NCT02366143

Brief 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).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,202

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_3

Geographic Reach
25 countries

224 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 31, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 27, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2020

Completed
Last Updated

September 23, 2021

Status Verified

August 1, 2021

Enrollment Period

4.5 years

First QC Date

February 12, 2015

Results QC Date

August 21, 2020

Last Update Submit

August 26, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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

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

    Baseline until death (up approximately 53 months)

Secondary Outcomes (24)

  • PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in 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 in 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

    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

    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

    Baseline until death (up to approximately 34 months)

  • +19 more secondary outcomes

Study Arms (3)

Arm A (Atezolizumab+Paclitaxel+Carboplatin)

EXPERIMENTAL

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 antibodyDrug: CarboplatinDrug: Paclitaxel

Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)

EXPERIMENTAL

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 antibodyDrug: BevacizumabDrug: CarboplatinDrug: Paclitaxel

Arm C (Bevacizumab+Paclitaxel+Carboplatin)

ACTIVE COMPARATOR

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: BevacizumabDrug: CarboplatinDrug: Paclitaxel

Interventions

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.

Also known as: MPDL3280A, RO5541267, Tecentriq
Arm A (Atezolizumab+Paclitaxel+Carboplatin)Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)

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.

Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)Arm C (Bevacizumab+Paclitaxel+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.

Arm A (Atezolizumab+Paclitaxel+Carboplatin)Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)Arm C (Bevacizumab+Paclitaxel+Carboplatin)

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.

Arm A (Atezolizumab+Paclitaxel+Carboplatin)Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)Arm C (Bevacizumab+Paclitaxel+Carboplatin)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (240)

Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States

Location

Arizona Oncology Associates

Flagstaff, Arizona, 86001, United States

Location

Southern CA Permanente Med Grp

Bellflower, California, United States

Location

Marin Cancer Care Inc

Greenbrae, California, 94904, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

Chao Family Comprehensive Cancer Center UCI

Orange, California, 92868, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Kaiser Permanente

Lonetree, Colorado, 80124, United States

Location

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Holy Cross Hospital Inc

Fort Lauderdale, Florida, 33308, United States

Location

Cancer Specialists of North Florida - Baptist South

Jacksonville, Florida, 32258, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Piedmont Cancer Institute, PC

Atlanta, Georgia, 30318, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Univ of Chicago

Chicago, Illinois, 60637, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Oncology Specialists, S.C.

Park Ridge, Illinois, 60068, United States

Location

Hematology-Oncology; Associates of the Quad Cities

Bettendorf, Iowa, 52722, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

New England Cancer Specialists

Scarborough, Maine, 04074, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Regional Cancer Care Associates

Bethesda, Maryland, 20817, United States

Location

Maryland Oncology Hematology, P.A.

Columbia, Maryland, 21044, United States

Location

St. Joseph Mercy Health System

Ann Arbor, Michigan, 48106, United States

Location

St. Luke's Regional Cancer Center

Duluth, Minnesota, 55805, United States

Location

Park Nicolett - Frauenshuh Cancer Center

Saint Louis Park, Minnesota, 55426, United States

Location

St. Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Billings Clinic

Billings, Montana, 59102, United States

Location

Montana Cancer Specialists

Missoula, Montana, 59802, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89014, United States

Location

Summit Medical Group

Berkeley Heights, New Jersey, 07922, United States

Location

Valley Hospital; Oncology Research

Paramus, New Jersey, 07652, United States

Location

Regional Cancer Care Associates LLC

Sewell, New Jersey, 08080, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

First Health of the Carolinas

Pinehurst, North Carolina, 28374, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45203-0542, United States

Location

Mercy St Anne Hospital

Toledo, Ohio, 43623, United States

Location

Bend Memorial Clinic

Bend, Oregon, 97701, United States

Location

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

Bend, Oregon, 97701, United States

Location

Willamette Valley Cancer Insitute and Research Center

Springfield, Oregon, 97477, United States

Location

St. Luke's Cancer Care Associates

Bethlehem, Pennsylvania, 18015, United States

Location

Allegheny Cancer Center

Pittsburgh, Pennsylvania, 15212, United States

Location

Univ of Pittsburgh Medical Ctr

Pittsburgh, Pennsylvania, 15232, United States

Location

West Clinic

Germantown, Tennessee, 38138, United States

Location

Tennessee Cancer Specialists

Knoxville, Tennessee, 37920, United States

Location

Houston Methodist Cancer Center

Houston, Texas, 77030, United States

Location

Longview Cancer Center

Longview, Texas, 75601, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23226, United States

