Rate (%) at Year 1 ITT WT
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
62.02
57.53 – 66.51
Arm B (Nab-Paclitaxel+Carboplatin)
54.56
48.04 – 61.08
Event Free Rate (%) at Year 2 ITT WT
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
40.43
35.64 – 45.22
Arm B (Nab-Paclitaxel+Carboplatin)
32.36
25.80 – 38.92
Event Free Rate (%) at Year 1 ITT
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
61.65
57.29 – 66.02
Arm B (Nab-Paclitaxel+Carboplatin)
54.47
48.09 – 60.84
Event Free Rate (%) at Year 2 ITT
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
39.73
35.10 – 44.37
Arm B (Nab-Paclitaxel+Carboplatin)
32.21
25.79 – 38.63
Event Free Rate (%) at Year 1 and 2 in PD-L1 Expression Population and PD-L1 Expression WT PopulationSecondary· Up to 35 months after first patient enrolled, years 1 and 2 reported
The OS rate at the 1- and 2-year landmark time points after randomization in the PD-L1 Expression Population and PD-L1 Expression WT Population. The PD-L1 expression population is defined as one of the following: PD-L1 IHC TC1/2/3 or IC1/2/3 population, defined as ITT participants with PD-L1 IHC TC1/2/3 or IC1/2/3 expression in baseline tumor tissue; PD-L1 IHC TC2/3 or IC2/3 population, defined as ITT participants with PD-L1 IHC TC2/3 or IC2/3 expression in baseline tumor tissue; PD-L1 IHC TC3 or IC3 population, defined as ITT participants with PD-L1 IHC TC3 or IC3 expression in baseline tumor
Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
68.56
62.46 – 74.66
Arm B (Nab-Paclitaxel+Carboplatin)
61.86
52.55 – 71.17
Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
44.63
35.99 – 53.27
Arm B (Nab-Paclitaxel+Carboplatin)
35.98
23.25 – 48.72
Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT WT
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
68.84
62.56 – 75.13
Arm B (Nab-Paclitaxel+Carboplatin)
62.51
53.07 – 71.94
Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT WT
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
44.02
34.86 – 53.18
Arm B (Nab-Paclitaxel+Carboplatin)
35.33
22.06 – 48.60
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT PopulationSecondary· Up to approximately 35 months after first subject enrolled
Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales.
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
2.2
1.8 – 3.1
Arm B (Nab-Paclitaxel+Carboplatin)
1.9
1.5 – 2.4
Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) ScaleSecondary· Up to approximately 35 months after first subject enrolled
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 questi
Chest Pain, Week 1
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
0.19
± 0.86
Arm B (Nab-Paclitaxel+Carboplatin)
0.14
± 0.90
Chest Pain, Week 2
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
-0.02
± 0.89
Arm B (Nab-Paclitaxel+Carboplatin)
0.03
± 0.91
Chest Pain, Week 3
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
-0.05
± 0.95
Arm B (Nab-Paclitaxel+Carboplatin)
0.01
± 0.92
Chest Pain, Week 4
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
-0.11
± 0.95
Arm B (Nab-Paclitaxel+Carboplatin)
0.01
± 1.02
Chest Pain, Week 5
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
-0.12
± 0.99
Arm B (Nab-Paclitaxel+Carboplatin)
0.00
± 1.03
Chest Pain, Week 6
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
-0.24
± 1.07
Arm B (Nab-Paclitaxel+Carboplatin)
0.03
± 1.03
Chest Pain, Week 7
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
-0.23
± 1.11
Arm B (Nab-Paclitaxel+Carboplatin)
0.03
± 1.08
Chest Pain, Week 8
Group
Value
95% CI
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
-0.21
± 0.99
Arm B (Nab-Paclitaxel+Carboplatin)
-0.14
± 1.00
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first study drug to the data cutoff date: 18 January 2021 (approximately 69 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
Serious: 252/473 (53%)
Deaths: 338/473
Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin)
Serious: 63/131 (48%)
Deaths: 108/131
Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy)
This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 9 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02367781.