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)

NCT ID: NCT02366143

Last Updated: 2021-09-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-12-07

Brief Summary

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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).

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Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Carboplatin

Intervention Type DRUG

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.

Paclitaxel

Intervention Type DRUG

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 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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Bevacizumab

Intervention Type DRUG

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.

Carboplatin

Intervention Type DRUG

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.

Paclitaxel

Intervention Type DRUG

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 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.

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

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.

Carboplatin

Intervention Type DRUG

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.

Paclitaxel

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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MPDL3280A RO5541267 Tecentriq

Eligibility Criteria

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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


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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Site Status

Arizona Oncology Associates

Flagstaff, Arizona, United States

Site Status

Southern CA Permanente Med Grp

Bellflower, California, United States

Site Status

Marin Cancer Care Inc

Greenbrae, California, United States

Site Status

Scripps Health

La Jolla, California, United States

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Chao Family Comprehensive Cancer Center UCI

Orange, California, United States

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Rocky Mountain Cancer Center

Denver, Colorado, United States

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Kaiser Permanente

Lonetree, Colorado, United States

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Danbury Hospital

Danbury, Connecticut, United States

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Yale Cancer Center

New Haven, Connecticut, United States

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Holy Cross Hospital Inc

Fort Lauderdale, Florida, United States

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Cancer Specialists of North Florida - Baptist South

Jacksonville, Florida, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

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Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Site Status

Piedmont Cancer Institute, PC

Atlanta, Georgia, United States

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Rush University Medical Center

Chicago, Illinois, United States

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Univ of Chicago

Chicago, Illinois, United States

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Ingalls Memorial Hospital

Harvey, Illinois, United States

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Oncology Specialists, S.C.

Park Ridge, Illinois, United States

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Hematology-Oncology; Associates of the Quad Cities

Bettendorf, Iowa, United States

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Norton Cancer Institute

Louisville, Kentucky, United States

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New England Cancer Specialists

Scarborough, Maine, United States

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Mercy Medical Center

Baltimore, Maryland, United States

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Regional Cancer Care Associates

Bethesda, Maryland, United States

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Maryland Oncology Hematology, P.A.

Columbia, Maryland, United States

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St. Joseph Mercy Health System

Ann Arbor, Michigan, United States

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St. Luke's Regional Cancer Center

Duluth, Minnesota, United States

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Park Nicolett - Frauenshuh Cancer Center

Saint Louis Park, Minnesota, United States

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St. Luke's Cancer Institute

Kansas City, Missouri, United States

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Missouri Baptist Medical Center

St Louis, Missouri, United States

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Billings Clinic

Billings, Montana, United States

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Montana Cancer Specialists

Missoula, Montana, United States

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Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

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Summit Medical Group

Berkeley Heights, New Jersey, United States

Site Status

Valley Hospital; Oncology Research

Paramus, New Jersey, United States

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Regional Cancer Care Associates LLC

Sewell, New Jersey, United States

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Maimonides Medical Center

Brooklyn, New York, United States

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Montefiore Medical Center

The Bronx, New York, United States

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First Health of the Carolinas

Pinehurst, North Carolina, United States

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University of Cincinnati

Cincinnati, Ohio, United States

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Mercy St Anne Hospital

Toledo, Ohio, United States

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Bend Memorial Clinic

Bend, Oregon, United States

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

Bend, Oregon, United States

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Willamette Valley Cancer Insitute and Research Center

Springfield, Oregon, United States

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St. Luke's Cancer Care Associates

Bethlehem, Pennsylvania, United States

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Allegheny Cancer Center

Pittsburgh, Pennsylvania, United States

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Univ of Pittsburgh Medical Ctr

Pittsburgh, Pennsylvania, United States

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West Clinic

Germantown, Tennessee, United States

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Tennessee Cancer Specialists

Knoxville, Tennessee, United States

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Houston Methodist Cancer Center

Houston, Texas, United States

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Longview Cancer Center

Longview, Texas, United States

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University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

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Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

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Virginia Oncology Associates

Norfolk, Virginia, United States

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Virginia Cancer Institute

Richmond, Virginia, United States

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Blue Ridge Cancer Care

Roanoke, Virginia, United States

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MultiCare Regional Cancer Center - Auburn

