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).

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

723

Study ID:

NCT02367781

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 130 Locations for this study

See Locations Near You

Highlands Oncology Group
Springdale Arkansas, 72762, United States
Kaiser Permanente Oakland Medical Center
Oakland California, 94611, United States
Kaiser Permanente Medical Center - Roseville
Roseville California, 95661, United States
Kaiser Permanente - Sacramento Medical Center and Medical Offices
Sacramento California, 95825, United States
Kaiser Permanente - San Francisco Medical Center
San Francisco California, 94118, United States
Kaiser Permanente - San Jose Medical Center
San Jose California, 95119, United States
Kaiser Permanente - San Leandro Medical Center
San Leandro California, 94577, United States
Kaiser Permanente - Santa Clara
Santa Clara California, 95051, United States
Kaiser Permanente - South San Francisco
South San Francisco California, 94080, United States
Kaiser Permanente; Oncology Clinical Trials
Vallejo California, 94589, United States
Kaiser Permanente - Walnut Creek
Walnut Creek California, 94596, United States
Banner MD Anderson Cancer Center
Greeley Colorado, 85234, United States
Eastern Connecticut Hematology and Oncology Associates; (ECHO)
Norwich Connecticut, 06360, United States
University of Miami School of Medicine - Sylvester at Deerfield
Deerfield Beach Florida, Suite, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
Florida Hospital
Orlando Florida, 32803, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
Saint Petersburg Florida, 33705, United States
SCRI Florida Cancer Specialists East
West Palm Beach Florida, 33401, United States
University Cancer & Blood Center, LLC; Research
Athens Georgia, 30607, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Carrollton Georgia, 30117, United States
Suburban Hematology / Oncology Associates
Lawrenceville Georgia, 30046, United States
Southeastern Regional Medical Center, Inc.
Newnan Georgia, 30265, United States
University of Illinois at Chicago
Chicago Illinois, 60612, United States
Joliet Oncology-Hematology; Associates, Ltd.
Joliet Illinois, 60435, United States
Illinois Cancer Care
Peoria Illinois, 61615, United States
Quincy Medical Group
Quincy Illinois, 62301, United States
Southern Illinois University, Simmons Cancer Institute
Springfield Illinois, 62794, United States
Fort Wayne Med Oncology & Hematology Inc
Fort Wayne Indiana, 46845, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Lahey Clinic Med Ctr
Lexington Kentucky, 02421, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20814, United States
Center For Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Southcoast Health System
Fairhaven Massachusetts, 02719, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Hematology and Oncology Associates at Bridgepoint
Tupelo Mississippi, 38801, United States
Southeast Nebraska Cancer Ctr
Lincoln Nebraska, 68510, United States
Va Sierra Nevada Health Care System
Reno Nevada, 89502, United States
Englewood Hospital and Medical Center
Englewood New Jersey, 07631, United States
Saint Barnabas Medical Center
Livingston New Jersey, 07039, United States
Cancer Inst. of New Jersey
New Brunswick New Jersey, 08901, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York New York, 10016, United States
Clinical Research Alliance
Westbury New York, 11590, United States
Presbyterian Hospital
Charlotte North Carolina, 28204, United States
Duke University Medical Center; Department of Medicine
Durham North Carolina, 27710, United States
W.G. Bill Hefner VA Medical Center
Salisbury North Carolina, , United States
The Christ Hospital
Cincinnati Ohio, 45219, United States
Mark H. Zangmeister Center
Columbus Ohio, 43219, United States
Oncology Hematology Care, Inc.
Hamilton Ohio, 45103, United States
Pinnacle Health
Harrisburg Pennsylvania, 17110, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17604, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Greenville Health System; Cancer Center
Greenville South Carolina, 29605, United States
University Oncology Associates
Chattanooga Tennessee, 37403, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
SCRI The Center For Cancer and Blood Disorders
Denton Texas, 76210, United States
University of Texas M.D. Anderson Cancer Center
Houston Texas, 77030, United States
Cancer Care Network of South Texas - SAT & BC
San Antonio Texas, 78217, United States
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
CHU Ambroise Paré
Mons , 7000, Belgium
Werken Glorieux VZW
Ronse , 9600, Belgium
GasthuisZusters Antwerpen
Wilrijk , 2610, Belgium
BC Cancer - Surrey
Surrey British Columbia, V3V 1, Canada
Royal Victoria Regional Health Centre
