Lung Cancer Clinical Trial
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)
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).
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
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There are 130 Locations for this study
Springdale Arkansas, 72762, United States
Oakland California, 94611, United States
Roseville California, 95661, United States
Sacramento California, 95825, United States
San Francisco California, 94118, United States
San Jose California, 95119, United States
San Leandro California, 94577, United States
Santa Clara California, 95051, United States
South San Francisco California, 94080, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Greeley Colorado, 85234, United States
Norwich Connecticut, 06360, United States
Deerfield Beach Florida, Suite, United States
Fort Myers Florida, 33916, United States
Orlando Florida, 32803, United States
Saint Petersburg Florida, 33705, United States
West Palm Beach Florida, 33401, United States
Athens Georgia, 30607, United States
Carrollton Georgia, 30117, United States
Lawrenceville Georgia, 30046, United States
Newnan Georgia, 30265, United States
Chicago Illinois, 60612, United States
Joliet Illinois, 60435, United States
Peoria Illinois, 61615, United States
Quincy Illinois, 62301, United States
Springfield Illinois, 62794, United States
Fort Wayne Indiana, 46845, United States
Iowa City Iowa, 52242, United States
Lexington Kentucky, 02421, United States
Bethesda Maryland, 20814, United States
Bethesda Maryland, 20817, United States
Fairhaven Massachusetts, 02719, United States
Rochester Minnesota, 55905, United States
Tupelo Mississippi, 38801, United States
Lincoln Nebraska, 68510, United States
Reno Nevada, 89502, United States
Englewood New Jersey, 07631, United States
Livingston New Jersey, 07039, United States
New Brunswick New Jersey, 08901, United States
New York New York, 10016, United States
Westbury New York, 11590, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Salisbury North Carolina, , United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43219, United States
Hamilton Ohio, 45103, United States
Harrisburg Pennsylvania, 17110, United States
Lancaster Pennsylvania, 17604, United States
Providence Rhode Island, 02903, United States
Greenville South Carolina, 29605, United States
Chattanooga Tennessee, 37403, United States
Chattanooga Tennessee, 37404, United States
Denton Texas, 76210, United States
Houston Texas, 77030, United States
San Antonio Texas, 78217, United States
Bruxelles , 1200, Belgium
Mons , 7000, Belgium
Ronse , 9600, Belgium
Wilrijk , 2610, Belgium
Surrey British Columbia, V3V 1, Canada
Barrie Ontario, L4M 6, Canada
Etobicoke Ontario, M9V 1, Canada
Laval Quebec, H7M 3, Canada
Montreal Quebec, H1T 2, Canada
Bordeaux , 33300, France
Levallois-Perret , 92300, France
Marseille , 13285, France
Montpellier , 34070, France
Nancy , 54100, France
Nantes , 44202, France
Neuilly sur Seine , 92200, France
Orleans , 45100, France
Rennes , 35033, France
Saint Pierre , 97448, France
Saint-Mande , 94160, France
Vandoeuvre-lès-nancy , 54511, France
Berlin , 13353, Germany
Chemnitz , 09116, Germany
Ebensfeld , 96250, Germany
Erfurt , 99089, Germany
Eschweiler , 52249, Germany
Esslingen Am Neckar , 73730, Germany
Flensburg , 24939, Germany
Frankfurt am Main , 60488, Germany
Gauting , 82131, Germany
Gera , 07548, Germany
Gerlingen , 70839, Germany
Hannover , 30625, Germany
Heidelberg , 69126, Germany
Immenhausen , 34376, Germany
Karlsruhe , 76137, Germany
Kassel , 34125, Germany
Koblenz Am Rhein , 56073, Germany
Lubeck , 23538, Germany
Mannheim , 68167, Germany
Minden , 32429, Germany
Munchen , 80337, Germany
Tuebingen , 72076, Germany
Velbert , 42551, Germany
Villingen-Schwenningen , 78052, Germany
Wuppertal , 42283, Germany
Beer Sheva , 84101, Israel
Beer Yaakov , 70300, Israel
Jerusalem , 91120, Israel
Kfar-Saba , 44281, Israel
Nahariya , 22100, Israel
Petach Tiqwa , 49100, Israel
Ramat Gan , 52656, Israel
Rambam , 35254, Israel
Rehovot , 76100, Israel
Tel Aviv , 64239, Israel
Chieti Abruzzo, 66100, Italy
Avellino Campania, 83100, Italy
Napoli Campania, 80131, Italy
Napoli Campania, 80131, Italy
Macerata Marche, 62100, Italy
Perugia Umbria, 06129, Italy
Castellon DE LA Plana/castello DE LA Plana Castellon, 12002, Spain
Palma de Mallorca Islas Baleares, 07198, Spain
A Coruña LA Coruña, 15006, Spain
Torrejon de Ardoz Madrid, 28850, Spain
S. Cristobal De La Laguna Tenerife, 38320, Spain
Barcelona , 08041, Spain
Caceres , 10003, Spain
Granada , 18012, Spain
Guadalajara , 19002, Spain
Jaen , 23007, Spain
Valencia , 46014, Spain
Valencia , 46015, Spain
Zaragoza , 50009, Spain
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