Lung Cancer Clinical Trial

A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]

Summary

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
Measurable disease as defined by RECIST v1.1
Adequate hematologic and end organ function

Exclusion Criteria:

Active or untreated central nervous system (CNS) metastasis
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
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 (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Positive test for Human Immunodeficiency Virus (HIV)
Active hepatitis B or hepatitis C
Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
Severe infection within 4 weeks prior to randomization
Significant history of cardiovascular disease

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1021

Study ID:

NCT02367794

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 233 Locations for this study

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Ironwood Cancer & Research Centers
Chandler Arizona, 85224, United States
Highlands Oncology Group
Springdale Arkansas, 72762, United States
Southern CA Permanente Med Grp
Bellflower California, , United States
Kaiser Permanente Oakland Medical Center
Oakland California, 94611, United States
Kaiser Permanente - Sacramento Medical Center and Medical Offices
Sacramento California, 95825, 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; Oncology Clinical Trials
Vallejo California, 94589, United States
Kaiser Permanente - Walnut Creek
Walnut Creek California, 94596, United States
Rocky Mountain Cancer Center
Denver Colorado, 80218, United States
Danbury Hospital
Danbury Connecticut, 06810, United States
Holy Cross Hospital Inc
Fort Lauderdale Florida, 33308, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
Florida Cancer Specialists
Palm Beach Gardens Florida, 33410, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie Florida, 34952, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
Saint Petersburg Florida, 33705, 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
Central Georgia Cancer Care PC
Macon Georgia, 31201, United States
Southeastern Regional Medical Center, Inc.
Newnan Georgia, 30265, United States
University of Chicago
Chicago Illinois, 60637, United States
Joliet Oncology-Hematology; Associates, Ltd.
Joliet Illinois, 60435, United States
Quincy Medical Group
Quincy Illinois, 62301, United States
Fort Wayne Med Oncology & Hematology Inc
Fort Wayne Indiana, 46845, United States
Hematology-Oncology; Associates of the Quad Cities
Bettendorf Iowa, 52722, United States
Siouxland Hematology/Oncology
Sioux City Iowa, 51101, United States
Lahey Clinic Med Ctr
Lexington Kentucky, 02421, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
New England Cancer Specialists
Scarborough Maine, 04074, United States
Southcoast Health System; Southcoast Centers For Cancer Care
Fairhaven Massachusetts, 02719, United States
St. Joseph Mercy Health System
Ann Arbor Michigan, 48106, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
St. Luke's Regional Cancer Center
Duluth Minnesota, 55805, United States
Hematology and Oncology Associates at Bridgepoint
Tupelo Mississippi, 38801, United States
Billings Clinic
Billings Montana, 59102, United States
Valley Hospital; Oncology Research
Paramus New Jersey, 07652, United States
Regional Cancer Care Associates LLC
Sewell New Jersey, 08080, United States
Clinical Research Alliance
Westbury New York, 11590, United States
W.G. Bill Hefner VA Medical Center
Salisbury North Carolina, , United States
University of Cincinnati
Cincinnati Ohio, 45203, United States
Mark H. Zangmeister Center
Columbus Ohio, 43219, United States
Oncology Hematology Care, Inc.
Hamilton Ohio, 45103, United States
Oregon Health & Science Uni
Portland Oregon, 97239, United States
St. Luke's Cancer Care Associates
Bethlehem Pennsylvania, 18015, United States
Maryland Oncology Hematology (Lanham) - USOR
Gettysburg Pennsylvania, 17325, United States
Allegheny Cancer Center
Pittsburgh Pennsylvania, 15212, United States
Univ of Pittsburgh Medical Ctr
Pittsburgh Pennsylvania, 15232, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
Tennessee Cancer Specialists
