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) (IMpower150)

August 26, 2021 updated by: Hoffmann-La Roche

A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1202

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1125ABD
        • Fundacion CENIT para la investigacion en Neurociencias
      • Buenos Aires, Argentina, 1019
        • Centro Medico Austral
      • Cordoba, Argentina, X5000JHQ
        • Sanatorio Allende
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral (CORI)
      • Rosario, Argentina, 2000
        • Hospital Provincial del Centenario
      • Santa Rosa, Argentina, 6300
        • Fundacion Koriza
      • Viedma, Argentina, R8500ACE
        • Centro de Investigacion; Clinica - Clinica Viedma S.A.
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Sydney, New South Wales, Australia, 2747
        • Nepean Cancer Care Centre
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Prince Charles Hospital; Department of Medical Oncology
      • Townsville, Queensland, Australia, 4810
        • Townsville Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Kurralta Park, South Australia, Australia, 5037
        • Adelaide Cancer Centre
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
      • Launceston, Tasmania, Australia, 7250
        • Launceston General Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital Malvern
      • Prahan, Victoria, Australia, 3181
        • The Alfred Hospital
      • St Albans, Victoria, Australia, 3021
        • Sunshine Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Austria
      • Salzburg, Austria, 5020
        • Paracelsus Medizinische Privatuniversitat
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen
  • Belgium
      • Liège, Belgium, 4000
        • CHU de Liege
      • Namur, Belgium, 5000
        • Clinique Ste-Elisabeth
  • Brazil
    • MG
      • Uberaba, MG, Brazil, 38082-049
        • CETUS Hospital Dia Oncologia
    • PR
      • Londrina, PR, Brazil, 86 015 520
        • Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica
    • RN
      • Natal, RN, Brazil, 59040150
        • Liga Norte Riograndense Contra O Câncer
    • RS
      • Caxias do Sul, RS, Brazil, 95070-560
        • IPCEM; Instituto de Pesquisa de Estudos Multicêntricos
      • Porto Alegre, RS, Brazil, 90470-340
        • Hospital Mãe de Deus
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Hospital de Cancer de Barretos
      • Ribeirão Preto, SP, Brazil, 14015-130
        • Instituto Ribeirãopretano de Combate Ao Câncer; Centro Especializado De Oncologia
      • Sao Jose do Rio Preto, SP, Brazil, 15090-000
        • Hospital de Base de São José do Rio Preto
      • Sao Paulo, SP, Brazil, 01509-010
        • Hospital A. C. Camargo; Oncologia
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
      • Sofia, Bulgaria, 1303
        • MHAT Serdika, EOOD
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1J 2J2
        • Lakeridge Health Center
  • Chile
      • Santiago, Chile
        • Clínica Santa María
      • Santiago, Chile, 7500006
        • Health & Care SPA
      • Temuco, Chile, 4810469
        • Sociedad de Investigaciones Medicas Ltda (SIM)
  • France
      • Bordeaux, France, 33076
        • Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
      • Grenoble, France, 38043
        • Chu de Grenoble
      • Le Mans, France, 72015
        • Centre Jean Bernard Clinique Victor Hugo
      • Marseille, France, 13015
        • Hopital Nord AP-HM
      • Marseille, France, 13008
        • Hôpital Saint Joseph
      • Paris, France, 75908
        • Hopital Europeen Georges Pompidou
      • Pessac, France, 33600
        • CHU de Bordeaux
      • Saint Denis Cedex, France, 97405
        • Service de Pneumologie Centre Hospitalier Régional La Réunion Site Felix Guyon
      • Saint Quentin, France, 2100
        • CH de Saint Quentin
      • Toulon, France, 83000
        • Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie
      • Toulon, France, 83000
        • Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
      • Toulouse, France, 31059
        • Hôpital Larrey;Université Paul Sabatier
  • Germany
      • Augsburg, Germany, 86156
        • Zentralklinikum Augsburg
      • Berlin, Germany, 14165
        • Helios Klinikum Emil von Behring GmbH
      • Bielefeld, Germany, 33611
        • Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie
      • Bochum, Germany, 44791
        • Augusta Kranken-Anstalt gGmbH
      • Dresden, Germany, 01307
        • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