Auburn, Washington, United States

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Providence Regional Cancer Partnership

Everett, Washington, United States

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Virginia Mason Medical Center

Seattle, Washington, United States

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Medical Oncology Associates

Spokane, Washington, United States

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West Virginia University; Mary Babb Randolph Can Ctr

Morgantown, West Virginia, United States

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Centro Medico Austral

Buenos Aires, , Argentina

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Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, , Argentina

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Sanatorio Allende

Córdoba, , Argentina

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Centro Oncologico Riojano Integral (CORI)

La Rioja, , Argentina

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Hospital Provincial del Centenario

Rosario, , Argentina

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Fundacion Koriza

Santa Rosa, , Argentina

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

Viedma, , Argentina

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Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

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Concord Repatriation General Hospital

Concord, New South Wales, Australia

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Nepean Cancer Care Centre

Sydney, New South Wales, Australia

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Prince Charles Hospital; Department of Medical Oncology

Chermside, Queensland, Australia

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Townsville Hospital

Townsville, Queensland, Australia

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Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

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Royal Adelaide Hospital

Adelaide, South Australia, Australia

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Adelaide Cancer Centre

Kurralta Park, South Australia, Australia

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Royal Hobart Hospital

Hobart, Tasmania, Australia

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Launceston General Hospital

Launceston, Tasmania, Australia

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Frankston Hospital

Frankston, Victoria, Australia

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Austin Health

Heidelberg, Victoria, Australia

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Cabrini Hospital Malvern

Malvern, Victoria, Australia

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The Alfred Hospital

Prahan, Victoria, Australia

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Sunshine Hospital

St Albans, Victoria, Australia

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Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

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Paracelsus Medizinische Privatuniversität

Salzburg, , Austria

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Klinikum Wels-Grieskirchen

Wels, , Austria

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CHU de Liège

Liège, , Belgium

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Clinique Ste-Elisabeth

Namur, , Belgium

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CETUS Hospital Dia Oncologia

Uberaba, Minas Gerais, Brazil

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Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica

Londrina, Paraná, Brazil

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Liga Norte Riograndense Contra O Câncer

Natal, Rio Grande do Norte, Brazil

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IPCEM; Instituto de Pesquisa de Estudos Multicêntricos

Caxias do Sul, Rio Grande do Sul, Brazil

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Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, Brazil

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Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

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Instituto Ribeirãopretano de Combate Ao Câncer; Centro Especializado De Oncologia

Ribeirão Preto, São Paulo, Brazil

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Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

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Hospital A. C. Camargo; Oncologia

São Paulo, São Paulo, Brazil

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Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

Plovdiv, , Bulgaria

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MHAT Serdika, EOOD

Sofia, , Bulgaria

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Lakeridge Health Center

Oshawa, Ontario, Canada

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Clinica Santa Maria

Santiago, , Chile

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Health & Care SPA

Santiago, , Chile

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Sociedad de Investigaciones Medicas Ltda (SIM)

Temuco, , Chile

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

Bordeaux, , France

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CHU de Grenoble

Grenoble, , France

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Centre Jean Bernard Clinique Victor Hugo

Le Mans, , France

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Hôpital Saint Joseph

Marseille, , France

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Hopital Nord AP-HM

Marseille, , France

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Hôpital Européen Georges Pompidou

Paris, , France

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CHU de Bordeaux

Pessac, , France

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Service de Pneumologie Centre Hospitalier Régional La Réunion Site Felix Guyon

Saint-Denis, , France

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CH de Saint Quentin

Saint-Quentin, , France

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Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

Toulon, , France

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

Toulon, , France

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Hôpital Larrey;Université Paul Sabatier

Toulouse, , France

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Zentralklinikum Augsburg

Augsburg, , Germany

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Helios Klinikum Emil von Behring GmbH

Berlin, , Germany

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

Bielefeld, , Germany

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Augusta Kranken-Anstalt gGmbH

Bochum, , Germany

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Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz

Cologne, , Germany

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Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, , Germany

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St. Elisabethen Krankenhaus

Frankfurt am Main, , Germany

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LungenClinic Großhansdorf GmbH

Großhansdorf, , Germany

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Krankenhaus Martha-Maria; Halle-Dolau gGmbH

