Lung Cancer Clinical Trial

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Summary

This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group performance status 0 or 1
Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
Participants with no prior treatment for Stage IV non-squamous NSCLC
Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a 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:

1202

Study ID:

NCT02366143

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 231 Locations for this study

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Ironwood Cancer & Research Centers
Chandler Arizona, 85224, United States
Arizona Oncology Associates
Flagstaff Arizona, 86001, United States
Southern CA Permanente Med Grp
Bellflower California, , United States
Marin Cancer Care Inc
Greenbrae California, 94904, United States
Scripps Health
La Jolla California, 92037, United States
Chao Family Comprehensive Cancer Center UCI
Orange California, 92868, United States
Rocky Mountain Cancer Center
Denver Colorado, 80218, United States
Kaiser Permanente
Lonetree Colorado, 80124, United States
Danbury Hospital
Danbury Connecticut, 06810, United States
Yale Cancer Center
New Haven Connecticut, 06520, United States
Holy Cross Hospital Inc
Fort Lauderdale Florida, 33308, United States
Cancer Specialists of North Florida - Baptist South
Jacksonville Florida, 32258, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie Florida, 34952, United States
Piedmont Cancer Institute, PC
Atlanta Georgia, 30318, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Univ of Chicago
Chicago Illinois, 60637, United States
Ingalls Memorial Hospital
Harvey Illinois, 60426, United States
Oncology Specialists, S.C.
Park Ridge Illinois, 60068, United States
Hematology-Oncology; Associates of the Quad Cities
Bettendorf Iowa, 52722, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
New England Cancer Specialists
Scarborough Maine, 04074, United States
Mercy Medical Center
Baltimore Maryland, 21202, United States
Regional Cancer Care Associates
Bethesda Maryland, 20817, United States
Maryland Oncology Hematology, P.A.
Columbia Maryland, 21044, United States
St. Joseph Mercy Health System
Ann Arbor Michigan, 48106, United States
St. Luke's Regional Cancer Center
Duluth Minnesota, 55805, United States
Park Nicolett - Frauenshuh Cancer Center
Saint Louis Park Minnesota, 55426, United States
St. Luke's Cancer Institute
Kansas City Missouri, 64111, United States
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
Billings Clinic
Billings Montana, 59102, United States
Montana Cancer Specialists
Missoula Montana, 59802, United States
Comprehensive Cancer Centers of Nevada
Henderson Nevada, 89014, United States
Summit Medical Group
Berkeley Heights New Jersey, 07922, United States
Valley Hospital; Oncology Research
Paramus New Jersey, 07652, United States
Regional Cancer Care Associates LLC
Sewell New Jersey, 08080, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Maimonides Medical Center
Brooklyn New York, 11219, United States
First Health of the Carolinas
Pinehurst North Carolina, 28374, United States
University of Cincinnati
Cincinnati Ohio, 45203, United States
Mercy St Anne Hospital
Toledo Ohio, 43623, United States
Bend Memorial Clinic
Bend Oregon, 97701, United States
St. Charles Medical Center Bend; Cancer Care Of The Cascades
Bend Oregon, 97701, United States
Willamette Valley Cancer Insitute and Research Center
Springfield Oregon, 97477, United States
St. Luke's Cancer Care Associates
Bethlehem Pennsylvania, 18015, United States
Allegheny Cancer Center
Pittsburgh Pennsylvania, 15212, United States
Univ of Pittsburgh Medical Ctr
Pittsburgh Pennsylvania, 15232, United States
West Clinic
Germantown Tennessee, 38138, United States
Tennessee Cancer Specialists
Knoxville Tennessee, 37920, United States
Houston Methodist Cancer Center
Houston Texas, 77030, United States
Longview Cancer Center
Longview Texas, 75601, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Virginia Cancer Institute
Richmond Virginia, 23226, United States
Blue Ridge Cancer Care
Roanoke Virginia, 24014, United States
MultiCare Regional Cancer Center - Auburn
Auburn Washington, 98002, United States
Providence Regional Cancer Partnership
Everett Washington, 98201, United States
Virginia Mason Medical Center
Seattle Washington, 98101, United States
Medical Oncology Associates
Spokane Washington, 99208, United States
