A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]

NCT ID: NCT02367794

Last Updated: 2022-03-21

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

1021 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-11

Study Completion Date

2021-02-17

Brief Summary

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This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

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Detailed Description

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Conditions

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Squamous Non-Small Cell Lung Cancer

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

The induction phase of the study will consist of four or six cycles; atezolizumab, paclitaxel, and carboplatin will be administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.

Group Type EXPERIMENTAL

Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody

Intervention Type DRUG

Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.

Carboplatin

Intervention Type DRUG

Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.

Paclitaxel

Intervention Type DRUG

Paclitaxel 200 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m\^2 IV.

Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin

The induction phase of the study will consist of four or six cycles; atezolizumab and carboplatin will be administered on Day 1 of each 21-day cycle. Nab-Paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.

Group Type EXPERIMENTAL

Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody

Intervention Type DRUG

Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.

Carboplatin

Intervention Type DRUG

Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.

Nab-Paclitaxel

Intervention Type DRUG

Nab-paclitaxel 100 milligrams per meter squared (mg/m\^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.

Arm C: Nab-Paclitaxel + Carboplatin

The induction phase of the study will consist of four or six cycles; carboplatin will be administered on Day 1 of each 21-day cycle, nab-paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: nab-paclitaxel, then carboplatin. Participants who experience disease progression at any time during the induction phase will discontinue all study treatment. In the maintenance phase, participants will receive best supportive care.

Group Type ACTIVE_COMPARATOR

Carboplatin

Intervention Type DRUG

Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.

Nab-Paclitaxel

Intervention Type DRUG

Nab-paclitaxel 100 milligrams per meter squared (mg/m\^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.

Interventions

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Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody

Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.

Intervention Type DRUG

Carboplatin

Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.

Intervention Type DRUG

Nab-Paclitaxel

Nab-paclitaxel 100 milligrams per meter squared (mg/m\^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.

Intervention Type DRUG

Paclitaxel

Paclitaxel 200 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m\^2 IV.

Intervention Type DRUG

Other Intervention Names

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Tecentriq

Eligibility Criteria

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Inclusion Criteria

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
* Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and end organ function

Exclusion Criteria

* Active or untreated central nervous system (CNS) metastasis
* 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 (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Positive test for Human Immunodeficiency Virus (HIV)
* Active hepatitis B or hepatitis C
* Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
* Severe infection within 4 weeks prior to randomization
* Significant history of cardiovascular disease
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

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status

Southern CA Permanente Med Grp

Bellflower, California, United States

Site Status

Kaiser Permanente Oakland Medical Center

Oakland, California, United States

Site Status

Kaiser Permanente - Sacramento Medical Center and Medical Offices

Sacramento, California, United States

Site Status

Kaiser Permanente - San Leandro Medical Center

San Leandro, California, United States

Site Status

Kaiser Permanente - Santa Clara

Santa Clara, California, United States

Site Status

Kaiser Permanente; Oncology Clinical Trials

Vallejo, California, United States

Site Status

Kaiser Permanente - Walnut Creek

Walnut Creek, California, United States

Site Status

Rocky Mountain Cancer Center

Denver, Colorado, United States

Site Status

Danbury Hospital

Danbury, Connecticut, United States

Site Status

Holy Cross Hospital Inc

Fort Lauderdale, Florida, United States

Site Status

SCRI Florida Cancer Specialists South

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialists

Palm Beach Gardens, Florida, United States

Site Status

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Site Status

Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

St. Petersburg, Florida, United States

Site Status

University Cancer & Blood Center, LLC; Research

Athens, Georgia, United States

Site Status

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Carrollton, Georgia, United States

Site Status

Central Georgia Cancer Care PC

Macon, Georgia, United States

Site Status

Southeastern Regional Medical Center, Inc.

Newnan, Georgia, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Joliet Oncology-Hematology; Associates, Ltd.