Location

Blue Ridge Cancer Care

Roanoke, Virginia, 24014, United States

Location

MultiCare Regional Cancer Center - Auburn

Auburn, Washington, 98002-4117, United States

Location

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Medical Oncology Associates

Spokane, Washington, 99208, United States

Location

West Virginia University; Mary Babb Randolph Can Ctr

Morgantown, West Virginia, 26506, United States

Location

Centro Medico Austral

Buenos Aires, 1019, Argentina

Location

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, C1125ABD, Argentina

Location

Sanatorio Allende

Córdoba, X5000JHQ, Argentina

Location

Centro Oncologico Riojano Integral (CORI)

La Rioja, F5300COE, Argentina

Location

Hospital Provincial del Centenario

Rosario, 2000, Argentina

Location

Fundacion Koriza

Santa Rosa, 6300, Argentina

Location

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

Viedma, R8500ACE, Argentina

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Nepean Cancer Care Centre

Sydney, New South Wales, 2747, Australia

Location

Prince Charles Hospital; Department of Medical Oncology

Chermside, Queensland, 4032, Australia

Location

Townsville Hospital

Townsville, Queensland, 4810, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Adelaide Cancer Centre

Kurralta Park, South Australia, 5037, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Launceston General Hospital

Launceston, Tasmania, 7250, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Cabrini Hospital Malvern

Malvern, Victoria, 3144, Australia

Location

The Alfred Hospital

Prahan, Victoria, 3181, Australia

Location

Sunshine Hospital

St Albans, Victoria, 3021, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Paracelsus Medizinische Privatuniversität

Salzburg, 5020, Austria

Location

Klinikum Wels-Grieskirchen

Wels, 4600, Austria

Location

CHU de Liège

Liège, 4000, Belgium

Location

Clinique Ste-Elisabeth

Namur, 5000, Belgium

Location

CETUS Hospital Dia Oncologia

Uberaba, Minas Gerais, 38082-049, Brazil

Location

Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica

Londrina, Paraná, 86 015 520, Brazil

Location

Liga Norte Riograndense Contra O Câncer

Natal, Rio Grande do Norte, 59040150, Brazil

Location

IPCEM; Instituto de Pesquisa de Estudos Multicêntricos

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

Location

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, 90470-340, Brazil

Location

Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Instituto Ribeirãopretano de Combate Ao Câncer; Centro Especializado De Oncologia

Ribeirão Preto, São Paulo, 14015-130, Brazil

Location

Hospital de Base de Sao Jose do Rio Preto

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

Location

Hospital A. C. Camargo; Oncologia

São Paulo, São Paulo, 01509-010, Brazil

Location

Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

Plovdiv, 4000, Bulgaria

Location

MHAT Serdika, EOOD

Sofia, 1303, Bulgaria

Location

Lakeridge Health Center

Oshawa, Ontario, L1J 2J2, Canada

Location

Clinica Santa Maria

Santiago, 0, Chile

Location

Health & Care SPA

Santiago, 7500006, Chile

Location

Sociedad de Investigaciones Medicas Ltda (SIM)

Temuco, 4810469, Chile

Location

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

Bordeaux, 33076, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Centre Jean Bernard Clinique Victor Hugo