West Virginia University; Mary Babb Randolph Can Ctr
Morgantown West Virginia, 26506, United States
Centro Medico Austral
Buenos Aires , 1019, Argentina
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
Hospital Provincial del Centenario
Rosario , 2000, Argentina
Fundacion Koriza
Santa Rosa , 6300, Argentina
Centro de Investigacion; Clinica - Clinica Viedma S.A.
Viedma , R8500, Argentina
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
Concord Repatriation General Hospital
Concord New South Wales, 2139, Australia
Nepean Cancer Care Centre
Sydney New South Wales, 2747, Australia
Prince Charles Hospital; Department of Medical Oncology
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
Adelaide Cancer Centre
Kurralta Park South Australia, 5037, Australia
Royal Hobart Hospital
Hobart Tasmania, 7000, Australia
Launceston General Hospital
Launceston Tasmania, 7250, Australia
Frankston Hospital
Frankston Victoria, 3199, Australia
Austin Health
Heidelberg Victoria, 3084, Australia
Cabrini Hospital Malvern
Malvern Victoria, 3144, Australia
The Alfred Hospital
Prahan Victoria, 3181, Australia
Sunshine Hospital
St Albans Victoria, 3021, Australia
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia
Paracelsus Medizinische Privatuniversität
Salzburg , 5020, Austria
Klinikum Wels-Grieskirchen
Wels , 4600, Austria
CHU de Liège
Liège , 4000, Belgium
Clinique Ste-Elisabeth
Namur , 5000, Belgium
CETUS Hospital Dia Oncologia
Uberaba MG, 38082, 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 Mae de Deus
Porto Alegre RS, 90470, Brazil
Hospital de Cancer de Barretos
Barretos SP, 14784, Brazil
Instituto Ribeirãopretano de Combate Ao Câncer; Centro Especializado De Oncologia
Ribeirão Preto SP, 14015, Brazil
Hospital de Base de Sao Jose do Rio Preto
Sao Jose do Rio Preto SP, 15090, Brazil
Hospital A. C. Camargo; Oncologia
Sao Paulo SP, 01509, Brazil
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv , 4000, Bulgaria
MHAT Serdika, EOOD
Sofia , 1303, Bulgaria
Lakeridge Health Center
Oshawa Ontario, L1J 2, Canada
Clinica Santa Maria
Santiago , 0, Chile
Health & Care SPA
Santiago , 75000, Chile
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco , 48104, Chile
Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux , 33076, France
CHU de Grenoble
Grenoble , 38043, France
Centre Jean Bernard Clinique Victor Hugo
Le Mans , 72015, France
Hôpital Saint Joseph
Marseille , 13008, France
Hopital Nord AP-HM
Marseille , 13015, France
Hôpital Européen Georges Pompidou
Paris , 75908, France
CHU de Bordeaux
Pessac , 33600, France
Service de Pneumologie Centre Hospitalier Régional La Réunion Site Felix Guyon
Saint Denis Cedex , 97405, France
CH de Saint Quentin
Saint Quentin , 2100, France
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
Toulon , 83000, France
Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie
Toulon , 83000, France
Hôpital Larrey;Université Paul Sabatier
Toulouse , 31059, France
Zentralklinikum Augsburg
Augsburg , 86156, Germany
Helios Klinikum Emil von Behring GmbH
Berlin , 14165, 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
LungenClinic Großhansdorf GmbH
Großhansdorf , 22927, Germany
Krankenhaus Martha-Maria; Halle-Dolau gGmbH
Halle , 06120, Germany
Asklepios Klinik Harburg
Hamburg , 21075, Germany
Lungenklinik Hemer
Hemer , 58675, Germany
Universität Des Saarlandes; Klinik für Innere Medizin V
Homburg , 66421, Germany
Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz
Koln , 51109, Germany
Klinik Loewenstein gGmbH; Onk & Pal
Loewenstein , 74245, Germany
Klinikum Bogenhausen
München , 81925, Germany
Krankenhaus Barmherzige Bruder Regensburg
Regensburg , 93049, Germany
Klinikum der Universität Regensburg
Regensburg , 93053, Germany
Stiftung Mathias-Spital Rheine
Rheine , 48431, Germany
AORN A Cardarelli
Napoli Campania, 80131, Italy
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Roma Lazio, 00128, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma Lazio, 00152, Italy
Università Cattolica Del S Cuore
Roma Lazio, 00168, Italy
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova Liguria, 16132, Italy
ASL 3 Genovese; DSM
Genova Liguria, 16147, Italy
A.O.U. Maggiore della Carità
Novara Piemonte, 28100, Italy
Azienda Unita Sanitaria Locale N1 Sassari; Unita Operativa Di Oncologia Medica
Sassari Sardegna, 07100, Italy
Policlinico Vittorio Emanuele
Catania Sicilia, 95123, Italy
Ospedale Versilia
Lido Di Camaiore Toscana, 55043, Italy
