Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC
A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer
4 other identifiers
interventional
1,415
19 countries
271
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Feb 2015
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
271 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedStudy Start
First participant enrolled
February 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedAugust 12, 2025
August 1, 2025
10.4 years
October 22, 2014
August 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
6.7 years
Secondary Outcomes (10)
Disease-free survival in the remaining 5 patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
8 years
Compare overall survival (OS) for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
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
8 years
Evaluate the nature, severity and frequency of adverse effects and tolerability of MEDI4736
every 6 months
Evaluate the Quality of life in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
8 years
- +5 more secondary outcomes
Study Arms (2)
MEDI4736
EXPERIMENTALMEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier.
Placebo
PLACEBO COMPARATORPLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +6 more criteria
You may not qualify if:
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Cancer Trials Grouplead
- Intergroupe Francophone de Cancerologie Thoraciquecollaborator
- Thoracic Oncology Group of Australasia (TOGA)collaborator
- National Health and Medical Research Council, Australiacollaborator
- National Cancer Institute (NCI), Naplescollaborator
- Central and Eastern European Oncology Groupcollaborator
- Dutch Society of Physicians for Pulmonology and Tuberculosiscollaborator
- Korean Cancer Study Groupcollaborator
- Fundación GECPcollaborator
- West Japan Oncology Group (WJOG)collaborator
- Chinese Thoracic Oncology Groupcollaborator
Study Sites (271)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
USC Norris/Comprehensive Cancer Centre
Los Angeles, California, 9003308, United States
National Jewish Health
Denver, Colorado, 80206, United States
University of Florida
Gainesville, Florida, 32610-0277, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Hematology and Oncology Associates of NEPA
Dunmore, Pennsylvania, 18512, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
The Reading Hospital Medical Center
West Reading, Pennsylvania, 19611, United States
Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Coffs Habour Health Campus - NCCI
Coffs Harbour, New South Wales, 2450, Australia
Gosford Hospital
Gosford, New South Wales, 2250, Australia
Nepean Hospital
Kingswood, New South Wales, 2751, Australia
St. George Hospital, Cancer Care Centre
Kogarah, New South Wales, 2217, Australia
Liverpool Cancer Therapy Centre, Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Northern Cancer Institute St Leonards
St Leonards, New South Wales, 2065, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Mater Medical Centre
Brisbane, South, QLD, 4101, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Frankston Hospital - Peninsula Oncology Centre
Frankston, Victoria, 3199, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Royal Melbourne Hospital Research Foundation
Parkville, Victoria, 3050, Australia
Epworth HealthCare - Richmond
Richmond, Victoria, 3121, Australia
Border Medical Oncology
Wodonga, Victoria, 3690, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009, Australia
St John of God Subiaco
Subiaco, Western Australia, 6008, Australia
Flinders Medical Center
Adelaide, 5042, Australia
Canberra Hospital
Garran, ACT 2605, Australia
St. Vincent's Hospital
Victoria Park, 3065, Australia
Suporte Nutricional e Quimioterapia LTDA PRONUTRIR
Fortaleza, Ceará, 60810180, Brazil
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, 29308020, Brazil
Cetus Hospital Dia Oncologia
Belo Horizonte, Minas Gerais, 30110-022, Brazil
Liga Norte Riograndense Contra o Cancer
Natal, Rio Grande do Norte, 59075740, Brazil
Instituto Tacchini de Pesquisa em Saude
Bento Gonçalves, Rio Grande do Sul, 95700068, Brazil
Centro de Oncologia e Radioterapia (COR) Mae de Deus
Porto Alegre, Rio Grande do Sul, 90110270, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301220, Brazil
Faculdade de Medicina do ABC
São Paulo, Santo Andre, 09060870, Brazil
Fundacao Faculdade Regional de Medicina
São José do Rio Preto, São Paulo, 15090-000, Brazil
Instituto Nacional de Cancer (INCA)
Rio de Janeiro, 20231050, Brazil
MHAT Serdika - Medical Oncology Clinic
Sofia, 1003, Bulgaria
MHAT Nadezhda Hospital
Sofia, 1330, Bulgaria
Medical Centre Synexus
Sofia, 1784, Bulgaria
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BCCA - Abbotsford Centre
Abbotsford, British Columbia, V2S 0C2, Canada
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
Regional Health Authority B, Zone 2
Saint John, New Brunswick, E2L 4L2, Canada
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Health Sciences North
Greater Sudbury, Ontario, P3E 5J1, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
London Regional Cancer Program
London, Ontario, N6A 5W9, Canada
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, L3Y 2P9, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
Algoma District Cancer Program