      • Frankfurt am Main, Germany, 60487
        • St. Elisabethen Krankenhaus
      • Großhansdorf, Germany, 22927
        • LungenClinic Grosshansdorf GmbH
      • Halle, Germany, 06120
        • Krankenhaus Martha-Maria; Halle-Dolau gGmbH
      • Hamburg, Germany, 21075
        • Asklepios Klinik Harburg
      • Hemer, Germany, 58675
        • Lungenklinik Hemer
      • Homburg, Germany, 66421
        • Universität Des Saarlandes; Klinik für Innere Medizin V
      • Koln, Germany, 51109
        • Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz
      • Loewenstein, Germany, 74245
        • Klinik Loewenstein gGmbH; Onk & Pal
      • München, Germany, 81925
        • Klinikum Bogenhausen
      • Regensburg, Germany, 93049
        • Krankenhaus Barmherzige Bruder Regensburg
      • Regensburg, Germany, 93053
        • Klinikum der Universität Regensburg
      • Rheine, Germany, 48431
        • Stiftung Mathias-Spital Rheine
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • AORN A Cardarelli
    • Lazio
      • Roma, Lazio, Italy, 00128
        • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
      • Roma, Lazio, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini
      • Roma, Lazio, Italy, 00168
        • Università Cattolica Del S Cuore
    • Liguria
      • Genova, Liguria, Italy, 16132
        • Istituto Nazionale Per La Ricerca Sul Cancro Di Genova
      • Genova, Liguria, Italy, 16147
        • ASL 3 Genovese; DSM
    • Piemonte
      • Novara, Piemonte, Italy, 28100
        • A.O.U. Maggiore della Carità
    • Sardegna
      • Sassari, Sardegna, Italy, 07100
        • Azienda Unita Sanitaria Locale N1 Sassari; Unita Operativa Di Oncologia Medica
    • Sicilia
      • Catania, Sicilia, Italy, 95123
        • Policlinico Vittorio Emanuele
    • Toscana
      • Lido Di Camaiore, Toscana, Italy, 55043
        • Ospedale Versilia
      • Livorno, Toscana, Italy, 57124
        • Ospedale Civile - Livorno
  • Japan
      • Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
      • Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center
      • Fukuoka, Japan, 830-0011
        • Kurume University Hospital
      • Fukuoka, Japan, 811-1395
        • NHO Kyushu Cancer Center
      • Kanagawa, Japan, 252-0375
        • Kitasato University Hospital
      • Kanagawa, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital
      • Miyagi, Japan, 981-1293
        • Miyagi Cancer Center
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Osaka, Japan, 545-8586
        • Osaka City University Hospital
      • Osaka, Japan, 560-8552
        • National Hospital Organization Osaka Toneyama Medical Center
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital
      • Tokyo, Japan, 181-8611
        • Kyorin University Hospital
      • Tokyo, Japan, 162-0052
        • Center Hospital of the National Center for Global Health and Medicine
      • Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital
  • Latvia
      • Riga, Latvia, LV-1079
        • Riga East Clinical University Hospital Latvian Oncology Centre
      • Rīga, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital
  • Lithuania
      • Vilnius, Lithuania, 08660
        • National Cancer Institute
  • Mexico
      • Monterrey, Mexico, 64020
        • Centro Universitario Contra El Cancer
      • Queretaro, Mexico, 76090
        • Cancerologia De Queretaro
      • Toluca, Mexico, 50080
        • Centro Hemato Oncologico Privado; Oncologia
  • Netherlands
      • 'S Hertogenbosch, Netherlands, 5223 GZ
        • Jeroen Bosch Ziekenhuis
      • Amsterdam, Netherlands, 1081 HV
        • Amsterdam UMC Location VUMC
      • Breda, Netherlands, 4818 CK
        • Amphia Ziekenhuis; Afdeling Longziekten
      • EDE, Netherlands, 6716 RP
        • Ziekenhuis Gelderse Vallei
      • Hilversum, Netherlands, 1201 DA
        • Tergooiziekenhuizen
      • Hoofddorp, Netherlands, 2134 TM
        • Spaarne Gasthuis; Spaarne Ziekenhuis
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis; R&D Long
      • Rotterdam, Netherlands, 3079 DZ
        • Maasstad Ziekenhuis
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC; Afdeling Longziekten
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht
      • Zutphen, Netherlands, 7207 AE
        • Gelre Ziekenhuizen, Zutphen
  • Peru
      • Arequipa, Peru, 04001
        • Centro Medico Monte Carmelo
      • Arequipa, Peru
        • Centro Especializado de Enfermedades Neoplasicas
      • Lima, Peru, Lima 34
        • Instituto Nacional de Enfermedades Neoplasicas
