AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3NCT02273375

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

A Phase 3 study testing MEDI4736 in people with Non-Small Cell Lung Cancer, run by Canadian Cancer Trials Group at 271 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
MEDI4736
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,415 participants
Where
271 sitesin 19 countries
Study dates
24 Feb 2015to 1 Sep 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

271 sites in 19 countries.

271 sites in 19 countries

France54 sites

  • CHU - Angers

    Angers, 49033

  • Centre Hospitalier - Avignon

    Avignon, 84000

  • Institut Sainte Catherine

    Avignon, 84000

  • Bayonne - Centre Hospitalier

    Bayonne, 64100

  • Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Avicenne

    Bobigny, CEDEX 93009

  • Polyclinique Bordeaux Nord

    Bordeaux, 33077

  • Boulogne - Ambroise Pare

    Boulogne, 92104

  • Caen - CHU

    Caen, 14000

  • Centre Hospitalier de Chambery

    Chambéry, 73000

  • Centre Hospitalier de Cholet

    Cholet, 49325

  • HIA Percy

    Clamart, 92141

  • Clermont-Ferrand - CHU

    Clermont-Ferrand, 63003

  • Hopital Louis Pasteur

    Colmar, 68024

  • Annemasse - Centre Hospitalier Alpes Leman

    Contamine-sur-Arve, 74130

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91100

  • Centre Hospitalier Intercommunal de Creteil

    Créteil, 94000

  • CHU Hopital du Bocage

    Dijon, 21079

  • Centre Hospitalier Intercommunal - Elbeuf

    Elbeuf, 76503

  • Hopital Albert Michallon

    Grenoble, Cedex 9, 38043

  • Centre Hospitalier departemental

    La Roche-sur-Yon, 85925

  • Versailles - CH Andre Mignot

    Le Chesnay, 78157

  • Centre Hospitalier du Mans

    Le Mans, 72037

  • Lille - Hopital Calmette

    Lille, 59037

  • Hopital de la Croix-Rousse

    Lyon, Cedex 04, 69317

  • Centre Hospitalier Lyon Sud

    Lyon, 69495

  • Centre Hospitalier les Chanaux

    Mâcon, 71018

  • CRLCC - Paoli-Calmette

    Marseille, BP, 156

  • Hopital Europeen

    Marseille, 13291

  • Marseille - Hopital Nord

    Marseille, 13915

  • CH de la Region d'Annecy

    Metz-Tessy, 74370

  • Centre hospitalier universitaire de Montpellier

    Montpellier, Cedex 05, 34295

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68070

  • Centre Antoine Lacassagne - Nice

    Nice, 06189

  • Centre Hospitalier Regional Hopital de la Source

    Orléans, 45000

  • AP-HP Hopital Tenon

    Paris, Cedex 20, 75970

  • Hopital Saint Louis

    Paris, 75010

  • Fondation Hopital Saint Joseph

    Paris, 75014

  • Paris - HEGP

    Paris, 75015

  • Paris - Institut Curie

    Paris, 75248

  • Hopital Bichat

    Paris, 75877

  • Centre Hospitalier General de Pau

    Pau, 64000

  • Centre Hospitalier de Perigueux

    Périgueux, 24019

  • Centre Hospitalier Rene Dubos

    Pontoise, 95301

  • CHU de Rouen

    Rouen, 76031

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42271

  • Centre Hospitalier de Saint-Quentin

    Saint-Quentin, 02100

  • Nouvel Hopital Civil Hopitaux

    Strasbourg, 67091

  • Suresnes - Foch

    Suresnes, 92151

  • Thonon-les-Bains - Hopital Georges Pianta

    Thonon-les-Bains, 74203

  • CHITS Toulon Sainte Musse

    Toulon, 83056

  • Hopital Larrey

    Toulouse, 31059

  • CHRU de Tours - Hopital Bretonneau

    Tours, Tours Cedex 9, 37044

  • Villefranche sur Saone - CH

    Villefranche-sur-Saône, 69655

Other trials in France

Canada33 sites

  • BCCA - Abbotsford Centre

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • PEI Cancer Treatment Centre

    Charlottetown, Prince Edward Island, C1A 8T5

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • Study site

    Lévis, Quebec, G6V 3Z1

  • London Regional Cancer Program

    London, Ontario, N6A 5W9

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • The Research Institute of the McGill University