Halle, , Germany

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Asklepios Klinik Harburg

Hamburg, , Germany

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Lungenklinik Hemer

Hemer, , Germany

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Universität Des Saarlandes; Klinik für Innere Medizin V

Homburg, , Germany

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Klinik Loewenstein gGmbH; Onk & Pal

Löwenstein, , Germany

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Klinikum Bogenhausen

München, , Germany

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Krankenhaus Barmherzige Bruder Regensburg

Regensburg, , Germany

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Klinikum der Universität Regensburg

Regensburg, , Germany

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Stiftung Mathias-Spital Rheine

Rheine, , Germany

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AORN A Cardarelli

Napoli, Campania, Italy

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Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

Rome, Lazio, Italy

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Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, Italy

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Università Cattolica Del S Cuore

Rome, Lazio, Italy

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Istituto Nazionale per la Ricerca sul Cancro di Genova

Genoa, Liguria, Italy

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ASL 3 Genovese; DSM

Genoa, Liguria, Italy

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A.O.U. Maggiore della Carità

Novara, Piedmont, Italy

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

Sassari, Sardinia, Italy

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Policlinico Vittorio Emanuele

Catania, Sicily, Italy

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Ospedale Versilia

Lido di Camaiore, Tuscany, Italy

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Ospedale Civile - Livorno

Livorno, Tuscany, Italy

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National Hospital Organization Shikoku Cancer Center

Ehime, , Japan

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National Hospital Organization Kyushu Medical Center

Fukuoka, , Japan

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NHO Kyushu Cancer Center

Fukuoka, , Japan

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Kurume University Hospital

Fukuoka, , Japan

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Kanagawa Cardiovascular and Respiratory Center

Kanagawa, , Japan

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Kitasato University Hospital

Kanagawa, , Japan

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Kyoto University Hospital

Kyoto, , Japan

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Miyagi Cancer Center

Miyagi, , Japan

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Niigata Cancer Center Hospital

Niigata, , Japan

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Osaka City University Hospital

Osaka, , Japan

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National Hospital Organization Osaka Toneyama Medical Center

Osaka, , Japan

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Toranomon Hospital

Tokyo, , Japan

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Center Hospital of the National Center for Global Health and Medicine

Tokyo, , Japan

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Kyorin University Hospital

Tokyo, , Japan

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Wakayama Medical University Hospital

Wakayama, , Japan

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Pauls Stradins Clinical University Hospital

Riga, , Latvia

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Riga East Clinical University Hospital Latvian Oncology Centre

Riga, , Latvia

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National Cancer Institute

Vilnius, , Lithuania

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Centro Universitario Contra El Cancer

Monterrey, , Mexico

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Cancerologia de Queretaro

Querétaro, , Mexico

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Centro Hemato Oncologico Privado; Oncologia

Toluca, , Mexico

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Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

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Amsterdam UMC Location VUMC

Amsterdam, , Netherlands

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Amphia Ziekenhuis; Afdeling Longziekten

Breda, , Netherlands

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Ziekenhuis Gelderse Vallei

Ede, , Netherlands

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Tergooiziekenhuizen

Hilversum, , Netherlands

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Spaarne Gasthuis; Spaarne Ziekenhuis

Hoofddorp, , Netherlands

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Maastricht University Medical Center

Maastricht, , Netherlands

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St. Antonius Ziekenhuis; R&D Long

Nieuwegein, , Netherlands

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Erasmus MC; Afdeling Longziekten

Rotterdam, , Netherlands

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Maasstad ziekenhuis

Rotterdam, , Netherlands

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Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

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Gelre Ziekenhuizen, Zutphen

Zutphen, , Netherlands

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Centro Medico Monte Carmelo

Arequipa, , Peru

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Centro Especializado de Enfermedades Neoplásicas

Arequipa, , Peru

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Instituto Nacional de Enfermedades Neoplasicas

Lima, , Peru

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Centro Hospitalar E Universitário de Coimbra EPE

Coimbra, , Portugal

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Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE

Lisbon, , Portugal

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Hospital Pulido Valente; Servico de Pneumologia

Lisbon, , Portugal

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Centro Hospitalar do Porto - Hospital de Santo António

Porto, , Portugal

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Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

Porto, , Portugal

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Hospital de Sao Joao; Servico de Pneumologia

Porto, , Portugal

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Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, Russia

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

Moscow, , Russia

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Clinical Oncology Dispensary

Omsk, , Russia

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Evromedservis LCC

Pushkin, , Russia

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City Clinical Oncology Dispensary

Saint Petersburg, , Russia

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National Cancer Centre; Medical Oncology

Singapore, , Singapore

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Univerzitna nemocnica Bratislava

Bratislava, , Slovakia

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Narodny onkologicky ustav

Bratislava, , Slovakia

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POKO Poprad s.r.o.