  • Portugal
      • Coimbra, Portugal, 3000-602
        • Centro Hospitalar e Universitario de Coimbra EPE
      • Lisboa, Portugal, 1796-001
        • Hospital Pulido Valente; Servico de Pneumologia
      • Lisboa, Portugal, 1099-023
        • Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE
      • Porto, Portugal, 4099-001
        • Centro Hospitalar do Porto - Hospital de Santo Antonio
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
      • Porto, Portugal, 4200
        • Hospital de Sao Joao; Servico de Pneumologia
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Russian Oncology Research Center n.a. N.N. Blokhin
      • Omsk, Russian Federation, 644013
        • Clinical Oncology Dispensary
      • Pushkin, Russian Federation, 196603
        • Evromedservis LCC
      • Saint-Petersburg, Russian Federation, 197022
        • City Clinical Oncology Dispensary
    • Moskovskaja Oblast
      • Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
        • Moscow City Oncology Hospital #62
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre; Medical Oncology
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • Narodny Onkologicky Ustav
      • Bratislava, Slovakia, 813 69
        • Univerzitna nemocnica Bratislava
      • Poprad, Slovakia, 058 01
        • POKO Poprad s.r.o.
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Univ Vall d'Hebron; Servicio de Oncologia
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Lugo, Spain, 27003
        • Hospital Lucus Augusti; Servicio de Oncologia
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal; Servicio de Oncologia
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos; Servicio de Oncologia
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
      • Madrid, Spain, 280146
        • Hospital Universitario La Paz
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro-CIOCC
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia
      • Sabadell, Barcelona, Spain, 8208
        • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain, 07014
        • Hospital Universitario Son Espases
    • LAS Palmas
      • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
        • Hospital Universitario Insular de Gran Canaria
    • Orense
      • Ourense, Orense, Spain, 32005
        • Complejo Hospitalario U. de Ourense
    • Valencia
      • Xativa, Valencia, Spain, 46800
        • Hospital Lluís Alcanyís de Xàtiva
  • Switzerland
      • Bruderholz, Switzerland, 4101
        • Kantonsspital Baselland
      • Luzern, Switzerland, 6000
        • Luzerner Kantonsspital Sursee
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen; Onkologie/Hämatologie
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital; Hematology-Oncology
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Hospital; Department of Urology
      • Liuying Township, Taiwan, 736
        • Chi Mei Medical Center Liou Ying Campus
      • Putzu, Taiwan, 613
        • Chang Gung Memorial Hospital Chiayi
      • Tainan, Taiwan, 00704
        • National Cheng Kung Univ Hosp
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taipei, Taiwan, 112
        • Cheng Hsin General Hospital
      • Taipei City, Taiwan, 10041
        • National Taiwan Uni Hospital
      • Taoyuan City, Taiwan, 333
        • Chang Gung Medical Foundation Linkou Branch
      • Xitun Dist., Taiwan, 40705
        • Taichung Veterans General Hospital
  • Ukraine
      • Kharkiv, Ukraine, 61024
        • SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine
      • Kryvyi Rih, Ukraine, 50048
        • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department
      • Kyiv, Ukraine, 03115
        • Kyiv City Clinical Oncological Center
      • Poltava, Ukraine, 36011
        • Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department
      • Sumy, Ukraine, 40005
        • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
    • Chernihiv Governorate
      • Chernivtsi, Chernihiv Governorate, Ukraine, 58013
        • ME Bukovinian Clinical Oncology Center
    • KIEV Governorate
      • Ivano-Frankivsk, KIEV Governorate, Ukraine, 76018
        • Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2
      • Vinnytsia, KIEV Governorate, Ukraine, 21029
        • Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
    • Katerynoslav Governorate
      • Dnipropetrovsk, Katerynoslav Governorate, Ukraine, 49102
        • Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy
      • Uzhhorod, Katerynoslav Governorate, Ukraine, 88000
        • Uzhgorod Central City Clinical Hospital
      • Zaporizhzhia, Katerynoslav Governorate, Ukraine, 69040
        • MNPE Zaporizhzhia Regional Antitumor Center ZRC
    • Kharkiv Governorate
      • Kharkiv, Kharkiv Governorate, Ukraine, 61070
        • Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs
    • Kherson Governorate
      • Uzhhorod, Kherson Governorate, Ukraine, 88014
        • MNPE Transcarpathian Antitumor Center of the Transcarpathian Regional Council; Chemotherapy Dept
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Cancer & Research Centers
      • Flagstaff, Arizona, United States, 86001
        • Arizona Oncology Associates
    • California
      • Bellflower, California, United States
        • Southern CA Permanente Med Grp
      • Greenbrae, California, United States, 94904
        • Marin Cancer Care Inc
      • La Jolla, California, United States, 92037
        • Scripps Health
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center UCI
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
      • Lonetree, Colorado, United States, 80124
        • Kaiser Permanente
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
      • New Haven, Connecticut, United States, 06520
        • Yale Cancer Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital Inc
      • Jacksonville, Florida, United States, 32258
        • Cancer Specialists of North Florida - Baptist South
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Port Saint Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of the Treasure Coast
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute, PC
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • Univ of Chicago
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, S.C.
    • Iowa
      • Bettendorf, Iowa, United States, 52722
        • Hematology-Oncology; Associates of the Quad Cities
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute
    • Maine
      • Scarborough, Maine, United States, 04074
        • New England Cancer Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Bethesda, Maryland, United States, 20817
        • Regional Cancer Care Associates
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology, P.A.
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • St. Joseph Mercy Health System
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Luke's Regional Cancer Center
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicolett - Frauenshuh Cancer Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Cancer Institute
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
    • Montana
      • Billings, Montana, United States, 59102
        • Billings Clinic
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Berkeley Heights, New Jersey, United States, 07922
        • Summit Medical Group
      • Paramus, New Jersey, United States, 07652
        • Valley Hospital; Oncology Research
      • Sewell, New Jersey, United States, 08080
        • Regional Cancer Care Associates LLC
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • First Health of the Carolinas
    • Ohio
      • Cincinnati, Ohio, United States, 45203-0542
        • University of Cincinnati
      • Toledo, Ohio, United States, 43623
        • Mercy St Anne Hospital
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic
      • Bend, Oregon, United States, 97701
        • St. Charles Medical Center Bend; Cancer Care Of The Cascades
      • Springfield, Oregon, United States, 97477
        • Willamette Valley Cancer Insitute and Research Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Cancer Care Associates
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • Univ of Pittsburgh Medical Ctr
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • West Clinic
      • Knoxville, Tennessee, United States, 37920
        • Tennessee Cancer Specialists
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Cancer Center
      • Longview, Texas, United States, 75601
        • Longview Cancer Center
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Richmond, Virginia, United States, 23226
        • Virginia Cancer Institute
      • Roanoke, Virginia, United States, 24014
        • Blue Ridge Cancer Care
    • Washington
      • Auburn, Washington, United States, 98002-4117
        • MultiCare Regional Cancer Center - Auburn
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University; Mary Babb Randolph Can Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (Atezolizumab+Paclitaxel+Carboplatin)
Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.
