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Brief Title: 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)
Official Title: 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
Study ID: NCT02367781
Brief 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Highlands Oncology Group, Springdale, Arkansas, United States
Kaiser Permanente Oakland Medical Center, Oakland, California, United States
Kaiser Permanente Medical Center - Roseville, Roseville, California, United States
Kaiser Permanente - Sacramento Medical Center and Medical Offices, Sacramento, California, United States
Kaiser Permanente - San Francisco Medical Center, San Francisco, California, United States
Kaiser Permanente - San Jose Medical Center, San Jose, California, United States
Kaiser Permanente - San Leandro Medical Center, San Leandro, California, United States
Kaiser Permanente - Santa Clara, Santa Clara, California, United States
Kaiser Permanente - South San Francisco, South San Francisco, California, United States
Kaiser Permanente; Oncology Clinical Trials, Vallejo, California, United States
Kaiser Permanente - Walnut Creek, Walnut Creek, California, United States
Banner MD Anderson Cancer Center, Greeley, Colorado, United States
Eastern Connecticut Hematology and Oncology Associates; (ECHO), Norwich, Connecticut, United States
University of Miami School of Medicine - Sylvester at Deerfield, Deerfield Beach, Florida, United States
SCRI Florida Cancer Specialists South, Fort Myers, Florida, United States
Florida Hospital, Orlando, Florida, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building), Saint Petersburg, Florida, United States
SCRI Florida Cancer Specialists East, West Palm Beach, Florida, United States
University Cancer & Blood Center, LLC; Research, Athens, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Carrollton, Georgia, United States
Suburban Hematology / Oncology Associates, Lawrenceville, Georgia, United States
Southeastern Regional Medical Center, Inc., Newnan, Georgia, United States
University of Illinois at Chicago, Chicago, Illinois, United States
Joliet Oncology-Hematology; Associates, Ltd., Joliet, Illinois, United States
Illinois Cancer Care, Peoria, Illinois, United States
Quincy Medical Group, Quincy, Illinois, United States
Southern Illinois University, Simmons Cancer Institute, Springfield, Illinois, United States
Fort Wayne Med Oncology & Hematology Inc, Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Lahey Clinic Med Ctr, Lexington, Kentucky, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Center For Cancer and Blood Disorders, Bethesda, Maryland, United States
Southcoast Health System, Fairhaven, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Hematology and Oncology Associates at Bridgepoint, Tupelo, Mississippi, United States
Southeast Nebraska Cancer Ctr, Lincoln, Nebraska, United States
Va Sierra Nevada Health Care System, Reno, Nevada, United States
Englewood Hospital and Medical Center, Englewood, New Jersey, United States
Saint Barnabas Medical Center, Livingston, New Jersey, United States
Cancer Inst. of New Jersey, New Brunswick, New Jersey, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone., New York, New York, United States
Clinical Research Alliance, Westbury, New York, United States
Presbyterian Hospital, Charlotte, North Carolina, United States
Duke University Medical Center; Department of Medicine, Durham, North Carolina, United States
W.G. Bill Hefner VA Medical Center, Salisbury, North Carolina, United States
The Christ Hospital, Cincinnati, Ohio, United States
Mark H. Zangmeister Center, Columbus, Ohio, United States
Oncology Hematology Care, Inc., Hamilton, Ohio, United States
Pinnacle Health, Harrisburg, Pennsylvania, United States
Lancaster General Hospital, Lancaster, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Greenville Health System; Cancer Center, Greenville, South Carolina, United States
University Oncology Associates, Chattanooga, Tennessee, United States
SCRI Tennessee Oncology Chattanooga, Chattanooga, Tennessee, United States
SCRI The Center For Cancer and Blood Disorders, Denton, Texas, United States
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Cancer Care Network of South Texas - SAT & BC, San Antonio, Texas, United States
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
CHU Ambroise Paré, Mons, , Belgium
