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

October 25, 2023 updated by: Canadian Cancer Trials Group

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

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1415

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Adelaide, Australia, 5042
        • Flinders Medical Center
      • Garran, Australia, ACT 2605
        • Canberra Hospital
      • Victoria Park, Australia, 3065
        • St. Vincent's Hospital
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Campbelltown Hospital
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Coffs Harbour, New South Wales, Australia, 2450
        • Coffs Habour Health Campus - NCCI
      • Gosford, New South Wales, Australia, 2250
        • Gosford Hospital
      • Kingswood, New South Wales, Australia, 2751
        • Nepean Hospital
      • Kogarah, New South Wales, Australia, 2217
        • St. George Hospital, Cancer Care Centre
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Cancer Therapy Centre, Liverpool Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Northern Cancer Institute St Leonards
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast University Hospital
      • Brisbane, Queensland, Australia, 4102
        • Princess Alexandra Hospital
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • South, QLD
      • Brisbane, South, QLD, Australia, 4101
        • Mater Medical Centre
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital - Peninsula Oncology Centre
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital Research Foundation
      • Richmond, Victoria, Australia, 3121
        • Epworth HealthCare - Richmond
      • Wodonga, Victoria, Australia, 3690
        • Border Medical Oncology
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
      • Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Subiaco, Western Australia, Australia, 6008
        • St John of God Subiaco
      • Rio de Janeiro, Brazil, 20231050
        • Instituto Nacional de Cancer (INCA)
    • Ceara
      • Fortaleza, Ceara, Brazil, 60810180
        • Suporte Nutricional e Quimioterapia LTDA PRONUTRIR
    • Espirito Santo
      • Cachoeiro de Itapemirim, Espirito Santo, Brazil, 29308020
        • Hospital Evangelico de Cachoeiro de Itapemirim
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-022
        • Cetus Hospital Dia Oncologia
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59075740
        • Liga Norte Riograndense Contra o Câncer
    • Rio Grande Do Sul
      • Bento Goncalves, Rio Grande Do Sul, Brazil, 95700068
        • Instituto Tacchini de Pesquisa em Saude
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90110270
        • Centro de Oncologia e Radioterapia (COR) Mae de Deus
    • Santa Catarina
      • Itajai, Santa Catarina, Brazil, 88301220
        • Clínica de Neoplasias Litoral
    • Santo Andre
      • Sao Paulo, Santo Andre, Brazil, 09060870
        • Faculdade de Medicina do ABC
    • Sao Paulo
      • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina
      • Sofia, Bulgaria, 1784
        • Medical Centre Synexus
      • Sofia, Bulgaria, 1003
        • MHAT Serdika - Medical Oncology Clinic
      • Sofia, Bulgaria, 1330
        • MHAT Nadezhda Hospital
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 0C2
        • BCCA - Abbotsford Centre
      • Surrey, British Columbia, Canada, V3V 1Z2
        • BCCA - Fraser Valley Cancer Centre
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA - Vancouver Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • The Moncton Hospital
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Regional Health Authority B, Zone 2
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Dr. H. Bliss Murphy Cancer Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • QEII Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre
      • London, Ontario, Canada, N6A 5W9
        • London Regional Cancer Program
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Stronach Regional Health Centre at Southlake
