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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)

NCT02367781

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Carcinoma, Non-Squamous Non-Small Cell Lung

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

Countries: United States, Belgium, Canada, France, Germany, Israel, Italy, Spain

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Eastern Cooperative Oncology Group performance status of 0 or 1
* Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
* Participants with no prior treatment for Stage IV non-squamous NSCLC
* Previously obtained archival tumor tissue or tissue obtained from fresh 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 (132)

Springdale, Arkansas, United States
Oakland, California, United States
Roseville, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Jose, California, United States
San Leandro, California, United States
Santa Clara, California, United States
South San Francisco, California, United States
Vallejo, California, United States
Walnut Creek, California, United States
Greeley, Colorado, United States
Norwich, Connecticut, United States
Deerfield Beach, Florida, United States
Fort Myers, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Athens, Georgia, United States
Carrollton, Georgia, United States
Lawrenceville, Georgia, United States
Newnan, Georgia, United States
Chicago, Illinois, United States
Joliet, Illinois, United States
Peoria, Illinois, United States
Quincy, Illinois, United States
Springfield, Illinois, United States
Fort Wayne, Indiana, United States
Iowa City, Iowa, United States
Lexington, Kentucky, United States
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