Knoxville Tennessee, 37920, United States
SCRI The Center For Cancer and Blood Disorders
Denton Texas, 76210, United States
Longview Cancer Center
Longview Texas, 75601, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Blue Ridge Cancer Care
Roanoke Virginia, 24014, United States
Providence Regional Cancer Partnership
Everett Washington, 98201, United States
Medical Oncology Associates
Spokane Washington, 99208, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires , C1125, Argentina
Sanatorio Allende
Cordoba , X5000, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja , F5300, Argentina
Clínica Pergamino
Pergamino , B2700, Argentina
Fundacion Koriza
Santa Rosa , L6304, Argentina
Centro de Investigacion; Clinica - Clinica Viedma S.A.
Viedma , R8500, Argentina
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah New South Wales, 2298, Australia
Prince Charles Hospital
Chermside Queensland, 4032, Australia
Townsville Hospital
Townsville Queensland, 4810, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Austin Health
Heidelberg Victoria, 3084, Australia
Cabrini Hospital Malvern
Malvern Victoria, 3144, Australia
Sunshine Hospital
St Albans Victoria, 3021, Australia
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia
Paracelsus Medizinische Privatuniversität
Salzburg , 5020, Austria
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
CHU Sart-Tilman
Liège , 4000, Belgium
Clinique Ste-Elisabeth
Namur , 5000, Belgium
Werken Glorieux VZW
Ronse , 9600, Belgium
GasthuisZusters Antwerpen
Wilrijk , 2610, Belgium
Cenantron - Centro Avancado de Tratamento Oncologico
Belo Horizonte MG, 30130, Brazil
Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica
Londrina PR, 86 01, Brazil
Liga Norte Riograndense Contra O Câncer
Natal RN, 59040, Brazil
IPCEM; Instituto de Pesquisa de Estudos Multicêntricos
Caxias do Sul RS, 95070, Brazil
Hospital Bruno Born
Lajeado RS, 95900, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre RS, 90035, Brazil
Hospital Mae de Deus
Porto Alegre RS, 90470, Brazil
*X*Fundação Pio XII Hospital de Câncer de Barretos
Barretos SP, 14784, Brazil
Hospital de Base de Sao Jose do Rio Preto
Sao Jose do Rio Preto SP, 15090, Brazil
Hospital Do Cancer A C Camargo
Sao Paulo SP, 01525, Brazil
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv , 4000, Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia , 1303, Bulgaria
Royal Victoria Regional Health Centre
Barrie Ontario, L4M 6, Canada
William Osler Health Centre
Etobicoke Ontario, M9V 1, Canada
Lakeridge Health Center
Oshawa Ontario, L1J 2, Canada
Cite de La Sante de Laval; Hemato-Oncologie
Laval Quebec, H7M 3, Canada
Hôpital du Sacré-Coeur de Montreal
Montreal Quebec, H4J 1, Canada
St. Jerome Medical Research
St. Jerome Quebec, J7Z 5, Canada
Health & Care SPA
Santiago , 75000, Chile
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco , 48104, Chile
CHU de Grenoble
Grenoble , 38043, France
Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd
Le Mans , 72000, France
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Lyon , 69008, France
Clinique Clémentville
Montpellier , 34070, France
Hopital de La Source
Orleans , 45067, France
Centre Hospitalier Lyon Sud
Pierre Benite , 69495, France
Hopital de Pontchaillou; Service de Pneumologie
Rennes , 35033, France
Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
Saint Pierre , 97448, France
CH de Saint Quentin
Saint Quentin , 2100, France
Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques
Toulon Cedex 9 , 83800, France
Charite - Universitätsmedizin Berlin
Berlin , 12203, Germany
Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie
Bielefeld , 33611, Germany
Augusta Kranken-Anstalt gGmbH
Bochum , 44791, Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden , 01307, Germany
St. Elisabethen Krankenhaus
Frankfurt am Main , 60487, Germany
Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
Gerlingen , 70839, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf , 22927, Germany
Krankenhaus Martha-Maria; Halle-Dolau gGmbH
Halle , 06120, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg , 20246, Germany
Asklepios Klinik Harburg
Hamburg , 21075, Germany