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Research Institute
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Algoma District Cancer Program
      • St. Catharines, Ontario, Canada, L2S 0A9
        • Niagara Health System
      • Sudbury, Ontario, Canada, P3E 5J1
        • Health Sciences North
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Sciences Centre/Thunder
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network
      • Toronto, Ontario, Canada, M3M 0B2
        • Humber River Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Sinai Health System
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 8T5
        • PEI Cancer Treatment Centre
    • Quebec
      • Levis, Quebec, Canada, G6V 3Z1
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM-Centre Hospitalier de l'Universite de Montreal
      • Montreal, Quebec, Canada, H4A 3J1
        • The Research Institute of the McGill University
      • Montreal, Quebec, Canada, H3T 1E2
        • The Jewish General Hospital
      • Montreal, Quebec, Canada, H4J 1C5
        • Centre Integre Universitaire De Sante Et De Services
      • Quebec City, Quebec, Canada, G1V 4G5
        • University Institute of Cardiology and
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Province Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital
      • Shantou, Guangdong, China, 515041
        • The Second Affiliated Hosp of Shantou Medical Colleg
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The People Hospital of Guangxi Zhuang Autonomous Reg
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Province Cancer Hospital
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South Univer
      • Yueyang, Hunan, China, 414000
        • The First People Hospital of Yueyang
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Nanjing General Hospital
      • Xuzhou, Jiangsu, China, 221000
        • The Affiliated Hospital of Xuzhou Medical College
      • Xuzhou, Jiangsu, China, 221000
        • Xuzhou Central Hospital
      • Yangzhou, Jiangsu, China, 225000
        • Northern Jiangsu People Hospital
    • Shandong
      • Jinan, Shandong, China, 250000
        • Shandong Cancer Hospital
      • Qingdao, Shandong, China, 266003
        • The Affiliated Hospital of Qingdao University
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Yunnan Provincial Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir run run shaw hospital School of Medicine
      • Angers, France, 49033
        • CHU - Angers
      • Avignon, France, 84000
        • Institut Sainte Catherine
      • Avignon, France, 84000
        • Centre Hospitalier - Avignon
      • Bayonne, France, 64100
        • Bayonne - Centre Hospitalier
      • Besancon Cedex, France, 25030
        • Hopital Jean Minjoz
      • Bobigny, France, CEDEX 93009
        • Hopital Avicenne
      • Bordeaux, France, 33077
        • Polyclinique Bordeaux Nord
      • Boulogne, France, 92104
        • Boulogne - Ambroise Paré
      • Caen, France, 14000
        • Caen - CHU
      • Chambery, France, 73000
        • Centre Hospitalier de Chambéry
      • Cholet, France, 49325
        • Centre Hospitalier de Cholet
      • Clamart, France, 92141
        • HIA Percy
      • Clermont-Ferrand, France, 63003
        • Clermont-Ferrand - CHU
      • Colmar, France, 68024
        • Hôpital Louis Pasteur
      • Contamine Sur Arve, France, 74130
        • Annemasse - Centre Hospitalier Alpes Leman
      • Corbeil-Essonnes, France, 91100
        • Centre Hospitalier Sud Francilien
      • Creteil, France, 94000
        • Centre Hospitalier Intercommunal de Créteil
      • Dijon, France, 21079
        • CHU Hôpital du Bocage
      • Elbeuf, France, 76503
        • Centre Hospitalier Intercommunal - Elbeuf
      • La Roche Sur Yon, France, 85925
        • Centre Hospitalier departemental
      • Le Chesnay, France, 78157
        • Versailles - CH Andre Mignot
      • Le Mans, France, 72037
        • Centre Hospitalier du Mans
      • Lille, France, 59037