    Montreal, Quebec, H4A 3J1

  • Centre Integre Universitaire De Sante Et De Services

    Montreal, Quebec, H4J 1C5

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • University Institute of Cardiology and

    Québec, Quebec, G1V 4G5

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Regional Health Authority B, Zone 2

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Algoma District Cancer Program

    Sault Ste. Marie, Ontario, P6B 0A8

  • Niagara Health System

    St. Catharines, Ontario, L2S 0A9

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Thunder Bay Regional Health Sciences Centre/Thunder

    Thunder Bay, Ontario, P7B 6V4

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Sinai Health System

    Toronto, Ontario, M5G 1X5

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Japan28 sites

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Gifu Univiesity Hospital

    Gifu, Gifu, 501-1194

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima, 730-8518

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Hospital of the University of Occupational and

    Kitakyushu, Fukuoka, 807-8556

  • Koube University Hospital

    Kobe, Hyōgo, 650-0017

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken, 710-8602

  • National Hospital Organization Kure Medical Center

    Kure, Hiroshima, 737-0023

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Japanese Red Cross Nagoya Daiichi Hospital

    Nagoya, Aichi-ken, 453-8511

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Hyogo College of Medicine

    Nishinomiya-shi, Hyōgo, 663-8501

  • Osaka City General Hospital

    Osaka, Osaka, 534-0021

  • Osaka International Cancer Institute

    Osaka, Osaka, 537-8511

  • Kinki University Hospital Faculty of Medicine

    Ōsaka-sayama, Osaka, 589-8511

  • National Hospital Organization Kinki-Chuo

    Sakai, Osaka, 591-8555

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873

  • Juntendo University Hospital

    Tokyo, Tokyo, 113-8431

  • Tokyo Medical University Hospital

    Tokyo, Tokyo, 160-0023

  • National Hospital Organization Yamaguchi

    Ube, Yamaguchi, 755-0241

  • Kanagawa Cancer Center

    Yokohama, 241-0815

  • Tottori University Hospital

    Yonago, Tottori, 683-8504

Other trials in Japan

Australia27 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders Medical Center

    Adelaide, 5042

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Mater Medical Centre

    Brisbane, South, QLD, 4101

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Coffs Habour Health Campus - NCCI

    Coffs Harbour, New South Wales, 2450

  • Frankston Hospital - Peninsula Oncology Centre

    Frankston, Victoria, 3199

  • Canberra Hospital

    Garran, ACT 2605

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Nepean Hospital

    Kingswood, New South Wales, 2751

  • St. George Hospital, Cancer Care Centre

    Kogarah, New South Wales, 2217

  • Liverpool Cancer Therapy Centre, Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Royal Melbourne Hospital Research Foundation

