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)
- Cancer
- Lung Cancer
- Non-Small Cell Lung Cancer (NSCLC)
Completed
- A Coruña
- Antwerpen
- Athens
- Avellino
- Barcelona
- Barrie
- Be'er Sheva
- Be'er Ya'akov
- Berlin
- Bethesda
- Bordeaux
- Bruxelles
- Castelló de la Plana
- Charlotte
- Chattanooga
- Chemnitz
- Chicago
- Chieti
- Cincinnati
- Columbus
- Cáceres
- Denton
- Durham
- Ebensfeld
- Englewood
- Erfurt
- Eschweiler
- Esslingen am Neckar
- Fairhaven
- Flensburg
- Fort Myers
- Fort Wayne
- Frankfurt am Main
- Gera
- Gerlingen
- Gilbert
- Granada
- Greenville
- Guadalajara
- Hannover
- Harrisburg
- Heidelberg
- Houston
- Immenhausen
- Iowa City
- Jaén
- Jerusalem
- Joliet
- Karlsruhe
- Kassel
- Kefar Sava
- Koblenz
- Lancaster
- Laval
- Lawrenceville
- Levallois-Perret
- Lexington
- Lincoln
- Livingston
- Lübeck
- Macerata
- Mannheim
- Marietta
- Marseille
- Miami
- Minden
- Mons
- Montpellier
- Montréal
- München
- Nahariya
- Nancy
- Nantes
- Napoli
- Neuilly-sur-Seine
- New Brunswick
- New Hyde Park
- New York
- Norwich
- Oakland
- Orlando
- Orléans
- Palma
- Peoria
- Perugia
- Petah Tikva
- Providence
- Quincy
- Ramat Gan
- Rehovot
- Renaix
- Rennes
- Reno
- riverdale
- Rochester
- Roseville
- Sacramento
- saint-louis
- Saint-Mandé
- Salisbury
- San Antonio
- San Cristóbal de La Laguna
- San Francisco
- San Jose
- San Leandro
- Santa Clara
- South San Francisco
- Springdale
- Springfield
- St. Petersburg
- Surrey
- Tel Aviv-Yafo
- Toronto
- Torrejón de Ardoz
- Tupelo
- Tübingen
- Vallejo
- València
- Vandœuvre-lès-Nancy
- Velbert
- Villingen-Schwenningen
- Walnut Creek
- West Palm Beach
- Wuppertal
- Zaragoza
NCT02367781 2014-003206-32 GO29537
Trial Summary
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).
A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Eligibility 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
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
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