Joliet, Illinois, United States

Site Status

Quincy Medical Group

Quincy, Illinois, United States

Site Status

Fort Wayne Med Oncology & Hematology Inc

Fort Wayne, Indiana, United States

Site Status

Hematology-Oncology; Associates of the Quad Cities

Bettendorf, Iowa, United States

Site Status

Siouxland Hematology/Oncology

Sioux City, Iowa, United States

Site Status

Lahey Clinic Med Ctr

Lexington, Kentucky, United States

Site Status

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

New England Cancer Specialists

Scarborough, Maine, United States

Site Status

Southcoast Health System; Southcoast Centers For Cancer Care

Fairhaven, Massachusetts, United States

Site Status

St. Joseph Mercy Health System

Ann Arbor, Michigan, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

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St. Luke's Regional Cancer Center

Duluth, Minnesota, United States

Site Status

Hematology and Oncology Associates at Bridgepoint

Tupelo, Mississippi, United States

Site Status

Billings Clinic

Billings, Montana, United States

Site Status

Valley Hospital; Oncology Research

Paramus, New Jersey, United States

Site Status

Regional Cancer Care Associates LLC

Sewell, New Jersey, United States

Site Status

Clinical Research Alliance

Westbury, New York, United States

Site Status

W.G. Bill Hefner VA Medical Center

Salisbury, North Carolina, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

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Mark H. Zangmeister Center

Columbus, Ohio, United States

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Oncology Hematology Care, Inc.

Hamilton, Ohio, United States

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Oregon Health & Science Uni

Portland, Oregon, United States

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St. Luke's Cancer Care Associates

Bethlehem, Pennsylvania, United States

Site Status

Maryland Oncology Hematology (Lanham) - USOR

Gettysburg, 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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SCRI Tennessee Oncology Chattanooga

Chattanooga, Tennessee, United States

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Tennessee Cancer Specialists

Knoxville, Tennessee, United States

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SCRI The Center For Cancer and Blood Disorders

Denton, Texas, United States

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Longview Cancer Center

Longview, 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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Blue Ridge Cancer Care

Roanoke, Virginia, United States

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Providence Regional Cancer Partnership

Everett, Washington, United States

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Medical Oncology Associates

Spokane, Washington, United States

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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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Clínica Pergamino

Pergamino, , 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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Calvary Mater Newcastle; Medical Oncology

Waratah, New South Wales, Australia

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Prince Charles Hospital

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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Austin Health

Heidelberg, Victoria, Australia

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Cabrini Hospital Malvern

Malvern, 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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Cliniques Universitaires St-Luc

Brussels, , Belgium

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CHU Sart-Tilman

Liège, , Belgium

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Clinique Ste-Elisabeth

Namur, , Belgium

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Werken Glorieux VZW

Ronse, , Belgium

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GasthuisZusters Antwerpen

Wilrijk, , Belgium

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Cenantron - Centro Avancado de Tratamento Oncologico

Belo Horizonte, 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 Bruno Born

Lajeado, Rio Grande do Sul, Brazil

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Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

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Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, Brazil

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*X*Fundação Pio XII Hospital de Câncer de Barretos

Barretos, 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 Do Cancer A C Camargo

São Paulo, São Paulo, Brazil

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Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

Plovdiv, , Bulgaria

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Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, , Bulgaria

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Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

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William Osler Health Centre

Etobicoke, Ontario, Canada

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Lakeridge Health Center

Oshawa, Ontario, Canada

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Cite de La Sante de Laval; Hemato-Oncologie

Laval, Quebec, Canada

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Hôpital du Sacré-Coeur de Montreal

Montreal, Quebec, Canada

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St. Jerome Medical Research

Saint-Jérôme, Quebec, Canada

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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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CHU de Grenoble

Grenoble, , France

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Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd

Le Mans, , France

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Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

Lyon, , France

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Clinique Clémentville

Montpellier, , France

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Hopital de La Source

Orléans, , France

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Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

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Hopital de Pontchaillou; Service de Pneumologie

Rennes, , France

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Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