Ospedale Civile - Livorno
Livorno Toscana, 57124, Italy
National Hospital Organization Shikoku Cancer Center
Ehime , 791-0, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka , 810-8, Japan
NHO Kyushu Cancer Center
Fukuoka , 811-1, Japan
Kurume University Hospital
Fukuoka , 830-0, Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa , 236-0, Japan
Kitasato University Hospital
Kanagawa , 252-0, Japan
Kyoto University Hospital
Kyoto , 606-8, Japan
Miyagi Cancer Center
Miyagi , 981-1, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Osaka City University Hospital
Osaka , 545-8, Japan
National Hospital Organization Osaka Toneyama Medical Center
Osaka , 560-8, Japan
Toranomon Hospital
Tokyo , 105-8, Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo , 162-0, Japan
Kyorin University Hospital
Tokyo , 181-8, Japan
Wakayama Medical University Hospital
Wakayama , 641-8, 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
Cancerologia de Queretaro
Queretaro , 76090, Mexico
Centro Hemato Oncologico Privado; Oncologia
Toluca , 50080, Mexico
Jeroen Bosch Ziekenhuis
'S Hertogenbosch , 5223 , Netherlands
Amsterdam UMC Location VUMC
Amsterdam , 1081 , Netherlands
Amphia Ziekenhuis; Afdeling Longziekten
Breda , 4818 , Netherlands
Ziekenhuis Gelderse Vallei
EDE , 6716 , Netherlands
Tergooiziekenhuizen
Hilversum , 1201 , Netherlands
Spaarne Gasthuis; Spaarne Ziekenhuis
Hoofddorp , 2134 , Netherlands
Maastricht University Medical Center
Maastricht , 6229 , Netherlands
St. Antonius Ziekenhuis; R&D Long
Nieuwegein , 3435 , Netherlands
Erasmus MC; Afdeling Longziekten
Rotterdam , 3015 , Netherlands
Maasstad ziekenhuis
Rotterdam , 3079 , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht , 3584 , Netherlands
Gelre Ziekenhuizen, Zutphen
Zutphen , 7207 , Netherlands
Centro Medico Monte Carmelo
Arequipa , 04001, Peru
Centro Especializado de Enfermedades Neoplásicas
Arequipa , , Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima , Lima , Peru
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra , 3000-, Portugal
Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE
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
Evromedservis LCC
Pushkin , 19660, Russian Federation
City Clinical Oncology Dispensary
Saint-Petersburg , 19702, Russian Federation
National Cancer Centre; Medical Oncology
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
Santander Cantabria, 39008, Spain
Hospital Universitario Son Espases
Palma De Mallorca Islas Baleares, 07014, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria LAS Palmas, 35016, Spain
Complejo Hospitalario U. de Ourense
Ourense Orense, 32005, Spain
Hospital Lluis Alcanyis De Xativa
Xativa Valencia, 46800, 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 Universitario Reina Sofia
Cordoba , 14004, 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
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario Fundación Jimenez Díaz
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario HM Sanchinarro-CIOCC
Madrid , 28050, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Kantonsspital Baselland
Bruderholz , 4101, Switzerland
Luzerner Kantonsspital Sursee
Luzern , 6000, Switzerland
Kantonsspital St. Gallen; Onkologie/Hämatologie
St. Gallen , 9007, Switzerland
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
National Cheng Kung Univ Hosp
Tainan , 00704, Taiwan
National Taiwan Uni Hospital
Taipei City , 10041, Taiwan
Cheng Hsin General Hospital
Taipei , 112, Taiwan
Tri-Service General Hospital
Taipei , 11490, Taiwan
Chang Gung Medical Foundation Linkou Branch
Taoyuan City , 333, Taiwan
Taichung Veterans General Hospital
Xitun Dist. , 40705, Taiwan
ME Bukovinian Clinical Oncology Center
Chernivtsi Chernihiv Governorate, 58013, Ukraine
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
MNPE Transcarpathian Antitumor Center of the Transcarpathian Regional Council; Chemotherapy Dept
Uzhhorod Kherson Governorate, 88014, Ukraine
Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2
Ivano-Frankivsk KIEV Governorate, 76018, Ukraine
Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
Vinnytsia KIEV Governorate, 21029, 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
Kyiv City Clinical Oncological Center
Kyiv , 03115, 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:

1202

Study ID:

NCT02366143

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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