TriangleNCT02366143 · CITED IN SOURCE DOCUMENTS
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2021-09-23
This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population
Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population
Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population
PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population
PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population
PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
PFS, as Determined by the Investigator in Arm B Versus Arm C by PD-L1 Subgroup
OS in Arm B Versus Arm C by PD-L1 Subgroup
OS in Arm A Versus Arm C by PD-L1 Subgroup
OS in Arm B Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
OS in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
Duration of Response (DOR), as Determined By Investigator in Arm B Versus Arm C
Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator in the Teff-High-WT Population and ITT-WT Population
OS Rates at Years 1 and 2 in Arm B Versus Arm C
OS Rates at Years 1 and 2 in Arm A Versus Arm C
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale
Percentage of Participants With Adverse Events
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Arm A and Arm B
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B
Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C
Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
Cmax of Bevacizumab in Arm B and Arm C
Cmin of Bevacizumab in Arm B and Arm C
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Eastern Cooperative Oncology Group performance status 0 or 1 * Histologically or cytologically confirmed, Stage IV non-squamous NSCLC * Participants with no prior treatment for Stage IV non-squamous NSCLC * Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening * Measurable disease as defined by RECIST v1.1 * Adequate hematologic and end organ function Exclusion Criteria: Cancer-Specific Exclusions: * Active or untreated central nervous system metastases * Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome General Medical Exclusions: * Pregnant or lactating women * History of autoimmune disease * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted * Positive test for human immunodeficiency virus * Active hepatitis B or hepatitis C * Severe infection within 4 weeks prior to randomization * Significant cardiovascular disease * Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures Exclusion Criteria Related to Medications: * Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
- intervention Names
- Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
- Drug: Carboplatin
- Drug: Paclitaxel
- label
- Arm A (Atezolizumab+Paclitaxel+Carboplatin)
- type
- EXPERIMENTAL
- description
- Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
- intervention Names
- Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
- Drug: Bevacizumab
- Drug: Carboplatin
- Drug: Paclitaxel
- label
- Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
- type
- EXPERIMENTAL
- description
- Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
- intervention Names
- Drug: Bevacizumab
- Drug: Carboplatin
- Drug: Paclitaxel
- label
- Arm C (Bevacizumab+Paclitaxel+Carboplatin)
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Arm A (Atezolizumab+Paclitaxel+Carboplatin)
- Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
- description
- Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.
- name
- Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
- other Names
- MPDL3280A
- RO5541267
- Tecentriq
- type
- DRUG
- arm Group Labels
- Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
- Arm C (Bevacizumab+Paclitaxel+Carboplatin)
- description
- Bevacizumab was administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, or death.
- name
- Bevacizumab
- type
- DRUG
- arm Group Labels
- Arm A (Atezolizumab+Paclitaxel+Carboplatin)
- Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
- Arm C (Bevacizumab+Paclitaxel+Carboplatin)
- description
- Carboplatin was administered at area under the concentration-time curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
- name
- Carboplatin
- type
- DRUG
- arm Group Labels
- Arm A (Atezolizumab+Paclitaxel+Carboplatin)
- Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
- Arm C (Bevacizumab+Paclitaxel+Carboplatin)
- description
- Paclitaxel was administered as IV infusion at a dose of 200 milligrams per square meter (mg/m\^2) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
- name
- Paclitaxel
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1202
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.
- measure
- Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population
- time Frame
- Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)
- description
- Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population
- measure
- Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population
- time Frame
- Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)
- description
- Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population
- measure
- Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population
- time Frame
- Baseline until death (up approximately 53 months)
- secondary Outcomes
- description
- PFS, as determined by the independent review facility (IRF) Using RECIST v1.1 in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.
- measure
- PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population
- time Frame
- Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
- description
- PFS, as determined by the investigator according to RECIST v1.1, in Arm B versus C in the Teff high population and ITT population.
- measure
- PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population
- time Frame
- Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
- description
- PFS, as determined by the investigator according to RECIST v1.1, in Arm A versus B in the Teff high-WT population and ITT-WT population.
- measure
- PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
- time Frame
- Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
- description
- PFS as Determined by the Investigator according to RECIST v1.1, in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)
- measure
- PFS, as Determined by the Investigator in Arm B Versus Arm C by PD-L1 Subgroup
- time Frame
- Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
- description
- OS in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)
- measure
- OS in Arm B Versus Arm C by PD-L1 Subgroup
- time Frame
- Baseline until death (up to approximately 34 months)
- description
- OS in Arm A Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)
- measure
- OS in Arm A Versus Arm C by PD-L1 Subgroup
- time Frame
- Baseline until death (up approximately 53 months)
- measure
- OS in Arm B Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
- time Frame
- Baseline until death (up to approximately 34 months)
- measure
- OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
- time Frame
- Baseline until death (up approximately 53 months)
- measure
- OS in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
- time Frame
- Baseline until death (up approximately 53 months)
- description
- DOR, as determined by investigator according to RECIST v1.1 in Arm B versus Arm C in the Teff high-WT population and the ITT-WT population.