Le Mans, 72015, France

Location

Hôpital Saint Joseph

Marseille, 13008, France

Location

Hopital Nord AP-HM

Marseille, 13015, France

Location

Hôpital Européen Georges Pompidou

Paris, 75908, France

Location

CHU de Bordeaux

Pessac, 33600, France

Location

Service de Pneumologie Centre Hospitalier Régional La Réunion Site Felix Guyon

Saint-Denis, 97405, France

Location

CH de Saint Quentin

Saint-Quentin, 2100, France

Location

Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

Toulon, 83000, France

Location

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

Toulon, 83000, France

Location

Hôpital Larrey;Université Paul Sabatier

Toulouse, 31059, France

Location

Zentralklinikum Augsburg

Augsburg, 86156, Germany

Location

Helios Klinikum Emil von Behring GmbH

Berlin, 14165, Germany

Location

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

Bielefeld, 33611, Germany

Location

Augusta Kranken-Anstalt gGmbH

Bochum, 44791, Germany

Location

Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz

Cologne, 51109, Germany

Location

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, 01307, Germany

Location

St. Elisabethen Krankenhaus

Frankfurt am Main, 60487, Germany

Location

LungenClinic Großhansdorf GmbH

Großhansdorf, 22927, Germany

Location

Krankenhaus Martha-Maria; Halle-Dolau gGmbH

Halle, 06120, Germany

Location

Asklepios Klinik Harburg

Hamburg, 21075, Germany

Location

Lungenklinik Hemer

Hemer, 58675, Germany

Location

Universität Des Saarlandes; Klinik für Innere Medizin V

Homburg, 66421, Germany

Location

Klinik Loewenstein gGmbH; Onk & Pal

Löwenstein, 74245, Germany

Location

Klinikum Bogenhausen

München, 81925, Germany

Location

Krankenhaus Barmherzige Bruder Regensburg

Regensburg, 93049, Germany

Location

Klinikum der Universität Regensburg

Regensburg, 93053, Germany

Location

Stiftung Mathias-Spital Rheine

Rheine, 48431, Germany

Location

AORN A Cardarelli

Napoli, Campania, 80131, Italy

Location

Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

Rome, Lazio, 00128, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, 00152, Italy

Location

Università Cattolica Del S Cuore

Rome, Lazio, 00168, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro di Genova

Genoa, Liguria, 16132, Italy

Location

ASL 3 Genovese; DSM

Genoa, Liguria, 16147, Italy

Location

A.O.U. Maggiore della Carità

Novara, Piedmont, 28100, Italy

Location

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

Sassari, Sardinia, 07100, Italy

Location

Policlinico Vittorio Emanuele

Catania, Sicily, 95123, Italy

Location

Ospedale Versilia

Lido di Camaiore, Tuscany, 55043, Italy

Location

Ospedale Civile - Livorno

Livorno, Tuscany, 57124, Italy

Location

National Hospital Organization Shikoku Cancer Center

Ehime, 791-0280, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, 810-8563, Japan

Location

NHO Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Kurume University Hospital

Fukuoka, 830-0011, Japan

Location

Kanagawa Cardiovascular and Respiratory Center

Kanagawa, 236-0051, Japan

Location

Kitasato University Hospital

Kanagawa, 252-0375, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Miyagi Cancer Center

Miyagi, 981-1293, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Osaka City University Hospital

Osaka, 545-8586, Japan

Location

National Hospital Organization Osaka Toneyama Medical Center

Osaka, 560-8552, Japan

Location

Toranomon Hospital

Tokyo, 105-8470, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Tokyo, 162-0052, Japan

Location

Kyorin University Hospital

Tokyo, 181-8611, Japan

Location

Wakayama Medical University Hospital

Wakayama, 641-8510, Japan

Location

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

Riga East Clinical University Hospital Latvian Oncology Centre

Riga, LV-1079, Latvia

Location

National Cancer Institute

Vilnius, 08660, Lithuania

Location

Centro Universitario Contra El Cancer

Monterrey, 64020, Mexico

Location

Cancerologia de Queretaro

Querétaro, 76090, Mexico

Location

Centro Hemato Oncologico Privado; Oncologia

Toluca, 50080, Mexico

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Amsterdam UMC Location VUMC

Amsterdam, 1081 HV, Netherlands

Location

Amphia Ziekenhuis; Afdeling Longziekten

Breda, 4818 CK, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, 6716 RP, Netherlands

Location

Tergooiziekenhuizen

Hilversum, 1201 DA, Netherlands

Location

Spaarne Gasthuis; Spaarne Ziekenhuis

Hoofddorp, 2134 TM, Netherlands

Location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

St. Antonius Ziekenhuis; R&D Long

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus MC; Afdeling Longziekten

Rotterdam, 3015 GD, Netherlands

Location

Maasstad ziekenhuis

Rotterdam, 3079 DZ, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Gelre Ziekenhuizen, Zutphen

Zutphen, 7207 AE, Netherlands

Location

Centro Medico Monte Carmelo

Arequipa, 04001, Peru

Location

Centro Especializado de Enfermedades Neoplásicas

Arequipa, Peru

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, Lima 34, Peru

Location

Centro Hospitalar E Universitário de Coimbra EPE

Coimbra, 3000-602, Portugal

Location

Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE

Lisbon, 1099-023, Portugal

Location

Hospital Pulido Valente; Servico de Pneumologia

Lisbon, 1796-001, Portugal

Location

Centro Hospitalar do Porto - Hospital de Santo António

Porto, 4099-001, Portugal

Location

Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

Porto, 4200-072, Portugal

Location

Hospital de Sao Joao; Servico de Pneumologia

Porto, 4200, Portugal

Location

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, 143423, Russia

Location

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

Moscow, 115478, Russia

Location

Clinical Oncology Dispensary

Omsk, 644013, Russia

Location

Evromedservis LCC

Pushkin, 196603, Russia

Location

City Clinical Oncology Dispensary

Saint Petersburg, 197022, Russia

Location

National Cancer Centre; Medical Oncology

Singapore, 169610, Singapore

Location

Univerzitna nemocnica Bratislava

Bratislava, 813 69, Slovakia

Location

Narodny onkologicky ustav

Bratislava, 833 10, Slovakia

Location

POKO Poprad s.r.o.

Poprad, 058 01, Slovakia

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

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

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, 8208, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, LAS Palmas, 35016, Spain

Location

Complejo Hospitalario U. de Ourense

Ourense, Orense, 32005, Spain

Location

Hospital Lluis Alcanyis De Xativa

Xàtiva, Valencia, 46800, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Lucus Augusti; Servicio de Oncologia

Lugo, 27003, Spain

Location

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, 28007, Spain

Location

Hospital Universitario La Paz

Madrid, 280146, Spain

Location

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

Location

Hospital Clinico San Carlos; Servicio de Oncologia

Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jimenez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario HM Sanchinarro-CIOCC

Madrid, 28050, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Kantonsspital Baselland

Bruderholz, 4101, Switzerland

Location

Luzerner Kantonsspital Sursee

Lucerne, 6000, Switzerland

Location

Kantonsspital St. Gallen; Onkologie/Hämatologie

Sankt Gallen, 9007, Switzerland

Location

Changhua Christian Hospital; Hematology-Oncology

Changhua, 500, Taiwan

Location

Kaohsiung Medical University Hospital; Department of Urology

Kaohsiung City, 807, Taiwan

Location

Chi Mei Medical Center Liou Ying Campus

Liuying Township, 736, Taiwan

Location

Chang Gung Memorial Hospital Chiayi

Putzu, 613, Taiwan

Location

National Cheng Kung Univ Hosp

Tainan, 00704, Taiwan

Location

National Taiwan Uni Hospital

Taipei, 10041, Taiwan

Location

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

Chang Gung Medical Foundation Linkou Branch

Taoyuan, 333, Taiwan

Location

Taichung Veterans General Hospital

Xitun Dist., 40705, Taiwan

Location

ME Bukovinian Clinical Oncology Center

Chernivtsi, Chernihiv Governorate, 58013, Ukraine

Location

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

Dnipropetrovsk, Katerynoslav Governorate, 49102, Ukraine

Location

Uzhgorod Central City Clinical Hospital

Uzhhorod, Katerynoslav Governorate, 88000, Ukraine

Location

MNPE Zaporizhzhia Regional Antitumor Center ZRC

Zaporizhzhia, Katerynoslav Governorate, 69040, Ukraine

Location

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

Kharkiv, Kharkiv Governorate, 61070, Ukraine

Location

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

Uzhhorod, Kherson Governorate, 88014, Ukraine

Location

Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2

Ivano-Frankivsk, KIEV Governorate, 76018, Ukraine

Location

Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

Vinnytsia, KIEV Governorate, 21029, Ukraine

Location

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

Kharkiv, 61024, Ukraine

Location

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

Kryvyi Rih, 50048, Ukraine

Location

Kyiv City Clinical Oncological Center

Kyiv, 03115, Ukraine

Location

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

Poltava, 36011, Ukraine

Location

Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

Sumy, 40005, Ukraine

Location

Related Publications (9)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumabBevacizumabCarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 19, 2015

Study Start

March 31, 2015

Primary Completion

September 13, 2019

Study Completion

December 7, 2020

Last Updated

September 23, 2021

Results First Posted

October 27, 2020

Record last verified: 2021-08

Locations