        • Lille - Hôpital Calmette
      • Lyon, France, 69495
        • Centre Hospitalier Lyon Sud
      • Macon, France, 71018
        • Centre Hospitalier les Chanaux
      • Marseille, France, 13915
        • Marseille - Hopital Nord
      • Marseille, France, 13291
        • Hôpital Européen
      • Metz-Tessy, France, 74370
        • CH de la Region d'Annecy
      • Mulhouse, France, 68070
        • Centre Hospitalier de Mulhouse
      • Nice, France, 06189
        • Centre Antoine Lacassagne - Nice
      • Orleans, France, 45000
        • Centre Hospitalier Regional Hopital de la Source
      • Paris, France, 75010
        • Hôpital Saint Louis
      • Paris, France, 75877
        • Hôpital Bichat
      • Paris, France, 75014
        • Fondation Hôpital Saint Joseph
      • Paris, France, 75015
        • Paris - HEGP
      • Paris Cedex 5, France, 75248
        • Paris - Institut Curie
      • Pau, France, 64000
        • Centre Hospitalier General de Pau
      • Perigueux, France, 24019
        • Centre Hospitalier De Perigueux
      • Pontoise, France, 95301
        • Centre Hospitalier René Dubos
      • Rouen, France, 76031
        • CHU de Rouen
      • Saint-Quentin, France, 02100
        • Centre Hospitalier de Saint-Quentin
      • Saint-priest-en-jarez, France, 42271
        • Institut de Cancerologie de la Loire
      • Strasbourg, France, 67091
        • Nouvel Hopital Civil Hopitaux
      • Suresnes, France, 92151
        • Suresnes - Foch
      • Thonon Les Bains, France, 74203
        • Thonon-les-Bains - Hopital Georges Pianta
      • Toulon, France, 83056
        • CHITS Toulon Sainte Musse
      • Toulouse, France, 31059
        • Hôpital Larrey
      • Villefranche Sur Saone, France, 69655
        • Villefranche sur Saône - CH
    • BP
      • Marseille Cedex, BP, France, 156
        • CRLCC - Paoli-Calmette
    • Cedex 04
      • Lyon, Cedex 04, France, 69317
        • Hôpital de la Croix-Rousse
    • Cedex 05
      • Montpellier, Cedex 05, France, 34295
        • Centre Hospitalier Universitaire de Montpellier
    • Cedex 20
      • Paris, Cedex 20, France, 75970
        • AP-HP Hôpital Tenon
    • Cedex 9
      • Grenoble, Cedex 9, France, 38043
        • Hôpital Albert Michallon
    • Tours Cedex 9
      • Tours Cedex, Tours Cedex 9, France, 37044
        • CHRU de Tours - Hôpital Bretonneau
      • Budapest, Hungary, 1125
        • Semmelweis University Pulmonology Department
      • Benevento, Italy, 82100
        • U.O. di Oncologia Medica Azienda Ospedaliera G Rummo
      • Brindisi, Italy, 72100
        • PO A Perrino ASL Brindisi - UOC Oncologia Medica
      • Catania, Italy, 95125
        • AOU Policlinico Vittorio Emanuele UOC di Oncologia
      • Genova, Italy, 16149
        • U.O. di Oncologia Ospedale Villa Scassi
      • Meldola, Italy, 47014
        • Intstituto Scientifico Romangnolo
      • Milan, Italy, 20141
        • European Institute of Oncology
      • Mirano, Italy, 30035
        • U.O.C. di Oncologia U.L.S.S. 13
      • Napoli, Italy, 80131
        • Azienda Ospedaliera di Rilievo Nazionale
      • Napoli, Italy, 80131
        • Dott. Fortunato Ciardiello,Cattedra Oncologia Medica
      • Napoli, Italy, 80131
        • Unita Sperimentazioni Cliniche Istituto per lo
      • Napoli, Italy, 80131
        • Universita Federico II UOC Oncologia Medica
      • Padova, Italy, 35128
        • UOC Oncologia Medica II Instituto Oncologio Veneto
      • Piacenza, Italy, 29100
        • Azienda USL di Piacenza, Ospedale Gugliemimo Salieto
      • Rome, Italy, 00152
        • Azienda Ospedaliera S. Camillo-Forlanin
    • AN
      • Torrette, AN, Italy, 60126
        • Aou Ospedali Riuniti Umberto I
    • AV
      • Avellino, AV, Italy, 83100
        • Azienda Ospedaliera San Giuseppe Moscati
    • BA
      • Bari, BA, Italy, 70124
        • IRCCS Ospedale Oncologico Giovanni Paolo II
    • Lombardia
      • Rozzano (MI), Lombardia, Italy, 20089
        • Instituto Clinico Humanitas
    • MI
      • Milano, MI, Italy, 20142