Lungenklinik Hemer
Hemer , 58675, Germany
Universität Des Saarlandes; Klinik für Innere Medizin V
Homburg , 66421, Germany
Fachklinik für Lungenerkrankungen
Immenhausen , 34376, Germany
Kliniken der Stadt Koln gGmbH
Koln , 51109, Germany
Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
Minden , 32429, Germany
Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie
München , 81925, Germany
Krankenhaus Barmherzige Bruder Regensburg
Regensburg , 93049, Germany
Klinikum der Universität Regensburg
Regensburg , 93053, Germany
Stiftung Mathias-Spital Rheine
Rheine , 48431, Germany
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
Villingen-Schwenningen , 78052, Germany
Soroka Medical Center
Beer Sheva , 84101, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem , 91120, Israel
Meir Medical Center; Oncology
Kfar-Saba , 44281, Israel
Rabin Medical Center
Petach Tiqwa , 49414, Israel
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan , 52621, Israel
Rambam Health Corporation; Oncology Institute
Rambam , 35254, Israel
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv , 64239, Israel
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
Avellino Campania, 83100, Italy
AORN A Cardarelli
Napoli Campania, 80131, Italy
Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata
Napoli Campania, 80131, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli Campania, 80131, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma Lazio, 00152, Italy
ASL 3 Genovese; DSM
Genova Liguria, 16147, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia Lombardia, 27100, Italy
IRCCS Giovanni Paolo II Istituto Oncologico
Bari Puglia, 70124, Italy
Policlinico Vittorio Emanuele
Catania Sicilia, 95123, Italy
Ospedale Civile - Livorno
Livorno Toscana, 57124, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa Toscana, 56100, Italy
Ospedale Silvestrini
Perugia Umbria, 06122, Italy
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi , 464-8, Japan
Nagoya University Hospital; Respiratory Medicine
Aichi , 466-8, Japan
National Cancer Center Hospital East; Thoracic Oncology
Chiba , 277-8, Japan
National Hospital Organization Shikoku Cancer Center; Internal Medicine
Ehime , 791-0, Japan
National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine
Fukuoka , 810-8, Japan
Kyushu University Hospital; Respiratory
Fukuoka , 812-8, Japan
Kobe City Medical Center General Hospital; Respiratory Medicine
Hyogo , 650-0, Japan
National Hospital Organization Himeji Medical Center
Hyogo , 670-8, Japan
Hyogo Cancer Center; Thoracic Oncology
Hyogo , 673-8, Japan
Ibaraki Prefectural Central Hospital; Division of respiratory
Ibaraki , 309-1, Japan
Kanagawa Cancer Center;Thoracic Oncology
Kanagawa , 241-8, Japan
Kyoto University Hospital, Respiratory Medicine
Kyoto , 606-8, Japan
Sendai Kousei Hospital; Pulmonary Medicine
Miyagi , 980-0, Japan
Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease
Niigata , 951-8, Japan
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama , 700-8, Japan
Osaka International Cancer Institute; Thoracic Oncology
Osaka , 541-8, Japan
Osaka City Uni Hospital; Respiratory Medicine
Osaka , 545-8, Japan
Kansai Medical university Hospital; Thoracic Oncology
Osaka , 573-1, Japan
Osaka Habikino Medical Center
Osaka , 583-8, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai-shi , 591-8, Japan
Saitama Cancer Center; Thoracic Oncology
Satima , 362-0, Japan
Shizuoka Cancer Center; Thoracic Oncology
Shizuoka , 411-8, Japan
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo , 104-0, Japan
Tokyo Medical University Hospital; Dept of Surgery
Tokyo , 160-0, Japan
Riga East Clinical University Hospital Latvian Oncology Centre
Riga , LV-10, Latvia
Pauls Stradins Clinical University Hospital
RÄ«ga , LV-10, Latvia
National Cancer Institute
Vilnius , 08660, Lithuania
Centro Universitario Contra El Cancer
Monterrey , 64020, Mexico
Cancerología
Queretaro , 76090, Mexico
VU Medisch Centrum; VU University Medical Center
Amsterdam , 1007 , Netherlands
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam , 1066 , Netherlands
Ziekenhuis Gelderse Vallei
EDE , 6716 , Netherlands
Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose
Eindhoven , 5623 , Netherlands
St. Antonius Ziekenhuis; R&D Long
Nieuwegein , 3435 , Netherlands
Centro Medico Monte Carmelo
Arequipa , 04001, Peru
Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
Lima , Lima , Peru
Instituto Regional de Enfermedades Neoplásicas Del Norte
Trujillo , 12345, Peru
IPO de Lisboa; Servico de Pneumologia
Lisboa , 1099-, Portugal
Hospital Pulido Valente; Servico de Pneumologia
Lisboa , 1796-, Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto , 4099-, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
Porto , 4200-, Portugal
Hospital de Sao Joao; Servico de Pneumologia
Porto , 4200, Portugal
Moscow City Oncology Hospital #62
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Russian Oncology Research Center n.a. N.N. Blokhin
Moscow , 11547, Russian Federation
Clinical Oncology Dispensary
Omsk , 64401, Russian Federation
City Clinical Oncology Dispensary
Saint-Petersburg , 19702, Russian Federation
Volgograd Regional Clinical Oncology Dispensary
Volgograd , 40013, Russian Federation
National University Hospital
Singapore , 11907, Singapore
National Cancer Centre
Singapore , 16961, Singapore
Univerzitna nemocnica Bratislava
Bratislava , 813 6, Slovakia
Narodny onkologicky ustav
Bratislava , 833 1, Slovakia
POKO Poprad s.r.o.
Poprad , 058 0, Slovakia
Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell Barcelona, 8208, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander Cantabria, 39008, Spain
Hospital Universitario Son Espases
Palma De Mallorca Islas Baleares, 07014, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña LA Coruña, 15006, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria LAS Palmas, 35016, Spain
Hospital Nuestra Senora de Valme
Seville Sevilla, 41014, Spain
Hospital Universitario de Canarias
S. Cristobal De La Laguna Tenerife, 38320, Spain
Hospital del Mar
Barcelona , 08003, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona , 08041, Spain
Hospital Universitario Reina Sofia
Cordoba , 14008, Spain
Hospital Lucus Augusti; Servicio de Oncologia
Lugo , 27003, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Universitario La Paz
Madrid , 28014, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Fundación Jimenez Díaz
Madrid , 28040, Spain
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid , 28050, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Hospital General Universitario de Valencia
Valencia , 46014, Spain
Hospital Universitario Miguel Servet
Zaragoza , 50009, Spain
Changhua Christian Hospital; Hematology-Oncology
Changhua , 500, Taiwan
Kaohsiung Medical University Hospital; Department of Urology
Kaohsiung City , 807, Taiwan
Chi Mei Medical Center Liou Ying Campus
Liuying Township , 736, Taiwan
Chang Gung Memorial Hospital Chiayi
Putzu , 613, Taiwan
China Medical University Hospital
Taichung , 40447, Taiwan
National Taiwan Uni Hospital
Taipei City , 10041, Taiwan
Mackay Memorial Hospital
Taipei , 104, Taiwan
Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy
Dnipropetrovsk Katerynoslav Governorate, 49102, Ukraine
Uzhgorod Central City Clinical Hospital
Uzhhorod Katerynoslav Governorate, 88000, Ukraine
MNPE Zaporizhzhia Regional Antitumor Center ZRC
Zaporizhzhia Katerynoslav Governorate, 69040, Ukraine
Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs
Kharkiv Kharkiv Governorate, 61070, Ukraine
Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
Vinnytsia KIEV Governorate, 21029, Ukraine
MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy
Lviv Volhynian Governorate, 79031, Ukraine
Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1
Chernivtsi , 58013, Ukraine
SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine
Kharkiv , 61024, Ukraine
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department
Kryvyi Rih , 50048, Ukraine
Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department
Poltava , 36011, Ukraine
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
Sumy , 40005, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

1021

Study ID:

NCT02367794

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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