- measure
- Duration of Response (DOR), as Determined By Investigator in Arm B Versus Arm C
- time Frame
- Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
- description
- 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 Teff-High-WT population and ITT-WT population.
- measure
- Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator in the Teff-High-WT Population and ITT-WT Population
- time Frame
- Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
- description
- OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.
- measure
- OS Rates at Years 1 and 2 in Arm B Versus Arm C
- time Frame
- Baseline to 2 years or death, whichever occurs first.
Full study description
- brief Summary
- This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).
Source references
- references
- citation
- Zhou C, Dong X, Chen G, Wang Z, Wu X, Yao Y, Zhang Y, Cheng Y, Pan H, Zhang X, Cui J, Wang L, Chen X, Li X, Wang Z, Wang Q, He J, Wang M, Yan I, Qian L, Xu M, Huang X, Sun C, Cai J, Wu Q, Ballinger M, Kaul M, Srivastava MK. Atezolizumab plus bevacizumab and chemotherapy in metastatic nonsquamous NSCLC: the randomized double-blind phase 3 IMpower151 trial. Nat Med. 2025 Jul;31(7):2375-2384. doi: 10.1038/s41591-025-03658-y. Epub 2025 May 16.
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- 40379995
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- pmid
- 37545290
- type
- DERIVED
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- Socinski MA, Jotte RM, Cappuzzo F, Nishio M, Mok TSK, Reck M, Finley GG, Kaul MD, Yu W, Paranthaman N, Bara I, West HJ. Association of Immune-Related Adverse Events With Efficacy of Atezolizumab in Patients With Non-Small Cell Lung Cancer: Pooled Analyses of the Phase 3 IMpower130, IMpower132, and IMpower150 Randomized Clinical Trials. JAMA Oncol. 2023 Apr 1;9(4):527-535. doi: 10.1001/jamaoncol.2022.7711.
- pmid
- 36795388
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- pmid
- 35511917
- type
- DERIVED
- citation
- Nogami N, Barlesi F, Socinski MA, Reck M, Thomas CA, Cappuzzo F, Mok TSK, Finley G, Aerts JG, Orlandi F, Moro-Sibilot D, Jotte RM, Stroyakovskiy D, Villaruz LC, Rodriguez-Abreu D, Wan-Teck Lim D, Merritt D, Coleman S, Lee A, Shankar G, Yu W, Bara I, Nishio M. IMpower150 Final Exploratory Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in Key NSCLC Patient Subgroups With EGFR Mutations or Metastases in the Liver or Brain. J Thorac Oncol. 2022 Feb;17(2):309-323. doi: 10.1016/j.jtho.2021.09.014. Epub 2021 Oct 7.
- pmid
- 34626838
- type
- DERIVED
- citation
- Socinski MA, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kong S, Lee A, Coleman S, Zou W, McCleland M, Shankar G, Reck M. IMpower150 Final Overall Survival Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Nonsquamous NSCLC. J Thorac Oncol. 2021 Nov;16(11):1909-1924. doi: 10.1016/j.jtho.2021.07.009. Epub 2021 Jul 24.
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- 34311108
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- Reck M, Wehler T, Orlandi F, Nogami N, Barone C, Moro-Sibilot D, Shtivelband M, Gonzalez Larriba JL, Rothenstein J, Fruh M, Yu W, Deng Y, Coleman S, Shankar G, Patel H, Kelsch C, Lee A, Piault E, Socinski MA. Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer. J Clin Oncol. 2020 Aug 1;38(22):2530-2542. doi: 10.1200/JCO.19.03158. Epub 2020 May 27.
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- 32459597
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- Reck M, Mok TSK, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Lee A, Coleman S, Deng Y, Kowanetz M, Shankar G, Lin W, Socinski MA; IMpower150 Study Group. Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial. Lancet Respir Med. 2019 May;7(5):387-401. doi: 10.1016/S2213-2600(19)30084-0. Epub 2019 Mar 25.
- pmid
- 30922878
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- Socinski MA, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kelsch C, Lee A, Coleman S, Deng Y, Shen Y, Kowanetz M, Lopez-Chavez A, Sandler A, Reck M; IMpower150 Study Group. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med. 2018 Jun 14;378(24):2288-2301. doi: 10.1056/NEJMoa1716948. Epub 2018 Jun 4.
- pmid
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- type
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