Barrie Ontario, L4M 6, Canada
William Osler Health Centre
Etobicoke Ontario, M9V 1, Canada
Cite de La Sante de Laval; Hemato-Oncologie
Laval Quebec, H7M 3, Canada
Hôpital Maisonneuve - Rosemont
Montreal Quebec, H1T 2, Canada
Polyclinique Bordeaux Nord Aquitaine
Bordeaux , 33300, France
Institut Hospitalier Franco-Britannique; Cancerologie
Levallois-Perret , 92300, France
Fondation Hopital Saint Joseph;Cardiologie Clinique
Marseille , 13285, France
Clinique Clementville; Hopital De Jour
Montpellier , 34070, France
Centre D'oncologie de Gentilly; Service Oncologie Medicale
Nancy , 54100, France
Clinique Catherine de Sienne
Nantes , 44202, France
Hopital American de Paris (American Hospital of Paris)
Neuilly sur Seine , 92200, France
HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune
Orleans , 45100, France
Hopital Pontchaillou
Rennes , 35033, France
Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
Saint Pierre , 97448, France
Hopital d'Instruction des Armees de Begin
Saint-Mande , 94160, France
CHRU Nancy; Pneumologie
Vandoeuvre-lès-nancy , 54511, France
Charite - Universitätsmedizin Berlin; Klinik fur Infektiologie und Pneumologie
Berlin , 13353, Germany
Klinikum Chemnitz gGmbH
Chemnitz , 09116, Germany
Bezirksklinikum Obermain
Ebensfeld , 96250, Germany
Helios Klinikum Erfurt
Erfurt , 99089, Germany
St. Antonius Hospital
Eschweiler , 52249, Germany
Klinikum Esslingen GmbH; Frauenklinik
Esslingen Am Neckar , 73730, Germany
Malteser Krankenhaus St. Franziskus-Hospital
Flensburg , 24939, Germany
Krankenhaus Nordwest
Frankfurt am Main , 60488, Germany
Asklepios Fachkliniken GmbH
Gauting , 82131, Germany
SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie
Gera , 07548, Germany
Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
Gerlingen , 70839, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg , 69126, Germany
Fachklinik für Lungenerkrankungen
Immenhausen , 34376, Germany
St. Vincentius Kliniken Karlsruhe
Karlsruhe , 76137, Germany
Klinikum Kassel; Hautklinik
Kassel , 34125, Germany
Katholisches Klinikum Marienhof
Koblenz Am Rhein , 56073, Germany
Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I
Lubeck , 23538, Germany
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim , 68167, Germany
Johannes Wesling Klinikum Minden
Minden , 32429, Germany
LMU Klinikum der Universitat Munchen
Munchen , 80337, Germany
Universitätsklinikum Tübingen
Tuebingen , 72076, Germany
Praxis fur Haematologie und Internistische Onkologie
Velbert , 42551, Germany
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
Villingen-Schwenningen , 78052, Germany
Helios Klinik Wuppertal
Wuppertal , 42283, Germany
Soroka University Medical Centre
Beer Sheva , 84101, Israel
Assaf Harofeh Medical Center
Beer Yaakov , 70300, Israel
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem , 91120, Israel
Meir Medical Center; Oncology
Kfar-Saba , 44281, Israel
Galilee Medical Center
Nahariya , 22100, Israel
Rabin Medical Center
Petach Tiqwa , 49100, Israel
Chaim Sheba Medical Center
Ramat Gan , 52656, Israel
Rambam Health Corporation; Oncology Institute
Rambam , 35254, Israel
Kaplan Medical Center
Rehovot , 76100, Israel
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv , 64239, Israel
Ospedale Clinicizzato SS Annunziata
Chieti Abruzzo, 66100, Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
Avellino Campania, 83100, Italy
Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica
Napoli Campania, 80131, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli Campania, 80131, Italy
Ospedale Di Macerata; Oncologia
Macerata Marche, 62100, Italy
Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera
Perugia Umbria, 06129, Italy
Consorcio Hospitalario Provincial de Castellon
Castellon DE LA Plana/castello DE LA Plana Castellon, 12002, Spain
Hospital Son Llatzer
Palma de Mallorca Islas Baleares, 07198, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña LA Coruña, 15006, Spain
Hospital Universitario de Torrejon
Torrejon de Ardoz Madrid, 28850, Spain
Hospital Universitario de Canarias
S. Cristobal De La Laguna Tenerife, 38320, Spain
Hospital Santa Creu i Sant Pau
Barcelona , 08041, Spain
Hospital de San Pedro de Alcantara
Caceres , 10003, Spain
Hospital Universitario Virgen de Las Nieves
Granada , 18012, Spain
Hospital General Universitario de Guadalajara
Guadalajara , 19002, Spain
Complejo Hospitalario de Jaen
Jaen , 23007, Spain
Hospital General Universitario de Valencia
Valencia , 46014, Spain
Hospital NisA 9 de Octubre
Valencia , 46015, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza , 50009, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

723

Study ID:

NCT02367781

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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