Clinical trial · Interventional
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)
A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody | Drug | — | UNRESOLVED |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A (Atezolizumab+Paclitaxel+Carboplatin)
- 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.
- interventionNames
- Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
- Drug: Carboplatin
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (9)
- DERIVEDZhou 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. PMID 40379995
- DERIVEDMang A, Zou W, Rolny V, Reck M, Cigoianu D, Schulze K, Holdenrieder S, Socinski MA, Shames DS, Wehnl B, Patil NS. Combined use of CYFRA 21-1 and CA 125 predicts survival of patients with metastatic NSCLC and stable disease in IMpower150. Tumour Biol. 2024;46(s1):S177-S190. doi: 10.3233/TUB-230001. PMID 37545290
- DERIVEDSocinski 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
- DERIVEDTon TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471. PMID 35511917
- DERIVEDNogami 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.