        • Ospedale S. Paolo - U.O. di Oncologia Medica
    • PG
      • Perugia, PG, Italy, 06129
        • Azienda Ospedaliera di Perugia Santa Maria
    • PN
      • Aviano, PN, Italy, 33081
        • Centro di Riferimento Oncologico - CRO
    • PV
      • Pavia, PV, Italy, 27100
        • Fondazione Salvatore Maugeri Oncologia Medica
    • RA
      • Ravenna, RA, Italy, 48121
        • OUC Oncologia Medica - Presidio Ospedaliero
    • RE
      • Reggio Emilia, RE, Italy, 42123
        • Oncologia Medica IRCCS Arcispedale Maria
    • RM
      • Rome, RM, Italy, 00144
        • Istituti Fisioterapici Ospitalieri IFO Istituto
    • VA
      • Saronno, VA, Italy, 21047
        • A.O. Busto Arsizio - P.O. Saronno
    • VR
      • Verona, VR, Italy, 37134
        • AOU Integrata Verona Policlinico GB
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
      • Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Osaka, Japan, 534-0021
        • Osaka City General Hospital
      • Osaka, Japan, 537-8511
        • Osaka International Cancer Institute
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Yokohama City, Japan, 241-0815
        • Kanagawa Cancer Center
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
        • Nagoya University Hospital
      • Nagoya, Aichi, Japan, 453-8511
        • Japanese Red Cross Nagoya Daiichi Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Hospital of the University of Occupational and
    • Gifu
      • Gifu-shi, Gifu, Japan, 501-1194
        • Gifu Univiesity Hospital
    • Gunma
      • Maebashi-shi, Gunma, Japan, 371-8511
        • Gunma University Hospital
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0023
        • National Hospital Organization Kure Medical Center
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Koube University Hospital
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Hyogo College of Medicine
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-0873
        • Sendai Kousei Hospital
    • Okayama
      • Kurashiki, Okayama, Japan, 710-8602
        • Kurashiki Central Hospital
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital
      • Osaka-Sayama, Osaka, Japan, 589-8511
        • Kinki University Hospital Faculty of Medicine
      • Sakai, Osaka, Japan, 591-8555
        • National Hospital Organization Kinki-Chuo
    • Tottori
      • Yonago, Tottori, Japan, 683-8504
        • Tottori University Hospital
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-0241
        • National Hospital Organization Yamaguchi
      • Gyeonggi-do, Korea, Republic of, 11765
        • Uijeongbu ST Marys Hospital
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea,
    • Chungcheongbuk Do
      • Cheongju, Chungcheongbuk Do, Korea, Republic of, 362-711
        • Chungbuk National University Hospital
    • Dalseogu
      • Daegu, Dalseogu, Korea, Republic of, 42601
        • Keimyung University Dongsan Medical Center
    • Dongjak Gu
      • Seoul, Dongjak Gu, Korea, Republic of, 156-755
        • Chung Ang University Hospital
    • Gangdong-gu
      • Seoul, Gangdong-gu, Korea, Republic of, 134-791
        • Veterans Health Service Medical Center
    • Gyeonggi Do
      • Bucheon, Gyeonggi Do, Korea, Republic of, 420-717
        • The Catholic University of Korea Bucheon
      • Suwon, Gyeonggi Do, Korea, Republic of, 443-380
        • Ajou University Hospital
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute
      • Amsterdam, Netherlands
        • Free University Hospital
      • Groningen, Netherlands, 9713 GZ
        • UMC Groningen
      • Maastricht, Netherlands, 622G HX
        • Academical Hospital Maastricht
      • Rotterdam, Netherlands
        • Erasmus Medical Center (EMC)
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Universitair medisch centrum Nijmegen st Radboud
    • Noord Brabant
      • Breda, Noord Brabant, Netherlands, 4818 CK BREDA
        • Amphia ziekenhuis
    • Noord Holland
      • Hilversum, Noord Holland, Netherlands, 1213XZ
        • Tergooi locatie Hilversum