    Parkville, Victoria, 3050

  • Sir Charles Gairdner Hospital

    Perth, Western Australia, 6009

  • Epworth HealthCare - Richmond

    Richmond, Victoria, 3121

  • Northern Cancer Institute St Leonards

    St Leonards, New South Wales, 2065

  • St John of God Subiaco

    Subiaco, Western Australia, 6008

  • St. Vincent's Hospital

    Victoria Park, Victoria Park, 3065

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Border Medical Oncology

    Wodonga, Victoria, 3690

Other trials in Australia

Italy27 sites

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, AV, 83100

  • Centro di Riferimento Oncologico - CRO

    Aviano, PN, 33081

  • IRCCS Ospedale Oncologico Giovanni Paolo II

    Bari, BA, 70124

  • U.O. di Oncologia Medica Azienda Ospedaliera G Rummo

    Benevento, 82100

  • PO A Perrino ASL Brindisi - UOC Oncologia Medica

    Brindisi, 72100

  • AOU Policlinico Vittorio Emanuele UOC di Oncologia

    Catania, Catania, 95125

  • U.O. di Oncologia Ospedale Villa Scassi

    Genova, 16149

  • Intstituto Scientifico Romangnolo

    Meldola, 47014

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

    Milan, MI, 20142

  • European Institute of Oncology

    Milan, 20141

  • U.O.C. di Oncologia U.L.S.S. 13

    Mirano, 30035

  • Azienda Ospedaliera di Rilievo Nazionale

    Naples, 80131

  • Dott. Fortunato Ciardiello,Cattedra Oncologia Medica

    Naples, 80131

  • Unita Sperimentazioni Cliniche Istituto per lo

    Naples, 80131

  • Universita Federico II UOC Oncologia Medica

    Naples, 80131

  • UOC Oncologia Medica II Instituto Oncologio Veneto

    Padova, 35128

  • Fondazione Salvatore Maugeri Oncologia Medica

    Pavia, PV, 27100

  • Azienda Ospedaliera di Perugia Santa Maria

    Perugia, PG, 06129

  • Azienda USL di Piacenza, Ospedale Gugliemimo Salieto

    Piacenza, 29100

  • OUC Oncologia Medica - Presidio Ospedaliero

    Ravenna, RA, 48121

  • Oncologia Medica IRCCS Arcispedale Maria

    Reggio Emilia, RE, 42123

  • Istituti Fisioterapici Ospitalieri IFO Istituto

    Rome, RM, 00144

  • Azienda Ospedaliera S. Camillo-Forlanin

    Rome, 00152

  • Instituto Clinico Humanitas

    Rozzano (MI), Lombardy, 20089

  • A.O. Busto Arsizio - P.O. Saronno

    Saronno, VA, 21047

  • AOU Ospedali Riuniti Umberto I

    Torrette, AN, 60126

  • AOU Integrata Verona Policlinico GB

    Verona, VR, 37134

Other trials in Italy

China17 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • The Second Xiangya Hospital of Central South Univer

    Changsha, Hunan, 410011

  • Fujian Province Cancer Hospital

    Fuzhou, Fujian, 350014

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • Sir run run shaw hospital School of Medicine

    Hangzhou, Zhejiang, 310016

  • Shandong Cancer Hospital

    Jinan, Shandong, 250000

  • Yunnan Provincial Cancer Hospital

    Kunming, Yunnan, 650118

  • Nanjing General Hospital

    Nanjing, Jiangsu, 210002

  • The People Hospital of Guangxi Zhuang Autonomous Reg

    Nanning, Guangxi, 530021

  • The Affiliated Hospital Of Qingdao University

    Qingdao, Shandong, 266003

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • The Second Affiliated Hosp of Shantou Medical Colleg