Saint-Pierre, , France

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CH de Saint Quentin

Saint-Quentin, , France

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Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques

Toulon, , France

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Charite - Universitätsmedizin Berlin

Berlin, , Germany

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

Bielefeld, , Germany

Site Status

Augusta Kranken-Anstalt gGmbH

Bochum, , Germany

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Kliniken der Stadt Koln gGmbH

Cologne, , Germany

Site Status

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, , Germany

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St. Elisabethen Krankenhaus

Frankfurt am Main, , Germany

Site Status

Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

Gerlingen, , Germany

Site Status

LungenClinic Großhansdorf GmbH

Großhansdorf, , Germany

Site Status

Krankenhaus Martha-Maria; Halle-Dolau gGmbH

Halle, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

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Asklepios Klinik Harburg

Hamburg, , Germany

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Lungenklinik Hemer

Hemer, , Germany

Site Status

Universität Des Saarlandes; Klinik für Innere Medizin V

Homburg, , Germany

Site Status

Fachklinik für Lungenerkrankungen

Immenhausen, , Germany

Site Status

Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin

Minden, , Germany

Site Status

Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie

München, , Germany

Site Status

Krankenhaus Barmherzige Bruder Regensburg

Regensburg, , Germany

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Klinikum der Universität Regensburg

Regensburg, , Germany

Site Status

Stiftung Mathias-Spital Rheine

Rheine, , Germany

Site Status

Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

Villingen-Schwenningen, , Germany

Site Status

Soroka Medical Center

Beersheba, , Israel

Site Status

Hadassah University Hospital - Ein Kerem

Jerusalem, , Israel

Site Status

Meir Medical Center; Oncology

Kfar Saba, , Israel

Site Status

Rabin Medical Center

Petach Tiqwa, , Israel

Site Status

Chaim Sheba Medical Center; Oncology Dept

Ramat Gan, , Israel

Site Status

Rambam Health Corporation; Oncology Institute

Rambam, , Israel

Site Status

Tel Aviv Sourasky Medical Ctr; Oncology

Tel Aviv, , Israel

Site Status

IRCCS Giovanni Paolo II Istituto Oncologico

Bari, Apulia, Italy

Site Status

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

Avellino, Campania, Italy

Site Status

AORN A Cardarelli

Napoli, Campania, Italy

Site Status

Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata

Napoli, Campania, Italy

Site Status

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

Napoli, Campania, Italy

Site Status

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, Italy

Site Status

ASL 3 Genovese; DSM

Genoa, Liguria, Italy

Site Status

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy

Site Status

Policlinico Vittorio Emanuele

Catania, Sicily, Italy

Site Status

Ospedale Civile - Livorno

Livorno, Tuscany, Italy

Site Status

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Site Status

Ospedale Silvestrini

Perugia, Umbria, Italy

Site Status

Aichi Cancer Center Hospital; Respiratory Medicine

Aichi, , Japan

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Nagoya University Hospital; Respiratory Medicine

Aichi, , Japan

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National Cancer Center Hospital East; Thoracic Oncology

Chiba, , Japan

Site Status

National Hospital Organization Shikoku Cancer Center; Internal Medicine

Ehime, , Japan

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National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine

Fukuoka, , Japan

Site Status

Kyushu University Hospital; Respiratory

Fukuoka, , Japan

Site Status

Kobe City Medical Center General Hospital; Respiratory Medicine

Hyōgo, , Japan

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National Hospital Organization Himeji Medical Center

Hyōgo, , Japan

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Hyogo Cancer Center; Thoracic Oncology

Hyōgo, , Japan

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Ibaraki Prefectural Central Hospital; Division of respiratory

Ibaraki, , Japan

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Kanagawa Cancer Center;Thoracic Oncology

Kanagawa, , Japan

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Kyoto University Hospital, Respiratory Medicine

Kyoto, , Japan

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Sendai Kousei Hospital; Pulmonary Medicine

Miyagi, , Japan

Site Status

Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease

Niigata, , Japan

Site Status

Okayama University Hospital; Respiratory and Allergy Medicine

Okayama, , Japan

Site Status

Osaka International Cancer Institute; Thoracic Oncology

Osaka, , Japan

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Osaka City Uni Hospital; Respiratory Medicine

Osaka, , Japan

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Kansai Medical university Hospital; Thoracic Oncology

Osaka, , Japan

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Osaka Habikino Medical Center

Osaka, , Japan

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National Hospital Organization Kinki-Chuo Chest Medical Center

Sakaishi, , Japan

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Saitama Cancer Center; Thoracic Oncology

Satima, , Japan

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Shizuoka Cancer Center; Thoracic Oncology

Shizuoka, , Japan

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National Cancer Center Hospital; Thoracic Medical Oncology

Tokyo, , Japan

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Tokyo Medical University Hospital; Dept of Surgery

Tokyo, , 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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Cancerología

Querétaro, , Mexico

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VU Medisch Centrum; VU University Medical Center

Amsterdam, , Netherlands

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Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

Amsterdam, , Netherlands

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Ziekenhuis Gelderse Vallei

Ede, , Netherlands

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Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose

Eindhoven, , Netherlands

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St. Antonius Ziekenhuis; R&D Long

Nieuwegein, , Netherlands

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Centro Medico Monte Carmelo

Arequipa, , Peru

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Hospital Nacional Guillermo Almenara Irigoyen ESSALUD

Lima, , Peru

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Instituto Regional de Enfermedades Neoplásicas Del Norte

Trujillo, , Peru

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IPO de Lisboa; Servico de Pneumologia

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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City Clinical Oncology Dispensary

Saint Petersburg, , Russia

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Volgograd Regional Clinical Oncology Dispensary

Volgograd, , Russia

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National University Hospital

Singapore, , Singapore

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National Cancer Centre

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

Site Status

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, Spain

Site Status

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, Spain

Site Status

Complejo Hospitalario Universitario A Coruña

A Coruña, LA Coruña, Spain

Site Status

Complejo Hospitalario Universitario Insular-Materno Infantil

Las Palmas de Gran Canaria, LAS Palmas, Spain

Site Status

Hospital Nuestra Senora de Valme

Seville, Sevilla, Spain

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Hospital Universitario de Canarias

S. Cristobal de La Laguna, Tenerife, 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 de la Santa Creu i Sant Pau; Servicio de Oncologia

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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Fundación Jimenez Díaz

Madrid, , Spain

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Hospital Clinico San Carlos; Servicio de Oncologia

Madrid, , Spain

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Hospital Universitario 12 de Octubre

Madrid, , Spain

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HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

Madrid, , Spain

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Hospital Clinico Universitario de Valencia

Valencia, , Spain

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Hospital General Universitario de Valencia

Valencia, , Spain

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Hospital Universitario Miguel Servet

Zaragoza, , Spain

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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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China Medical University Hospital

Taichung, , Taiwan

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National Taiwan Uni Hospital

Taipei, , Taiwan

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Mackay Memorial Hospital

Taipei, , Taiwan

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

Dnipropetrovsk, Katerynoslav Governorate, Ukraine

Site Status

Uzhgorod Central City Clinical Hospital

Uzhhorod, Katerynoslav Governorate, Ukraine

Site Status

MNPE Zaporizhzhia Regional Antitumor Center ZRC

Zaporizhzhia, Katerynoslav Governorate, Ukraine

Site Status

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

Kharkiv, Kharkiv Governorate, Ukraine

Site Status

Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

Vinnytsia, KIEV Governorate, Ukraine

Site Status

MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy

Lviv, Volhynian Governorate, Ukraine

Site Status

Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1

Chernivtsi, , 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

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 Israel Italy Japan Latvia Lithuania Mexico Netherlands Peru Portugal Russia Singapore Slovakia Spain Taiwan Ukraine

References

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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)

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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2014-003208-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO29437

Identifier Type: -

Identifier Source: org_study_id

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