Werken Glorieux VZW, Ronse, , Belgium
GasthuisZusters Antwerpen, Wilrijk, , Belgium
BC Cancer - Surrey, Surrey, British Columbia, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
William Osler Health Centre, Etobicoke, Ontario, Canada
Cite de La Sante de Laval; Hemato-Oncologie, Laval, Quebec, Canada
Hôpital Maisonneuve - Rosemont, Montreal, Quebec, Canada
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
Institut Hospitalier Franco-Britannique; Cancerologie, Levallois-Perret, , France
Fondation Hopital Saint Joseph;Cardiologie Clinique, Marseille, , France
Clinique Clementville; Hopital De Jour, Montpellier, , France
Centre D'oncologie de Gentilly; Service Oncologie Medicale, Nancy, , France
Clinique Catherine de Sienne, Nantes, , France
Hopital American de Paris (American Hospital of Paris), Neuilly sur Seine, , France
HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune, Orleans, , France
Hopital Pontchaillou, Rennes, , France
Centre Hospitalier Regional Sud Reunion; Service de Pneumologie, Saint Pierre, , France
Hopital d'Instruction des Armees de Begin, Saint-Mande, , France
CHRU Nancy; Pneumologie, Vandoeuvre-lès-nancy, , France
Charite - Universitätsmedizin Berlin; Klinik fur Infektiologie und Pneumologie, Berlin, , Germany
Klinikum Chemnitz gGmbH, Chemnitz, , Germany
Bezirksklinikum Obermain, Ebensfeld, , Germany
Helios Klinikum Erfurt, Erfurt, , Germany
St. Antonius Hospital, Eschweiler, , Germany
Klinikum Esslingen GmbH; Frauenklinik, Esslingen Am Neckar, , Germany
Malteser Krankenhaus St. Franziskus-Hospital, Flensburg, , Germany
Krankenhaus Nordwest, Frankfurt am Main, , Germany
Asklepios Fachkliniken GmbH, Gauting, , Germany
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie, Gera, , Germany
Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie, Gerlingen, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Thoraxklinik Heidelberg gGmbH, Heidelberg, , Germany
Fachklinik für Lungenerkrankungen, Immenhausen, , Germany
St. Vincentius Kliniken Karlsruhe, Karlsruhe, , Germany
Klinikum Kassel; Hautklinik, Kassel, , Germany
Katholisches Klinikum Marienhof, Koblenz Am Rhein, , Germany
Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I, Lubeck, , Germany
Klinikum Mannheim GmbH Universitätsklinikum, Mannheim, , Germany
Johannes Wesling Klinikum Minden, Minden, , Germany
LMU Klinikum der Universitat Munchen, Munchen, , Germany
Universitätsklinikum Tübingen, Tuebingen, , Germany
Praxis fur Haematologie und Internistische Onkologie, Velbert, , Germany
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie, Villingen-Schwenningen, , Germany
Helios Klinik Wuppertal, Wuppertal, , Germany
Soroka University Medical Centre, Beer Sheva, , Israel
Assaf Harofeh Medical Center, Beer Yaakov, , Israel
Hadassah Ein Karem Hospital; Oncology Dept, Jerusalem, , Israel
Meir Medical Center; Oncology, Kfar-Saba, , Israel
Galilee Medical Center, Nahariya, , Israel
Rabin Medical Center, Petach Tiqwa, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Rambam Health Corporation; Oncology Institute, Rambam, , Israel
Kaplan Medical Center, Rehovot, , Israel
Tel Aviv Sourasky Medical Ctr; Oncology, Tel Aviv, , Israel
Ospedale Clinicizzato SS Annunziata, Chieti, Abruzzo, Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati, Avellino, Campania, Italy
Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica, Napoli, Campania, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale, Napoli, Campania, Italy
Ospedale Di Macerata; Oncologia, Macerata, Marche, Italy
Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera, Perugia, Umbria, Italy
Consorcio Hospitalario Provincial de Castellon, Castellon DE LA Plana/castello DE LA Plana, Castellon, Spain
Hospital Son Llatzer, Palma de Mallorca, Islas Baleares, Spain
Complejo Hospitalario Universitario A Coruña, A Coruña, LA Coruña, Spain
Hospital Universitario de Torrejon, Torrejon de Ardoz, Madrid, Spain
Hospital Universitario de Canarias, S. Cristobal De La Laguna, Tenerife, Spain
Hospital Santa Creu i Sant Pau, Barcelona, , Spain
Hospital de San Pedro de Alcantara, Caceres, , Spain
Hospital Universitario Virgen de Las Nieves, Granada, , Spain
Hospital General Universitario de Guadalajara, Guadalajara, , Spain
Complejo Hospitalario de Jaen, Jaen, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
Hospital NisA 9 de Octubre, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR