AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3IMpower150NCT02366143

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)

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Bevacizumab and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 240 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Bevacizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,202 participants
Where
240 sitesin 26 countries
Study dates
31 Mar 2015to 7 Dec 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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
  • Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies

Trial locations and contacts

240 sites in 26 countries.

240 sites in 26 countries

United States61 sites

  • St. Joseph Mercy Health System

    Ann Arbor, Michigan, 48106

  • Piedmont Cancer Institute, PC

    Atlanta, Georgia, 30318

  • MultiCare Regional Cancer Center - Auburn

    Auburn, Washington, 98002-4117

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Southern CA Permanente Med Grp

    Bellflower, California

  • Bend Memorial Clinic

    Bend, Oregon, 97701

  • St. Charles Medical Center Bend; Cancer Care Of The Cascades

    Bend, Oregon, 97701

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Regional Cancer Care Associates

    Bethesda, Maryland, 20817

  • St. Luke's Cancer Care Associates

    Bethlehem, Pennsylvania, 18015

  • Hematology-Oncology; Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • Billings Clinic

    Billings, Montana, 59102

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Univ of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45203-0542

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • St. Luke's Regional Cancer Center

    Duluth, Minnesota, 55805

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Arizona Oncology Associates

    Flagstaff, Arizona, 86001

  • Holy Cross Hospital Inc

    Fort Lauderdale, Florida, 33308

  • West Clinic

    Germantown, Tennessee, 38138

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89014

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • Cancer Specialists of North Florida - Baptist South

    Jacksonville, Florida, 32258

  • St. Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37920

  • Scripps Health

    La Jolla, California, 92037

  • Kaiser Permanente

    Lonetree, Colorado, 80124

  • Longview Cancer Center

    Longview, Texas, 75601

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • West Virginia University; Mary Babb Randolph Can Ctr

    Morgantown, West Virginia, 26506

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Chao Family Comprehensive Cancer Center UCI

    Orange, California, 92868

  • Valley Hospital; Oncology Research

    Paramus, New Jersey, 07652

  • Oncology Specialists, S.C.

    Park Ridge, Illinois, 60068

  • First Health of the Carolinas

    Pinehurst, North Carolina, 28374

  • Allegheny Cancer Center

    Pittsburgh, Pennsylvania, 15212

  • Univ of Pittsburgh Medical Ctr

    Pittsburgh, Pennsylvania, 15232

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Virginia Cancer Institute

    Richmond, Virginia, 23226

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Park Nicolett - Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Regional Cancer Care Associates LLC

    Sewell, New Jersey, 08080

  • Medical Oncology Associates

    Spokane, Washington, 99208

  • Willamette Valley Cancer Insitute and Research Center

    Springfield, Oregon, 97477

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Mercy St Anne Hospital

    Toledo, Ohio, 43623

Other trials in United States

Spain20 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, LAS Palmas, 35016

  • Hospital Lucus Augusti; Servicio de Oncologia

    Lugo, 27003

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Hospital Universitario La Paz

    Madrid, 280146

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Clinico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Hospital Universitario Fundación Jimenez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro-CIOCC

    Madrid, 28050

  • Complejo Hospitalario U. de Ourense

    Ourense, Orense, 32005

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07014

  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

    Sabadell, Barcelona, 8208

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Lluis Alcanyis De Xativa

    Xàtiva, Valencia, 46800

Other trials in Spain

Germany17 sites

  • Zentralklinikum Augsburg

    Augsburg, 86156

  • Helios Klinikum Emil von Behring GmbH

    Berlin, 14165

  • Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie

    Bielefeld, 33611

  • Augusta Kranken-Anstalt gGmbH

    Bochum, 44791

  • Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz

    Cologne, 51109

  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

    Dresden, 01307

  • St. Elisabethen Krankenhaus

    Frankfurt am Main, 60487

  • LungenClinic Großhansdorf GmbH

    Großhansdorf, 22927

  • Krankenhaus Martha-Maria; Halle-Dolau gGmbH

    Halle, 06120

  • Asklepios Klinik Harburg

    Hamburg, 21075

  • Lungenklinik Hemer

    Hemer, 58675

  • Universität Des Saarlandes; Klinik für Innere Medizin V

    Homburg, 66421

  • Klinik Loewenstein gGmbH; Onk & Pal

    Löwenstein, 74245

  • Klinikum Bogenhausen

    München, 81925

  • Krankenhaus Barmherzige Bruder Regensburg

    Regensburg, 93049

  • Klinikum der Universität Regensburg

    Regensburg, 93053

  • Stiftung Mathias-Spital Rheine

    Rheine, 48431

Other trials in Germany

Australia16 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Prince Charles Hospital; Department of Medical Oncology

    Chermside, Queensland, 4032

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Adelaide Cancer Centre

    Kurralta Park, South Australia, 5037

  • Launceston General Hospital

    Launceston, Tasmania, 7250

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • The Alfred Hospital

    Prahan, Victoria, 3181

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Nepean Cancer Care Centre

    Sydney, New South Wales, 2747

  • Townsville Hospital

    Townsville, Queensland, 4810

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Japan15 sites

  • National Hospital Organization Shikoku Cancer Center

    Ehime, 791-0280

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

  • NHO Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kurume University Hospital

    Fukuoka, 830-0011

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, 236-0051

  • Kitasato University Hospital

    Kanagawa, 252-0375

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Miyagi Cancer Center

    Miyagi, 981-1293

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Osaka City University Hospital

    Osaka, 545-8586

  • National Hospital Organization Osaka Toneyama Medical Center

    Osaka, 560-8552

  • Toranomon Hospital

    Tokyo, 105-8470

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo, 162-0052

  • Kyorin University Hospital

    Tokyo, 181-8611

  • Wakayama Medical University Hospital

    Wakayama, 641-8510

Other trials in Japan

Ukraine13 sites

  • ME Bukovinian Clinical Oncology Center

    Chernivtsi, Chernihiv Governorate, 58013

  • Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy

    Dnipropetrovsk, Katerynoslav Governorate, 49102

  • Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2

    Ivano-Frankivsk, KIEV Governorate, 76018

  • Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

    Kharkiv, Kharkiv Governorate, 61070

  • SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine

    Kharkiv, 61024

  • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

    Kryvyi Rih, 50048

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115

  • Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department

    Poltava, 36011

  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

    Sumy, 40005

  • Uzhgorod Central City Clinical Hospital

    Uzhhorod, Katerynoslav Governorate, 88000

  • MNPE Transcarpathian Antitumor Center of the Transcarpathian Regional Council; Chemotherapy Dept

    Uzhhorod, Kherson Governorate, 88014

  • Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

    Vinnytsia, KIEV Governorate, 21029

  • MNPE Zaporizhzhia Regional Antitumor Center ZRC

    Zaporizhzhya, Katerynoslav Governorate, 69040

Other trials in Ukraine

France12 sites

  • Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

    Bordeaux, 33076

  • CHU de Grenoble

    Grenoble, 38043

  • Centre Jean Bernard Clinique Victor Hugo

    Le Mans, 72015

  • Hôpital Saint Joseph

    Marseille, 13008

  • Hopital Nord AP-HM

    Marseille, 13015

  • Hôpital Européen Georges Pompidou

    Paris, 75908

  • CHU de Bordeaux

    Pessac, 33600

  • Service de Pneumologie Centre Hospitalier Régional La Réunion Site Felix Guyon

    Saint-Denis, 97405

  • CH de Saint Quentin

    Saint-Quentin, 2100

  • Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

    Toulon, 83000

  • Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie

    Toulon, 83000

  • Hôpital Larrey;Université Paul Sabatier

    Toulouse, 31059

Other trials in France

Netherlands12 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Amsterdam UMC Location VUMC

    Amsterdam, 1081 HV

  • Amphia Ziekenhuis; Afdeling Longziekten

    Breda, 4818 CK

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP

  • Tergooiziekenhuizen

    Hilversum, 1201 DA

  • Spaarne Gasthuis; Spaarne Ziekenhuis

    Hoofddorp, 2134 TM

  • Maastricht University Medical Center

    Maastricht, 6229 HX

  • St. Antonius Ziekenhuis; R&D Long

    Nieuwegein, 3435 CM

  • Erasmus MC; Afdeling Longziekten

    Rotterdam, 3015 GD

  • Maasstad ziekenhuis

    Rotterdam, 3079 DZ

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

  • Gelre Ziekenhuizen, Zutphen

    Zutphen, 7207 AE

Other trials in Netherlands

Italy11 sites

  • Policlinico Vittorio Emanuele

    Catania, Sicily, 95123

  • Istituto Nazionale per la Ricerca sul Cancro di Genova

    Genoa, Liguria, 16132

  • ASL 3 Genovese; DSM

    Genoa, Liguria, 16147

  • Ospedale Versilia

    Lido di Camaiore, Tuscany, 55043

  • Ospedale Civile - Livorno

    Livorno, Tuscany, 57124

  • AORN A Cardarelli

    Naples, Campania, 80131

  • A.O.U. Maggiore della Carità

    Novara, Piedmont, 28100

  • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

    Rome, Lazio, 00128

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00152

  • Università Cattolica Del S Cuore

    Rome, Lazio, 00168

  • Azienda Unita Sanitaria Locale N1 Sassari; Unita Operativa Di Oncologia Medica

    Sassari, Sardinia, 07100

Other trials in Italy

Taiwan10 sites

  • Changhua Christian Hospital; Hematology-Oncology

    Changhua, 500

  • Kaohsiung Medical University Hospital; Department of Urology

    Kaohsiung City, 807

  • Chi Mei Medical Center Liou Ying Campus

    Liuying Township, 736

  • Chang Gung Memorial Hospital Chiayi

    Putzu, 613

  • National Cheng Kung Univ Hosp

    Tainan, 00704

  • National Taiwan Uni Hospital

    Taipei, 10041

  • Cheng Hsin General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 11490

  • Chang Gung Medical Foundation Linkou Branch

    Taoyuan City, 333

  • Taichung Veterans General Hospital

    Xitun Dist., 40705

Other trials in Taiwan

Brazil9 sites

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • IPCEM; Instituto de Pesquisa de Estudos Multicêntricos

    Caxias do Sul, Rio Grande do Sul, 95070-560

  • Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica

    Londrina, Paraná, 86 015 520

  • Liga Norte Riograndense Contra O Câncer

    Natal, Rio Grande do Norte, 59040150

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90470-340

  • Instituto Ribeirãopretano de Combate Ao Câncer; Centro Especializado De Oncologia

    Ribeirão Preto, São Paulo, 14015-130

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Hospital A. C. Camargo; Oncologia

    São Paulo, São Paulo, 01509-010

  • CETUS Hospital Dia Oncologia

    Uberaba, Minas Gerais, 38082-049

Other trials in Brazil

Argentina7 sites

  • Centro Medico Austral

    Buenos Aires, 1019

  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD

  • Sanatorio Allende

    Córdoba, X5000JHQ

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

  • Hospital Provincial del Centenario

    Rosario, 2000

  • Fundacion Koriza

    Santa Rosa, 6300

  • Centro de Investigacion; Clinica - Clinica Viedma S.A.

    Viedma, R8500ACE

Other trials in Argentina

Portugal6 sites

  • Centro Hospitalar E Universitário de Coimbra EPE

    Coimbra, 3000-602

  • Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE

    Lisbon, 1099-023

  • Hospital Pulido Valente; Servico de Pneumologia

    Lisbon, 1796-001

  • Centro Hospitalar do Porto - Hospital de Santo António

    Porto, 4099-001

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

    Porto, 4200-072

  • Hospital de Sao Joao; Servico de Pneumologia

    Porto, 4200

Other trials in Portugal

Russia5 sites

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • Russian Oncology Research Center n.a. N.N. Blokhin

    Moscow, 115478

  • Clinical Oncology Dispensary

    Omsk, 644013

  • Evromedservis LCC

    Pushkin, 196603

  • City Clinical Oncology Dispensary

    Saint Petersburg, 197022

Other trials in Russia

Chile3 sites

  • Clinica Santa Maria

    Santiago, 0

  • Health & Care SPA

    Santiago, 7500006

  • Sociedad de Investigaciones Medicas Ltda (SIM)

    Temuco, 4810469

Other trials in Chile

Mexico3 sites

  • Centro Universitario Contra El Cancer

    Monterrey, 64020

  • Cancerologia de Queretaro

    Querétaro, 76090

  • Centro Hemato Oncologico Privado; Oncologia

    Toluca, 50080

Other trials in Mexico

Peru3 sites

  • Centro Medico Monte Carmelo

    Arequipa, 04001

  • Centro Especializado de Enfermedades Neoplásicas

    Arequipa

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34

Other trials in Peru

Slovakia3 sites

  • Univerzitna nemocnica Bratislava

    Bratislava, 813 69

  • Narodny onkologicky ustav

    Bratislava, 833 10

  • POKO Poprad s.r.o.

    Poprad, 058 01

Other trials in Slovakia

Switzerland3 sites

  • Kantonsspital Baselland

    Bruderholz, 4101

  • Luzerner Kantonsspital Sursee

    Lucerne, 6000

  • Kantonsspital St. Gallen; Onkologie/Hämatologie

    Sankt Gallen, 9007

Other trials in Switzerland

Austria2 sites

  • Paracelsus Medizinische Privatuniversität

    Salzburg, 5020

  • Klinikum Wels-Grieskirchen

    Wels, 4600

Other trials in Austria

Belgium2 sites

  • CHU de Liège

    Liège, 4000

  • Clinique Ste-Elisabeth

    Namur, 5000

Other trials in Belgium

Bulgaria2 sites

  • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

    Plovdiv, 4000

  • MHAT Serdika, EOOD

    Sofia, 1303

Other trials in Bulgaria

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

  • Riga East Clinical University Hospital Latvian Oncology Centre

    Riga, LV-1079

Other trials in Latvia

Canada1 site

  • Lakeridge Health Center

    Oshawa, Ontario, L1J 2J2

Other trials in Canada

Lithuania1 site

  • National Cancer Institute

    Vilnius, 08660

Other trials in Lithuania

Singapore1 site

  • National Cancer Centre; Medical Oncology

    Singapore, 169610

Other trials in Singapore

About this study

Official title: 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).

Being tested
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Bevacizumab, Carboplatin, Paclitaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibodyDrug

    Also called MPDL3280A, RO5541267, Tecentriq

    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.

  • BevacizumabDrug

    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.

  • CarboplatinDrug

    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.

  • PaclitaxelDrug

    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.

Study groups in NCT02366143
Study groupRoleWhat they receive
Arm A (Atezolizumab+Paclitaxel+Carboplatin)ExperimentalParticipants 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.
Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Carboplatin; Drug: Paclitaxel
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)ExperimentalParticipants 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.
Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel
Arm C (Bevacizumab+Paclitaxel+Carboplatin)Active comparatorParticipants 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.
Receives: Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)

  2. Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population

    Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population

    Measured: Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)

  3. Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population

    Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population

    Measured: Baseline until death (up approximately 53 months)

Secondary outcomes (24)

  1. PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population

    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.

    Measured: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

  2. PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population

    PFS, as determined by the investigator according to RECIST v1.1, in Arm B versus C in the Teff high population and ITT population.

    Measured: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

  3. PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population

    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.

    Measured: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

  4. PFS, as Determined by the Investigator in Arm B Versus Arm C by PD-L1 Subgroup

    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)

    Measured: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

  5. OS in Arm B Versus Arm C by PD-L1 Subgroup

    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)

    Measured: Baseline until death (up to approximately 34 months)

  6. OS in Arm A Versus Arm C by PD-L1 Subgroup

    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)

    Measured: Baseline until death (up approximately 53 months)

  7. OS in Arm B Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population

    Measured: Baseline until death (up to approximately 34 months)

  8. OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population

    Measured: Baseline until death (up approximately 53 months)

  9. OS in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population

    Measured: Baseline until death (up approximately 53 months)

  10. Duration of Response (DOR), as Determined By Investigator in Arm B Versus Arm C

    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.

    Measured: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

  11. 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

    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.

    Measured: Baseline until disease progression or death, whichever occurs first (up to approximately 29 months)

  12. OS Rates at Years 1 and 2 in Arm B Versus Arm C

    OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.

    Measured: Baseline to 2 years or death, whichever occurs first.

  13. OS Rates at Years 1 and 2 in Arm A Versus Arm C

    OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population.

    Measured: Baseline to 2 years or death, whichever occurs first.

  14. 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

    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).

    Measured: Baseline up to approximately 29 months

  15. TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score

    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).

    Measured: Baseline up to approximately 29 months

  16. Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale

    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.

    Measured: Baseline up to approximately 29 months

  17. Percentage of Participants With Adverse Events

    Percentage of participants with at least one adverse event.

    Measured: Baseline up to data cutoff date 7 December 2020 (up to approximately 68 months)

  18. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

    Measured: Baseline up to approximately 29 months

  19. Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Arm A and Arm B

    The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.

    Measured: Day 1 of Cycle 1 and 3 (Cycle length=21 days)

  20. Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B

    Measured: Day 21 of Cycles 1, 2 3, and 7 (Cycle length=21 days)

  21. Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C

    Measured: 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)

  22. Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C

    Measured: 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)

  23. Cmax of Bevacizumab in Arm B and Arm C

    Measured: Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length=21 days)

  24. Cmin of Bevacizumab in Arm B and Arm C

    Measured: Cycle 1 Day 1 and Cycle 2 Day 21 (Cycle length=21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2015 (estimated)
  2. Study start31 Mar 2015
  3. Primary completion13 Sep 2019
  4. Study completion7 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02366143
Sponsor's protocol ID
GO29436
Other IDs
2014-003207-30, 2014
Acronym
IMpower150
Status last verified
Aug 2021
First submitted
12 Feb 2015
Last updated
23 Sep 2021

Publications

  • Zhou C, Dong X, Chen G, Wang Z, Wu X, Yao Y, Zhang Y, Cheng Y, Pan H, Zhang X, Cui J, Wang L, Chen X, Li X, Wang Z, Wang Q, He J, Wang M, Yan I, Qian L, Xu M, Huang X, Sun C, Cai J, Wu Q, Ballinger M, Kaul M, Srivastava MK. Atezolizumab plus bevacizumab and chemotherapy in metastatic nonsquamous NSCLC: the randomized double-blind phase 3 IMpower151 trial. Nat Med. 2025 Jul;31(7):2375-2384. doi: 10.1038/s41591-025-03658-y. Epub 2025 May 16.

    PubMed 40379995

  • Mang A, Zou W, Rolny V, Reck M, Cigoianu D, Schulze K, Holdenrieder S, Socinski MA, Shames DS, Wehnl B, Patil NS. Combined use of CYFRA 21-1 and CA 125 predicts survival of patients with metastatic NSCLC and stable disease in IMpower150. Tumour Biol. 2024;46(s1):S177-S190. doi: 10.3233/TUB-230001.

    PubMed 37545290

  • Socinski MA, Jotte RM, Cappuzzo F, Nishio M, Mok TSK, Reck M, Finley GG, Kaul MD, Yu W, Paranthaman N, Bara I, West HJ. Association of Immune-Related Adverse Events With Efficacy of Atezolizumab in Patients With Non-Small Cell Lung Cancer: Pooled Analyses of the Phase 3 IMpower130, IMpower132, and IMpower150 Randomized Clinical Trials. JAMA Oncol. 2023 Apr 1;9(4):527-535. doi: 10.1001/jamaoncol.2022.7711.

    PubMed 36795388

  • Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.

    PubMed 35511917

  • Nogami N, Barlesi F, Socinski MA, Reck M, Thomas CA, Cappuzzo F, Mok TSK, Finley G, Aerts JG, Orlandi F, Moro-Sibilot D, Jotte RM, Stroyakovskiy D, Villaruz LC, Rodriguez-Abreu D, Wan-Teck Lim D, Merritt D, Coleman S, Lee A, Shankar G, Yu W, Bara I, Nishio M. IMpower150 Final Exploratory Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in Key NSCLC Patient Subgroups With EGFR Mutations or Metastases in the Liver or Brain. J Thorac Oncol. 2022 Feb;17(2):309-323. doi: 10.1016/j.jtho.2021.09.014. Epub 2021 Oct 7.

    PubMed 34626838

  • Socinski MA, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kong S, Lee A, Coleman S, Zou W, McCleland M, Shankar G, Reck M. IMpower150 Final Overall Survival Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Nonsquamous NSCLC. J Thorac Oncol. 2021 Nov;16(11):1909-1924. doi: 10.1016/j.jtho.2021.07.009. Epub 2021 Jul 24.

    PubMed 34311108

  • Reck M, Wehler T, Orlandi F, Nogami N, Barone C, Moro-Sibilot D, Shtivelband M, Gonzalez Larriba JL, Rothenstein J, Fruh M, Yu W, Deng Y, Coleman S, Shankar G, Patel H, Kelsch C, Lee A, Piault E, Socinski MA. Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer. J Clin Oncol. 2020 Aug 1;38(22):2530-2542. doi: 10.1200/JCO.19.03158. Epub 2020 May 27.

    PubMed 32459597

  • Reck M, Mok TSK, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Lee A, Coleman S, Deng Y, Kowanetz M, Shankar G, Lin W, Socinski MA; IMpower150 Study Group. Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial. Lancet Respir Med. 2019 May;7(5):387-401. doi: 10.1016/S2213-2600(19)30084-0. Epub 2019 Mar 25.

    PubMed 30922878

  • Socinski MA, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kelsch C, Lee A, Coleman S, Deng Y, Shen Y, Kowanetz M, Lopez-Chavez A, Sandler A, Reck M; IMpower150 Study Group. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med. 2018 Jun 14;378(24):2288-2301. doi: 10.1056/NEJMoa1716948. Epub 2018 Jun 4.

    PubMed 29863955

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Bevacizumab and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 240 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 240 sites in United States, Spain, Germany, Australia, Japan and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02366143, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.

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