Other Names:
  • Tecentriq
  • MPDL3280A
  • RO5541267
Drug: Carboplatin
Carboplatin was administered at area under the concentration-time curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Drug: Paclitaxel
Paclitaxel was administered as IV infusion at a dose of 200 milligrams per square meter (mg/m^2) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Experimental: Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)
Participants received IV infusion of atezolizumab and bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.
Other Names:
  • Tecentriq
  • MPDL3280A
  • RO5541267
Drug: Carboplatin
Carboplatin was administered at area under the concentration-time curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Drug: Paclitaxel
Paclitaxel was administered as IV infusion at a dose of 200 milligrams per square meter (mg/m^2) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Drug: Bevacizumab
Bevacizumab was administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, or death.
Active Comparator: Arm C (Bevacizumab+Paclitaxel+Carboplatin)
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
Drug: Carboplatin
Carboplatin was administered at area under the concentration-time curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Drug: Paclitaxel
Paclitaxel was administered as IV infusion at a dose of 200 milligrams per square meter (mg/m^2) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Drug: Bevacizumab
Bevacizumab was administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, or death.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population
Time Frame: Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)
Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.
Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)
Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population
Time Frame: Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)
Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population
Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)
Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population
Time Frame: Baseline until death (up approximately 53 months)
Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population
Baseline until death (up approximately 53 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population
Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
PFS, as determined by the independent review facility (IRF) Using RECIST v1.1 in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population.
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population
Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
PFS, as determined by the investigator according to RECIST v1.1, in Arm B versus C in the Teff high population and ITT population.
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
PFS, as determined by the investigator according to RECIST v1.1, in Arm A versus B in the Teff high-WT population and ITT-WT population.
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
PFS, as Determined by the Investigator in Arm B Versus Arm C by PD-L1 Subgroup
Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
PFS as Determined by the Investigator according to RECIST v1.1, in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
OS in Arm B Versus Arm C by PD-L1 Subgroup
Time Frame: Baseline until death (up to approximately 34 months)
OS in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)
Baseline until death (up to approximately 34 months)
OS in Arm A Versus Arm C by PD-L1 Subgroup
Time Frame: Baseline until death (up approximately 53 months)
OS in Arm A Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)
Baseline until death (up approximately 53 months)
OS in Arm B Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
Time Frame: Baseline until death (up to approximately 34 months)
Baseline until death (up to approximately 34 months)
OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population
Time Frame: Baseline until death (up approximately 53 months)
Baseline until death (up approximately 53 months)
OS in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population
Time Frame: Baseline until death (up approximately 53 months)
Baseline until death (up approximately 53 months)
Duration of Response (DOR), as Determined By Investigator in Arm B Versus Arm C
Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
DOR, as determined by investigator according to RECIST v1.1 in Arm B versus Arm C in the Teff high-WT population and the ITT-WT population.
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator in the Teff-High-WT Population and ITT-WT Population
Time Frame: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator using RECIST v1.1 in the Teff-High-WT population and ITT-WT population.
Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)
OS Rates at Years 1 and 2 in Arm B Versus Arm C
Time Frame: Baseline to 2 years or death, whichever occurs first.
OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.
Baseline to 2 years or death, whichever occurs first.
