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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)

NCT02366143

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Bevacizumab, Carboplatin, Paclitaxel

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (240)

Chandler, Arizona, United States
Flagstaff, Arizona, United States
Bellflower, California, United States
Greenbrae, California, United States
La Jolla, California, United States
Orange, California, United States
Denver, Colorado, United States
Lonetree, Colorado, United States
Danbury, Connecticut, United States
New Haven, Connecticut, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Miami Beach, Florida, United States
Port Saint Lucie, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Harvey, Illinois, United States
Park Ridge, Illinois, United States
Bettendorf, Iowa, United States
Louisville, Kentucky, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Columbia, Maryland, United States
Ann Arbor, Michigan, United States
Duluth, Minnesota, United States
Saint Louis Park, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
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