Poprad, , Slovakia

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Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

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

L'Hospitalet de Llobregat, Barcelona, Spain

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Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, Spain

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Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

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Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, LAS Palmas, Spain

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Complejo Hospitalario U. de Ourense

Ourense, Orense, Spain

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Hospital Lluis Alcanyis De Xativa

Xàtiva, Valencia, Spain

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Hospital del Mar

Barcelona, , Spain

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Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, , Spain

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Hospital Clinic de Barcelona

Barcelona, , Spain

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Hospital Universitario Reina Sofia

Córdoba, , Spain

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Hospital Lucus Augusti; Servicio de Oncologia

Lugo, , Spain

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Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, , Spain

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Hospital Universitario La Paz

Madrid, , Spain

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Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, , Spain

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Hospital Clinico San Carlos; Servicio de Oncologia

Madrid, , Spain

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Hospital Universitario Fundación Jimenez Díaz

Madrid, , Spain

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Hospital Universitario 12 de Octubre

Madrid, , Spain

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Hospital Universitario HM Sanchinarro-CIOCC

Madrid, , Spain

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Hospital Clinico Universitario de Valencia

Valencia, , Spain

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Kantonsspital Baselland

Bruderholz, , Switzerland

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Luzerner Kantonsspital Sursee

Lucerne, , Switzerland

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Kantonsspital St. Gallen; Onkologie/Hämatologie

Sankt Gallen, , Switzerland

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Changhua Christian Hospital; Hematology-Oncology

Changhua, , Taiwan

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Kaohsiung Medical University Hospital; Department of Urology

Kaohsiung City, , Taiwan

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Chi Mei Medical Center Liou Ying Campus

Liuying Township, , Taiwan

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Chang Gung Memorial Hospital Chiayi

Putzu, , Taiwan

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National Cheng Kung Univ Hosp

Tainan City, , Taiwan

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National Taiwan Uni Hospital

Taipei, , Taiwan

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Cheng Hsin General Hospital

Taipei, , Taiwan

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Tri-Service General Hospital

Taipei, , Taiwan

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Chang Gung Medical Foundation Linkou Branch

Taoyuan, , Taiwan

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Taichung Veterans General Hospital

Xitun Dist., , Taiwan

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ME Bukovinian Clinical Oncology Center

Chernivtsi, Chernihiv Governorate, Ukraine

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

Dnipropetrovsk, Katerynoslav Governorate, Ukraine

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Uzhgorod Central City Clinical Hospital

Uzhhorod, Katerynoslav Governorate, Ukraine

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MNPE Zaporizhzhia Regional Antitumor Center ZRC

Zaporizhzhia, Katerynoslav Governorate, Ukraine

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

Kharkiv, Kharkiv Governorate, Ukraine

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

Uzhhorod, Kherson Governorate, Ukraine

Site Status

Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2

Ivano-Frankivsk, KIEV Governorate, Ukraine

Site Status

Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

Vinnytsia, KIEV Governorate, Ukraine

Site Status

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

Kharkiv, , Ukraine

Site Status

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

Kryvyi Rih, , Ukraine

Site Status

Kyiv City Clinical Oncological Center

Kyiv, , Ukraine

Site Status

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

Poltava, , Ukraine

Site Status

Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

Sumy, , Ukraine

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile France Germany Italy Japan Latvia Lithuania Mexico Netherlands Peru Portugal Russia Singapore Slovakia Spain Switzerland Taiwan Ukraine

References

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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.

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PMID: 40379995 (View on PubMed)

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.

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PMID: 37545290 (View on PubMed)

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.

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PMID: 36795388 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35511917 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34626838 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34311108 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32459597 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30922878 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29863955 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2014-003207-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO29436

Identifier Type: -

Identifier Source: org_study_id

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