OS Rates at Years 1 and 2 in Arm A Versus Arm C
Time Frame: Baseline to 2 years or death, whichever occurs first.
OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.
Baseline to 2 years or death, whichever occurs first.
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score
Time Frame: Baseline up to approximately 29 months
EORTC QLQ-C30 is a validated & reliable self-report measure (Aaronson et al.1993;Fitzsimmons et al.1999) that consists of 30 questions that assess 5 aspects of patient functioning (physical,emotional,role, cognitive,and social), 3 symptom scales (fatigue,nausea & vomiting, pain),global health/quality of life,and six single items (dyspnea,insomnia, appetite loss,constipation,diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life);however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al.1998).
Baseline up to approximately 29 months
TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score
Time Frame: Baseline up to approximately 29 months
QLQ-LC13 Quality-of-Life Questionnaire Lung Cancer Module incorporates one multiple-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).
Baseline up to approximately 29 months
Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale
Time Frame: Baseline up to approximately 29 months
The SILC (Symptoms in Lung Cancer) scale was used to assess patient-reported severity of lung cancer symptoms (chest pain, dyspnea, and cough). The SILC scale is a 9-item content validated self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a symptom severity score. The SILC questionnaire comprises three individual symptoms (dyspnea, cough, chest pain) and are scored at the individual symptom level, thus have a dyspnea score, chest pain score, and cough score. Each individual symptom score is calculated as the average of responses for the symptom items [e.g. Chest Pain Score=mean (item 1; item 2)]. An increase in score is suggestive of a worsening in symptomology (i.e. frequency or severity). A score change of ≥0.3 points for the dyspnea and cough symptom scores is considered to be clinically significant; whereas a score change of ≥0.5 points for the chest pain score is considered to be clinically significant.
Baseline up to approximately 29 months
Percentage of Participants With Adverse Events
Time Frame: Baseline up to data cutoff date 7 December 2020 (up to approximately 68 months)
Percentage of participants with at least one adverse event.
Baseline up to data cutoff date 7 December 2020 (up to approximately 68 months)
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Time Frame: Baseline up to approximately 29 months
Baseline up to approximately 29 months
Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Arm A and Arm B
Time Frame: Day 1 of Cycle 1 and 3 (Cycle length=21 days)
The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.
Day 1 of Cycle 1 and 3 (Cycle length=21 days)
Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B
Time Frame: Day 21 of Cycles 1, 2 3, and 7 (Cycle length=21 days)
Day 21 of Cycles 1, 2 3, and 7 (Cycle length=21 days)
Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C
Time Frame: Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 h after carboplatin infusion (infusion duration=15 to 30 minutes) on D1 of Cy1,3 (Cycle length=21 days)
Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 h after carboplatin infusion (infusion duration=15 to 30 minutes) on D1 of Cy1,3 (Cycle length=21 days)
Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C
Time Frame: Predose (same day of treatment administration), 5-10 minutes before end of paclitaxel infusion, 1 h after paclitaxel infusion (infusion duration=3 h) on D1 of Cy1,3 (Cycle length=21 days)
Predose (same day of treatment administration), 5-10 minutes before end of paclitaxel infusion, 1 h after paclitaxel infusion (infusion duration=3 h) on D1 of Cy1,3 (Cycle length=21 days)
Cmax of Bevacizumab in Arm B and Arm C
Time Frame: Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length=21 days)
Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length=21 days)
Cmin of Bevacizumab in Arm B and Arm C
Time Frame: Cycle 1 Day 1 and Cycle 2 Day 21 (Cycle length=21 days)
Cycle 1 Day 1 and Cycle 2 Day 21 (Cycle length=21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2015

Primary Completion (Actual)

September 13, 2019

Study Completion (Actual)

December 7, 2020

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 12, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

August 26, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO29436
  • 2014-003207-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carcinoma, Non-Small-Cell Lung

Clinical Trials on Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe