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ACTIVE NOT RECRUITING
NCT02273375
PHASE3

Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC

Sponsor: Canadian Cancer Trials Group

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer.

Official title: A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1415

Start Date

2015-02-24

Completion Date

2026-01-31

Last Updated

2025-08-12

Healthy Volunteers

No

Interventions

DRUG

MEDI4736

DRUG

Placebo

Locations (271)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

USC Norris/Comprehensive Cancer Centre

Los Angeles, California, United States

National Jewish Health

Denver, Colorado, United States

University of Florida

Gainesville, Florida, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Duke University Medical Center

Durham, North Carolina, United States

Hematology and Oncology Associates of NEPA

Dunmore, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

The Reading Hospital Medical Center

West Reading, Pennsylvania, United States

Campbelltown Hospital

Campbelltown, New South Wales, Australia

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Coffs Habour Health Campus - NCCI

Coffs Harbour, New South Wales, Australia

Gosford Hospital

Gosford, New South Wales, Australia

Nepean Hospital

Kingswood, New South Wales, Australia

St. George Hospital, Cancer Care Centre

Kogarah, New South Wales, Australia

Liverpool Cancer Therapy Centre, Liverpool Hospital

Liverpool, New South Wales, Australia

Northern Cancer Institute St Leonards

St Leonards, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

The Prince Charles Hospital

Chermside, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Mater Medical Centre

Brisbane, South, QLD, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Frankston Hospital - Peninsula Oncology Centre

Frankston, Victoria, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Royal Melbourne Hospital Research Foundation

Parkville, Victoria, Australia

Epworth HealthCare - Richmond

Richmond, Victoria, Australia

Border Medical Oncology

Wodonga, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

St John of God Subiaco

Subiaco, Western Australia, Australia

Flinders Medical Center

Adelaide, Australia

Canberra Hospital

Garran, Australia

St. Vincent's Hospital

Victoria Park, Australia

Suporte Nutricional e Quimioterapia LTDA PRONUTRIR

Fortaleza, Ceará, Brazil

Hospital Evangelico de Cachoeiro de Itapemirim

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Cetus Hospital Dia Oncologia

Belo Horizonte, Minas Gerais, Brazil

Liga Norte Riograndense Contra o Cancer

Natal, Rio Grande do Norte, Brazil

Instituto Tacchini de Pesquisa em Saude

Bento Gonçalves, Rio Grande do Sul, Brazil

Centro de Oncologia e Radioterapia (COR) Mae de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Faculdade de Medicina do ABC

São Paulo, Santo Andre, Brazil

Fundacao Faculdade Regional de Medicina

São José do Rio Preto, São Paulo, Brazil

Instituto Nacional de Cancer (INCA)

Rio de Janeiro, Brazil

MHAT Serdika - Medical Oncology Clinic

Sofia, Bulgaria

MHAT Nadezhda Hospital

Sofia, Bulgaria

Medical Centre Synexus

Sofia, Bulgaria

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

BCCA - Abbotsford Centre

Abbotsford British Columbia, British Columbia, Canada

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, Canada

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

The Moncton Hospital

Moncton, New Brunswick, Canada

Regional Health Authority B, Zone 2

Saint John, New Brunswick, Canada

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Health Sciences North

Greater Sudbury, Ontario, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

London Regional Cancer Program

London, Ontario, Canada

Stronach Regional Health Centre at Southlake

Newmarket, Ontario, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Algoma District Cancer Program

Sault Ste. Marie, Ontario, Canada

Niagara Health System

St. Catharines, Ontario, Canada

Thunder Bay Regional Health Sciences Centre/Thunder

Thunder Bay, Ontario, Canada

Humber River Hospital

Toronto, Ontario, Canada

Odette Cancer Centre

Toronto, Ontario, Canada

Sinai Health System

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

PEI Cancer Treatment Centre

Charlottetown, Prince Edward Island, Canada

Lévis, Quebec, Canada

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

The Jewish General Hospital

Montreal, Quebec, Canada

The Research Institute of the McGill University

Montreal, Quebec, Canada

Centre Integre Universitaire De Sante Et De Services

Montreal, Quebec, Canada

University Institute of Cardiology and

Québec, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Province Cancer Hospital

Fuzhou, Fujian, China

Guangdong General Hospital

Guangzhou, Guangdong, China

The Second Affiliated Hosp of Shantou Medical Colleg

Shantou, Guangdong, China

The People Hospital of Guangxi Zhuang Autonomous Reg

Nanning, Guangxi, China

Henan province Cancer Hospital

Zhengzhou, Henan, China

The Second Xiangya Hospital of Central South Univer

Changsha, Hunan, China

The First People Hospital of Yueyang

Yueyang, Hunan, China

Nanjing General Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital Of Xuzhou Medical College

Xuzhou, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Northern Jiangsu People Hospital

Yangzhou, Jiangsu, China

Shandong Cancer Hospital

Jinan, Shandong, China

The Affiliated Hospital Of Qingdao University

Qingdao, Shandong, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Yunnan Provincial Cancer Hospital

Kunming, Yunnan, China

Sir run run shaw hospital School of Medicine

Hangzhou, Zhejiang, China

CRLCC - Paoli-Calmette

Marseille, BP, France

Hopital de la Croix-Rousse

Lyon, Cedex 04, France

Centre hospitalier universitaire de Montpellier

Montpellier, Cedex 05, France

AP-HP Hopital Tenon

Paris, Cedex 20, France

Hopital Albert Michallon

Grenoble, Cedex 9, France

CHRU de Tours - Hopital Bretonneau

Tours, Tours Cedex 9, France

CHU - Angers

Angers, France

Centre Hospitalier - Avignon

Avignon, France

Institut Sainte Catherine

Avignon, France

Bayonne - Centre Hospitalier

Bayonne, France

Hopital Jean Minjoz

Besançon, France

Hopital Avicenne

Bobigny, France

Polyclinique Bordeaux Nord

Bordeaux, France

Boulogne - Ambroise Pare

Boulogne, France

Caen - CHU

Caen, France

Centre Hospitalier de Chambery

Chambéry, France

Centre Hospitalier de Cholet

Cholet, France

HIA Percy

Clamart, France

Clermont-Ferrand - CHU

Clermont-Ferrand, France

Hopital Louis Pasteur

Colmar, France

Annemasse - Centre Hospitalier Alpes Leman

Contamine-sur-Arve, France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Centre Hospitalier Intercommunal de Creteil

Créteil, France

CHU Hopital du Bocage

Dijon, France

Centre Hospitalier Intercommunal - Elbeuf

Elbeuf, France

Centre Hospitalier departemental

La Roche-sur-Yon, France

Versailles - CH Andre Mignot

Le Chesnay, France

Centre Hospitalier du Mans

Le Mans, France

Lille - Hopital Calmette

Lille, France

Centre Hospitalier Lyon Sud

Lyon, France

Hopital Europeen

Marseille, France

Marseille - Hopital Nord

Marseille, France

Centre Hospitalier les Chanaux

Mâcon, France

CH de la Region d'Annecy

Metz-Tessy, France

Centre Hospitalier de Mulhouse

Mulhouse, France

Centre Antoine Lacassagne - Nice

Nice, France

Centre Hospitalier Regional Hopital de la Source

Orléans, France

Hopital Saint Louis

Paris, France

Fondation Hopital Saint Joseph

Paris, France

Paris - HEGP

Paris, France

Paris - Institut Curie

Paris, France

Hopital Bichat

Paris, France

Centre Hospitalier General de Pau

Pau, France

Centre Hospitalier de Perigueux

Périgueux, France

Centre Hospitalier Rene Dubos

Pontoise, France

CHU de Rouen

Rouen, France

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, France

Centre Hospitalier de Saint-Quentin

Saint-Quentin, France

Nouvel Hopital Civil Hopitaux

Strasbourg, France

Suresnes - Foch

Suresnes, France

Thonon-les-Bains - Hopital Georges Pianta

Thonon-les-Bains, France

CHITS Toulon Sainte Musse

Toulon, France

Hopital Larrey

Toulouse, France

Villefranche sur Saone - CH

Villefranche-sur-Saône, France

Semmelweis University Pulmonology Department

Budapest, Hungary

AOU Ospedali Riuniti Umberto I

Torrette, AN, Italy

Azienda Ospedaliera San Giuseppe Moscati

Avellino, AV, Italy

IRCCS Ospedale Oncologico Giovanni Paolo II

Bari, BA, Italy

Instituto Clinico Humanitas

Rozzano (MI), Lombardy, Italy

Ospedale S. Paolo - U.O. di Oncologia Medica

Milan, MI, Italy

Azienda Ospedaliera di Perugia Santa Maria

Perugia, PG, Italy

Centro di Riferimento Oncologico - CRO

Aviano, PN, Italy

Fondazione Salvatore Maugeri Oncologia Medica

Pavia, PV, Italy

OUC Oncologia Medica - Presidio Ospedaliero

Ravenna, RA, Italy

Oncologia Medica IRCCS Arcispedale Maria

Reggio Emilia, RE, Italy

Istituti Fisioterapici Ospitalieri IFO Istituto

Rome, RM, Italy

A.O. Busto Arsizio - P.O. Saronno

Saronno, VA, Italy

AOU Integrata Verona Policlinico GB

Verona, VR, Italy

U.O. di Oncologia Medica Azienda Ospedaliera G Rummo

Benevento, Italy

PO A Perrino ASL Brindisi - UOC Oncologia Medica

Brindisi, Italy

AOU Policlinico Vittorio Emanuele UOC di Oncologia

Catania, Italy

U.O. di Oncologia Ospedale Villa Scassi

Genova, Italy

Intstituto Scientifico Romangnolo

Meldola, Italy

European Institute of Oncology

Milan, Italy

U.O.C. di Oncologia U.L.S.S. 13

Mirano, Italy

Azienda Ospedaliera di Rilievo Nazionale

Naples, Italy

Dott. Fortunato Ciardiello,Cattedra Oncologia Medica

Naples, Italy

Unita Sperimentazioni Cliniche Istituto per lo

Naples, Italy

Universita Federico II UOC Oncologia Medica

Naples, Italy

UOC Oncologia Medica II Instituto Oncologio Veneto

Padova, Italy

Azienda USL di Piacenza, Ospedale Gugliemimo Salieto

Piacenza, Italy

Azienda Ospedaliera S. Camillo-Forlanin

Rome, Italy

Japanese Red Cross Nagoya Daiichi Hospital

Nagoya, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Hospital of the University of Occupational and

Kitakyushu, Fukuoka, Japan

Gifu Univiesity Hospital

Gifu, Gifu, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

National Hospital Organization Kure Medical Center

Kure, Hiroshima, Japan

Koube University Hospital

Kobe, Hyōgo, Japan

Hyogo College of Medicine

Nishinomiya-shi, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Kansai Medical University Hospital

Hirakata, Osaka, Japan

Kinki University Hospital Faculty of Medicine

Ōsaka-sayama, Osaka, Japan

National Hospital Organization Kinki-Chuo

Sakai, Osaka, Japan

Tottori University Hospital

Yonago, Tottori, Japan

National Hospital Organization Yamaguchi

Ube, Yamaguchi, Japan

Chiba University Hospital

Chiba, Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Japan

Hiroshima University Hospital

Hiroshima, Japan

Osaka City General Hospital

Osaka, Japan

Osaka International Cancer Institute

Osaka, Japan

Juntendo University Hospital

Tokyo, Japan

Tokyo Medical University Hospital

Tokyo, Japan

Kanagawa Cancer Center

Yokohama, Japan

Universitair medisch centrum Nijmegen st Radboud

Nijmegen, Gelderland, Netherlands

Amphia ziekenhuis

Breda, North Brabant, Netherlands

Tergooi locatie Hilversum

Hilversum, North Holland, Netherlands

Isala

Zwolle, Overijssel, Netherlands

Netherlands Cancer Institute

Amsterdam, Netherlands

Free University Hospital

Amsterdam, Netherlands

UMC Groningen

Groningen, Netherlands

Academical Hospital Maastricht

Maastricht, Netherlands

Erasmus Medical Center (EMC)

Rotterdam, Netherlands

Christchurch Hospital

Christchurch, New Zealand

Klinika Onkologii i Radioterapii Uniwersyteckie

Gdansk, Poland

Specjalistyczny Szpital im

Szczecin, Poland

Samodzielny Publiczny Szpital Specjalistyczny

Zakopane, Poland

Conformal Med Terra HIFU

Bucharest, Romania

Spitalul de Psihiatrie Dr. Constantin Gorgos

Bucharest, Romania

Oncology Institute Bucharest

Bucharest, Romania

Oncological Institute "Ion Chiricuta"

Cluj-Napoca, Romania

OCH - Ovidius Clinical Hospital

Constanța, Romania

Centrul de Oncologie Sf Nectarie

Craiova, Romania

SC Oncolab SRL

Craiova, Romania

Spital Lotus SRL

Ploieşti, Romania

National University Hospital

Singapore, Singapore

Keimyung University Dongsan Medical Center

Daegu, Dalseogu, South Korea

Chung Ang University Hospital

Seoul, Dongjak Gu, South Korea

Veterans Health Service Medical Center

Seoul, Gangdong-gu, South Korea

The Catholic University of Korea Bucheon

Bucheon-si, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Uijeongbu ST Marys Hospital

Gyeonggi-do, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

The Catholic University of Korea,

Seoul, South Korea

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Mutua de Terrassa

Terrassa, Barcelona, Spain

Hospital Insular de Gran Canaria

Las Palmas, Gran Canaria, Spain

Hospital Teresa Herrera

A Coruña, Spain

Hospital General de Alicante

Alicante, Spain

Hoapital Quiron Dexeus

Barcelona, Spain

Hospital Vall d Hebron

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Duran i Reynals

Barcelona, Spain

Complejo Asistencial Universitario de Leon

León, Spain

Hospital Universitario la Princesa

Madrid, Spain

Hospital Puerta de Hierro

Madrid, Spain

Fundacion Jimenez Diaz

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Son Llatzer

Palma de Mallorca, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Far Eastern Memorial Hospital

New Taipei City;, Taiwan, Taiwan

Chang-Gung Memorial Hospital - Chiayi

Chiayi City, Taiwan

Kaohsiung Medical University

Kaohsiung City, Taiwan

E-Da Hospital

Kaohsiung City, Taiwan

Chang-Gung Memorial Hospital - Kaohsiung

Kaohsiung City, Taiwan

Taipei Medical University - Shuang Ho Hospital

New Taipei City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

Veterans General Hospital - Taipei

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Chang-Gung Memorial Hospital - Linkou

Taoyuan District, Taiwan

Dnipropetrovsk City Clinical Hospital No.4

Dnipropetrovsk, Ukraine

Regional Oncology Center

Sumy, Ukraine

Vinnytsia Regional Clinical Oncology Dispensary

Vinnitsia, Ukraine