    Shantou, Guangdong, 515041

  • The Affiliated Hospital Of Xuzhou Medical College

    Xuzhou, Jiangsu, 221000

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221000

  • Northern Jiangsu People Hospital

    Yangzhou, Jiangsu, 225000

  • The First People Hospital of Yueyang

    Yueyang, Hunan, 414000

  • Henan province Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

Spain17 sites

  • Hospital Teresa Herrera

    A Coruña, Coruna, 15006

  • Hospital General de Alicante

    Alicante, Alicante, 03010

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hoapital Quiron Dexeus

    Barcelona, Barcelona, 08028

  • Hospital Vall d Hebron

    Barcelona, Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041

  • Hospital Duran i Reynals

    Barcelona, Barcelona, 08907

  • Hospital Insular de Gran Canaria

    Las Palmas, Gran Canaria, 35016

  • Complejo Asistencial Universitario de Leon

    León, Leon, 24071

  • Hospital Universitario la Princesa

    Madrid, Madrid, 28006

  • Hospital Puerta de Hierro

    Madrid, Madrid, 28035

  • Fundacion Jimenez Diaz

    Madrid, Madrid, 28040

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040

  • Hospital Son Llatzer

    Palma de Mallorca, Palma de Mallorca, 07198

  • Hospital Universitario de Salamanca

    Salamanca, Salamanca, 37007

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

Other trials in Spain

Taiwan11 sites

  • Chang-Gung Memorial Hospital - Chiayi

    Chiayi City, Taiwan, 613

  • Kaohsiung Medical University

    Kaohsiung, Taiwan, 807

  • Chang-Gung Memorial Hospital - Kaohsiung

    Kaohsiung, Taiwan, 833

  • E-Da Hospital

    Kaohsiung City, Taiwan, 82445

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, Taiwan, 235

  • Far Eastern Memorial Hospital

    New Taipei City;, Taiwan, 220

  • China Medical University Hospital

    Taichung, 404

  • Mackay Memorial Hospital

    Taipei, Taiwan, 104

  • Veterans General Hospital - Taipei

    Taipei, Taiwan, 112

  • Tri-Service General Hospital

    Taipei, 114

  • Chang-Gung Memorial Hospital - Linkou

    Taoyuan, Taiwan, 333

Other trials in Taiwan

Brazil10 sites

  • Cetus Hospital Dia Oncologia

    Belo Horizonte, Minas Gerais, 30110-022

  • Instituto Tacchini de Pesquisa em Saude

    Bento Gonçalves, Rio Grande do Sul, 95700068

  • Hospital Evangelico de Cachoeiro de Itapemirim

    Cachoeiro de Itapemirim, Espírito Santo, 29308020

  • Suporte Nutricional e Quimioterapia LTDA PRONUTRIR

    Fortaleza, Ceará, 60810180

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301220

  • Liga Norte Riograndense Contra o Cancer

    Natal, Rio Grande do Norte, 59075740

  • Centro de Oncologia e Radioterapia (COR) Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90110270

  • Instituto Nacional de Cancer (INCA)

    Rio de Janeiro, Rio de Janeiro, 20231050

  • Fundacao Faculdade Regional de Medicina

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

  • Faculdade de Medicina do ABC

    São Paulo, Santo Andre, 09060870

Other trials in Brazil

United States9 sites

  • National Jewish Health

    Denver, Colorado, 80206

  • Hematology and Oncology Associates of NEPA

    Dunmore, Pennsylvania, 18512

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Florida

    Gainesville, Florida, 32610-0277

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • USC Norris/Comprehensive Cancer Centre

    Los Angeles, California, 9003308

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • The Reading Hospital Medical Center

    West Reading, Pennsylvania, 19611

Other trials in United States

Netherlands9 sites

  • Free University Hospital

    Amsterdam, Netherlands

  • Netherlands Cancer Institute

    Amsterdam, 1066 CX

  • Amphia ziekenhuis

    Breda, North Brabant, 4818 CK BREDA

  • UMC Groningen

    Groningen, Provincie Groningen, 9713 GZ

  • Tergooi locatie Hilversum

    Hilversum, North Holland, 1213XZ

  • Academical Hospital Maastricht

    Maastricht, 622G HX

  • Universitair medisch centrum Nijmegen st Radboud

    Nijmegen, Gelderland, 6525 GA

  • Erasmus Medical Center (EMC)

    Rotterdam, Netherlands

  • Isala

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

South Korea9 sites

  • The Catholic University of Korea Bucheon

    Bucheon-si, Gyeonggi-do, 420-717

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 362-711

  • Keimyung University Dongsan Medical Center

    Daegu, Dalseogu, 42601

  • Uijeongbu ST Marys Hospital

    Gyeonggi-do, Gyeonggi-do, 11765

  • Chung Ang University Hospital

    Seoul, Dongjak gu, 156-755

  • Veterans Health Service Medical Center

    Seoul, Gangdong-gu, 134-791

  • Kangbuk Samsung Hospital

    Seoul, Seoul, 03181

  • The Catholic University of Korea,

    Seoul, 137-701

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 443-380

Other trials in South Korea

Romania8 sites

  • Conformal Med Terra HIFU

    Bucharest, 031864

  • Spitalul de Psihiatrie Dr. Constantin Gorgos

    Bucharest, 30447

  • Oncology Institute Bucharest

    Bucharest

  • Oncological Institute "Ion Chiricuta"

    Cluj-Napoca, 3400

  • OCH - Ovidius Clinical Hospital

    Constanța, 905900

  • Centrul de Oncologie Sf Nectarie

    Craiova, 200347

  • SC Oncolab SRL

    Craiova, 200385

  • Spital Lotus SRL

    Ploieşti, 100011

Other trials in Romania

Bulgaria3 sites

  • MHAT Serdika - Medical Oncology Clinic

    Sofia, 1003

  • MHAT Nadezhda Hospital

    Sofia, 1330

  • Medical Centre Synexus

    Sofia, 1784

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Poland3 sites

  • Klinika Onkologii i Radioterapii Uniwersyteckie

    Gdansk, 80-214

  • Specjalistyczny Szpital im

    Szczecin, 70 891

  • Samodzielny Publiczny Szpital Specjalistyczny

    Zakopane, 34 500

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Ukraine3 sites

  • Dnipropetrovsk City Clinical Hospital No.4

    Dnipropetrovsk, 49102

  • Regional Oncology Center

    Sumy, 40004

  • Vinnytsia Regional Clinical Oncology Dispensary

    Vinnitsia, 21029

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Hungary1 site

  • Semmelweis University Pulmonology Department

    Budapest, Budapest, 1125

Other trials in Hungary

New Zealand1 site

  • Christchurch Hospital

    Christchurch

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Singapore1 site

  • National University Hospital

    Singapore, 119074

Other trials in Singapore

About this study

Official title: 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.

Being tested
MEDI4736, Placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEDI4736Drug

  • PlaceboDrug

Study groups in NCT02273375
Study groupRoleWhat they receive
MEDI4736ExperimentalMEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier.
Receives: Drug: MEDI4736
PlaceboPlacebo comparatorPLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare Disease Free Survival (DFS) for Patients With NSCLC That is PD-L1 Expression TC ≥ 25% and Patients Without EGFR Exon 21 L858R Mutation or Exon 19 Deletions or ALK Gene Rearrangements

    DFS in months is defined as the time from the date of randomization to the date of first documented disease relapse or the occurrence of a new invasive primary malignancy that was later confirmed or death from any cause, whichever came first. For patients who were determined to have residual disease at study entry after consensus review, the DFS were censored at the date of randomization. Patients who are alive and disease/new invasive primary malignancy-free at the data cut-off date will be censored at their last disease assessment date.

    Measured: Up to 8.3 years

Secondary outcomes (7)

  1. Disease-free Survival in Patients With PD-L1 Expression Levels >= 1% and Without Common Activating EGFR Mutations or ALK Gene Rearrangements.

    DFS time in months is defined as the time from the date of randomization to the date of first documented disease relapse or the occurrence of a new invasive primary malignancy that was later confirmed or death from any cause, whichever came first. For patients who were determined to have residual disease at study entry after consensus review, the DFS were censored at the date of randomization. Patients who are alive and disease/new invasive primary malignancy-free at the data cut-off date will be censored at their last disease assessment date.

    Measured: up to 8.3 years

  2. Disease-free Survival in Patients Without Common Activating EGFR Mutations or ALK Gene Rearrangements.

    DFS is defined as the time from the date of randomization to the date of first documented disease relapse or the occurrence of a new invasive primary malignancy that was later confirmed or death from any cause, whichever came first. For patients who were determined to have residual disease at study entry after consensus review, the DFS were censored at the date of randomization. Patients who are alive and disease/new invasive primary malignancy-free at the data cut-off date will be censored at their last disease assessment date.

    Measured: up to 8.3 years

  3. Compare Overall Survival (OS) for Patients in Patients With PD-L1 >= 25% and Without EGFR Exon 21 L858R Mutation or Exon 19 Deletion or ALK Gene Rearrangements.

    OS is defined as the time from the date of randomization to the date of death of any cause or censored at their last known alive date before or on the data cutoff date. Analysis population is for patients in patients with PD-L1 >= 25% and without EGFR exon 21 L858R mutation or exon 19 deletion or ALK gene rearrangements.

    Measured: All randomized patients with a minimum of 5 years follow up and up to 9.7 years.

  4. Compare Overall Survival (OS) for Patients in Patients With PD-L1 >= 1% and Without EGFR Exon 21 L858R Mutation or Exon 19 Deletion or ALK Gene Rearrangements.

    OS is defined as the time from the date of randomization to the date of death of any cause or censored at their last known alive date before or on the data cutoff date. Patients population is for patients with PD-L1 >= 1% and without EGFR exon 21 L858R mutation or exon 19 deletion or ALK gene rearrangements.

    Measured: All randomized patients with a minimum of 5 years follow up and up to 9.7 years.

  5. Compare Overall Survival (OS) for Patients in Patients Without EGFR Exon 21 L858R Mutation or Exon 19 Deletion or ALK Gene Rearrangements.

    OS is defined as the time from the date of randomization to the date of death of any cause or censored at their last known alive date before or on the data cutoff date. Analysis population is all randomized patients without EGFR exon 21 L858R mutation or exon 19 deletion or ALK gene rearrangements.

    Measured: All randomized patients with a minimum of 5 years follow up and up to 9.7 years.

  6. Compare Disease Free Survival (DFS) in All Randomized Patients

    DFS is defined as the time from the date of randomization to the date of first documented disease relapse or the occurrence of a new invasive primary malignancy that was later confirmed or death from any cause, whichever came first. For patients who were determined to have residual disease at study entry after consensus review, the DFS were censored at the date of randomization. Patients who are alive and disease/new invasive primary malignancy-free at the data cut-off date will be censored at their last disease assessment date.

    For a special case, Patient AUAP0005 was found that the original NSCLC diagnosis was erroneous, and the patient had metastatic testicular cancer prior to randomization, confirmed retrospectively by immunophenotyping. Since the patient did not have completely resected NSCLC, the patient was censored at randomization for both DFS and OS.

    Measured: up to 8.3 years

  7. Compare Overall Survival (OS) in All Randomized Patients

    OS is defined as the time from the date of randomization to the date of death of any cause or censored at their last known alive date before or on the data cutoff date.

    Measured: All randomized patients with a minimum of 5 years follow up and up to 9.7 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2014 (estimated)
  2. Study start24 Feb 2015
  3. Primary completion23 Jul 2025
  4. Study completion1 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02273375
Sponsor's protocol ID
BR31
Other IDs
IFCT1401, ACTRN12615000323527, U1111-1238-5923
Status last verified
Sep 2026
First submitted
22 Oct 2014
Last updated
14 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Glenwood D. Goss, MD, FCP(SA), FRCPC 1; Gail E. Darling, MD, FRCS 2 ; Virginie Westeel, MD 3; Kazuhiko Nakagawa, MD, PhD 4; Bartomeu Massut´ı, MD 5 ; Francesco Perrone, MD 6 ; Sue-Anne McLachlan, MBBS, FRACP 7 ; Jin Hyoung Kang, MD 8 ; Yi-Long Wu, MD 9; Anne-Marie C. Dingemans, MD, PhD 10 ; Rafal Dziadziuszko, MD, PhD 11 ; Laurent Greillier, MD, PhD 12 ; Morihito Okada, MD 13 ; Clarisse Audigier-Valette, MD 14 ; Shunichi Sugawara, MD 15 ; Ernest Nadal, MD, PhD 16 ; Annamaria Catino, MD 17;Anne-Claire Toffart, MD, PhD 18 ; Tetsuya Mitsudomi, MD, PhD 19; Renaud Whittom, MD, FRCPC 20 ; Manuel Domine, MD 21; Nobuyuki Yamamoto, MD 22 ; Olivier Molinier, MD 23 ; Franck Morin, MSc 24 ; Penelope A. Bradbury, MD 25 ; Martin R. Stockler, MBBS, FRACP 26 ; Keyue Ding, PhD 27 ; and Christopher J. O'Callaghan, PhD, DVM 27

  • Goss GD, Darling GE, Westeel V, Nakagawa K, Massuti B, Perrone F, McLachlan SA, Kang JH, Wu YL, Dingemans AC, Dziadziuszko R, Greillier L, Okada M, Audigier-Valette C, Sugawara S, Nadal E, Catino A, Toffart AC, Mitsudomi T, Whittom R, Domine M, Yamamoto N, Molinier O, Morin F, Bradbury PA, Stockler MR, Ding K, O'Callaghan CJ. Adjuvant Durvalumab in Completely Resected Early-Stage Non-Small Cell Lung Cancer. J Clin Oncol. 2026 Mar;44(7):553-564. doi: 10.1200/JCO-25-01828. Epub 2026 Jan 13.

    PubMed 41529222

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MEDI4736 in people with Non-Small Cell Lung Cancer, run by Canadian Cancer Trials Group at 271 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 271 sites in France, Canada, Japan, Australia, Italy and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare Disease Free Survival (DFS) for Patients With NSCLC That is PD-L1 Expression TC ≥ 25% and Patients Without EGFR Exon 21 L858R Mutation or Exon 19 Deletions or ALK Gene Rearrangements (time frame: Up to 8.3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02273375, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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