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 AB
        • Isala
      • Christchurch, New Zealand
        • Christchurch Hospital
      • Gdansk, Poland, 80-214
        • Klinika Onkologii i Radioterapii Uniwersyteckie
      • Szczecin, Poland, 70 891
        • Specjalistyczny Szpital im
      • Zakopane, Poland, 34 500
        • Samodzielny Publiczny Szpital Specjalistyczny
      • Bucharest, Romania
        • Oncology Institute Bucharest
      • Bucharest, Romania, 031864
        • Conformal Med Terra HIFU
      • Bucharest, Romania, 30447
        • Spitalul de Psihiatrie Dr. Constantin Gorgos
      • Cluj-Napoca, Romania, 3400
        • Oncological Institute "Ion Chiricuta"
      • Constanta, Romania, 905900
        • OCH - Ovidius Clinical Hospital
      • Craiova, Romania, 200385
        • Sc Oncolab Srl
      • Craiova, Romania, 200347
        • Centrul De Oncologie Sf Nectarie
      • Ploiesti, Romania, 100011
        • Spital Lotus SRL
      • Singapore, Singapore, 119074
        • National University Hospital
      • Alicante, Spain, 03010
        • Hospital General de Alicante
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08907
        • Hospital Duran I Reynals
      • Barcelona, Spain, 08035
        • Hospital Vall D Hebron
      • Barcelona, Spain, 08028
        • Hoapital Quiron Dexeus
      • Coruna, Spain, 15006
        • Hospital Teresa Herrera
      • Leon, Spain, 24071
        • Complejo Asistencial Universitario de León
      • Madrid, Spain, 28040
        • Fundación Jiménez Díaz
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28035
        • Hospital Puerta de Hierro
      • Palma de Mallorca, Spain, 07198
        • Hospital Son Llatzer
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Mutua de Terrassa
    • Gran Canaria
      • Las Palmas, Gran Canaria, Spain, 35016
        • Hospital Insular de Gran Canaria
      • Chiayi City, Taiwan, 613
        • Chang-Gung Memorial Hospital - Chiayi
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University
      • Kaohsiung, Taiwan, 833
        • Chang-Gung Memorial Hospital - Kaohsiung
      • Kaohsiung City, Taiwan, 82445
        • E-Da hospital
      • New Taipei City, Taiwan, 235
        • Taipei Medical University - Shuang Ho Hospital
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • Taipei, Taiwan, 112
        • Veterans General Hospital - Taipei
      • Taoyuan, Taiwan, 333
        • Chang-Gung Memorial Hospital - Linkou
    • Taiwan;
      • New Taipei City;, Taiwan;, Taiwan, 220
        • Far Eastern Memorial Hospital
      • Dnipropetrovsk, Ukraine, 49102
        • Dnipropetrovsk City Clinical Hospital No.4
      • Sumy, Ukraine, 40004
        • Regional Oncology Center
      • Vinnitsia, Ukraine, 21029
        • Vinnytsia Regional Clinical Oncology Dispensary
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
    • California
      • Los Angeles, California, United States, 9003308
        • USC Norris/Comprehensive Cancer Centre
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Florida
      • Gainesville, Florida, United States, 32610-0277
        • University of Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Dunmore, Pennsylvania, United States, 18512
        • Hematology and Oncology Associates of NEPA
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • West Reading, Pennsylvania, United States, 19611
        • The Reading Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung. according to WHO Classification of Tumours (WHO Classification of Tumours of the Lung, Pleura, Thymus and Heart. WHO/IARC Classification of Tumours, 4th Edition, Volume 7). Patients with large-cell neuroendocrine carcinomas are not eligible.
  • Patients must be classified post-operatively as Stage IB (≥ 4cm in the longest diameter), II or IIIA on the basis of pathologic criteria. Note: Although T3N2M0 tumours have been reclassified to stage IIIB in the 8th edition of the IASLC staging system, these patients remain eligible (as stage IIIA under the 7th edition criteria).

    • Complete surgical resection of the primary NSCLC is also mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour. Resection may be accomplished by open or VATS techniques

Note: Patients with synchronous primary tumours will not be eligible due to the potential uncertainty regarding their appropriate PD-L1 status.

Prior Systemic Therapy:

  • Pre-operative (neo-adjuvant) platinum based or other chemotherapy is not permissible.
  • Patients may have received prior post-operative platinum based chemotherapy as per standard of care.
  • No prior anticancer therapy for treatment of NSCLC other than standard post-operative adjuvant chemotherapy is permissible.

Radiation:

• Patients with N2 disease only who receive adjuvant post-operative radiation therapy are eligible provided they meet the protocol specified timing criteria for surgery, adjuvant chemotherapy and randomization. Pre-operative radiation therapy is not permissible.

  • The patient must have an ECOG performance status of 0, 1.
  • Hematology: . Absolute neutrophil count ≥ 1.5 x 109/L or ≥ 1,500/µl Platelets ≥ 100 x 109/L or ≥ 100,000/µl
  • Biochemistry:

Total bilirubin* ≤ institutional upper limit of normal Alkaline phosphatase ≤ 2.5 x institutional upper limit of normal AST(SGOT) and ALT(SGPT) ≤ 2.5 x institutional upper limit of normal Creatinine Clearance ≥ 40 ml/min

* excluding Gilbert's syndrome

Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula:

Females: GFR = 1.04 x (140-age) x weight in kg serum creatinine in μmol/L Males: GFR = 1.23 x (140-age) x weight in kg serum creatinine in μmol/L

  • Patient able and willing to complete the QoL, economics and other questionnaires. The baseline assessment must already have been completed within required timelines prior to randomization. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
  • Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
  • Protocol treatment is to begin within 2 working days of patient randomization

Exclusion Criteria:

  • Patients with a history of other malignancies, except:

    • adequately treated non-melanoma skin cancer,
    • curatively treated in-situ cancer, or
    • other malignancies curatively treated with no evidence of disease for ≥ 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
  • A combination of small cell and non-small cell lung cancer, pulmonary carcinoid tumour or large-cell neuroendocrine carcinoma (LCNEC).
  • History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. NOTE: patients with Grave's disease and/or psoriasis not requiring systemic therapy within the last two years from randomization and patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement are not excluded.
  • History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
  • Live attenuated vaccination administered within 30 days prior to randomization.
  • History of hypersensitivity to MEDI4736 or any excipient.
  • Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, must have a LVEF > 50% within 12 weeks prior to randomization.
  • Concurrent treatment with other investigational drugs or anti-cancer therapy.
  • Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to:

    • known clinical diagnosis of tuberculosis;
    • known active hepatitis B infection (positive HBV surface antigen (HBsAg)). Patients with a past or resolved hepatitis B infection (defined as presence of hepatitis B core antibody (anti-HBc) and absence of HBSAg) are eligible;
    • known active hepatitis C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA;
    • known human immunodeficiency virus infection (positive HIV antibodies).
    • known pneumonitis or pulmonary fibrosis with clinically significant impairment of pulmonary function
  • Pregnant or lactating women. Women of childbearing potential must have a urine pregnancy test proven negative within 14 days prior to randomization. Men and women of child-bearing potential must agree to use adequate contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MEDI4736
MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier.
Placebo Comparator: Placebo
PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare Disease free survival (DFS) for patients with NSCLC that is PD-L1 expression TC ≥ 25% and patients without common activating EGFR mutations or ALK gene rearrangements
Time Frame: 6.7 years
6.7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival in the remaining 5 patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Time Frame: 8 years
(PD-L1 TC ≥ 1% and patients without common activating EGFR mutations or ALK gene rearrangements; all patients without common activating EGFR mutations or ALK gene rearrangements; all PD-L1 TC ≥ 25%; all PD-L1 TC ≥ 1%; all randomized patients)
8 years
Compare overall survival (OS) for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Time Frame: 8 years
8 years
Compare Lung cancer specific survival for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Time Frame: 8 years
8 years
Evaluate the nature, severity and frequency of adverse effects and tolerability of MEDI4736
Time Frame: every 6 months
All patients who receive at least one dose of MEDI4376/placebo will be included in the safety analysis. Descriptive summary tables will be presented on safety parameters by treatment arm. There will be safety monitoring by the CCTG Data Safety Monitoring Committee (DSMC) every 6 months
every 6 months
Evaluate the Quality of life in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Time Frame: 8 years
The quality of life (QoL) of patients will be assessed using EORTC QLQ-C30 and the lung cancer module (QLQ-LC13) incorporated.
8 years
Determine survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile
Time Frame: 8 years
8 years
Determine the incremental cost effectiveness and cost utility ratios for MEDI4736
Time Frame: 8 years
8 years
Evaluate the predictive/prognostic significance of PD-L1 expression
Time Frame: 8 years
8 years
Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event
Time Frame: 8 years
8 years
Explore polymorphisms that may be associated with outcomes
Time Frame: Baseline only
Baseline only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2015

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimated)

October 24, 2014

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • BR31
  • IFCT1401 (Other Identifier: Intergroupe Francophone de Cancerologie Thoracique (IFCT))
  • ACTRN12615000323527 (Registry Identifier: Australian New Zealand Clinical Trials Registry)
  • U1111-1238-5923 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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