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Niagara Health System
St. Catharines, Ontario, L2S 0A9, Canada
Thunder Bay Regional Health Sciences Centre/Thunder
Thunder Bay, Ontario, P7B 6V4, Canada
Humber River Hospital
Toronto, Ontario, M3M 0B2, Canada
Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Sinai Health System
Toronto, Ontario, M5G 1X5, Canada
University Health Network
Toronto, Ontario, M5G 2M9, Canada
PEI Cancer Treatment Centre
Charlottetown, Prince Edward Island, C1A 8T5, Canada
Unknown Facility
Lévis, Quebec, G6V 3Z1, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
The Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
The Research Institute of the McGill University
Montreal, Quebec, H4A 3J1, Canada
Centre Integre Universitaire De Sante Et De Services
Montreal, Quebec, H4J 1C5, Canada
University Institute of Cardiology and
Québec, Quebec, G1V 4G5, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Fujian Province Cancer Hospital
Fuzhou, Fujian, 350014, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
The Second Affiliated Hosp of Shantou Medical Colleg
Shantou, Guangdong, 515041, China
The People Hospital of Guangxi Zhuang Autonomous Reg
Nanning, Guangxi, 530021, China
Henan province Cancer Hospital
Zhengzhou, Henan, 450008, China
The Second Xiangya Hospital of Central South Univer
Changsha, Hunan, 410011, China
The First People Hospital of Yueyang
Yueyang, Hunan, 414000, China
Nanjing General Hospital
Nanjing, Jiangsu, 210002, China
The Affiliated Hospital Of Xuzhou Medical College
Xuzhou, Jiangsu, 221000, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221000, China
Northern Jiangsu People Hospital
Yangzhou, Jiangsu, 225000, China
Shandong Cancer Hospital
Jinan, Shandong, 250000, China
The Affiliated Hospital Of Qingdao University
Qingdao, Shandong, 266003, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Yunnan Provincial Cancer Hospital
Kunming, Yunnan, 650118, China
Sir run run shaw hospital School of Medicine
Hangzhou, Zhejiang, 310016, China
CRLCC - Paoli-Calmette
Marseille, BP, 156, France
Hopital de la Croix-Rousse
Lyon, Cedex 04, 69317, France
Centre hospitalier universitaire de Montpellier
Montpellier, Cedex 05, 34295, France
AP-HP Hopital Tenon
Paris, Cedex 20, 75970, France
Hopital Albert Michallon
Grenoble, Cedex 9, 38043, France
CHRU de Tours - Hopital Bretonneau
Tours, Tours Cedex 9, 37044, France
CHU - Angers
Angers, 49033, France
Centre Hospitalier - Avignon
Avignon, 84000, France
Institut Sainte Catherine
Avignon, 84000, France
Bayonne - Centre Hospitalier
Bayonne, 64100, France
Hopital Jean Minjoz
Besançon, 25030, France
Hopital Avicenne
Bobigny, CEDEX 93009, France
Polyclinique Bordeaux Nord
Bordeaux, 33077, France
Boulogne - Ambroise Pare
Boulogne, 92104, France
Caen - CHU
Caen, 14000, France
Centre Hospitalier de Chambery
Chambéry, 73000, France
Centre Hospitalier de Cholet
Cholet, 49325, France
HIA Percy
Clamart, 92141, France
Clermont-Ferrand - CHU
Clermont-Ferrand, 63003, France
Hopital Louis Pasteur
Colmar, 68024, France
Annemasse - Centre Hospitalier Alpes Leman
Contamine-sur-Arve, 74130, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100, France
Centre Hospitalier Intercommunal de Creteil
Créteil, 94000, France
CHU Hopital du Bocage
Dijon, 21079, France
Centre Hospitalier Intercommunal - Elbeuf
Elbeuf, 76503, France
Centre Hospitalier departemental
La Roche-sur-Yon, 85925, France
Versailles - CH Andre Mignot
Le Chesnay, 78157, France
Centre Hospitalier du Mans
Le Mans, 72037, France
Lille - Hopital Calmette
Lille, 59037, France
Centre Hospitalier Lyon Sud
Lyon, 69495, France
Hopital Europeen
Marseille, 13291, France
Marseille - Hopital Nord
Marseille, 13915, France
Centre Hospitalier les Chanaux
Mâcon, 71018, France
CH de la Region d'Annecy
Metz-Tessy, 74370, France
Centre Hospitalier de Mulhouse
Mulhouse, 68070, France
Centre Antoine Lacassagne - Nice
Nice, 06189, France
Centre Hospitalier Regional Hopital de la Source
Orléans, 45000, France
Hopital Saint Louis
Paris, 75010, France
Fondation Hopital Saint Joseph
Paris, 75014, France
Paris - HEGP
Paris, 75015, France
Paris - Institut Curie
Paris, 75248, France
Hopital Bichat
Paris, 75877, France
Centre Hospitalier General de Pau
Pau, 64000, France
Centre Hospitalier de Perigueux
Périgueux, 24019, France
Centre Hospitalier Rene Dubos
Pontoise, 95301, France
CHU de Rouen
Rouen, 76031, France
Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez, 42271, France
Centre Hospitalier de Saint-Quentin
Saint-Quentin, 02100, France
Nouvel Hopital Civil Hopitaux
Strasbourg, 67091, France
Suresnes - Foch
Suresnes, 92151, France
Thonon-les-Bains - Hopital Georges Pianta
Thonon-les-Bains, 74203, France
CHITS Toulon Sainte Musse
Toulon, 83056, France
Hopital Larrey
Toulouse, 31059, France
Villefranche sur Saone - CH
Villefranche-sur-Saône, 69655, France
Semmelweis University Pulmonology Department
Budapest, 1125, Hungary
AOU Ospedali Riuniti Umberto I
Torrette, AN, 60126, Italy
Azienda Ospedaliera San Giuseppe Moscati
Avellino, AV, 83100, Italy
IRCCS Ospedale Oncologico Giovanni Paolo II
Bari, BA, 70124, Italy
Instituto Clinico Humanitas
Rozzano (MI), Lombardy, 20089, Italy
Ospedale S. Paolo - U.O. di Oncologia Medica
Milan, MI, 20142, Italy
Azienda Ospedaliera di Perugia Santa Maria
Perugia, PG, 06129, Italy
Centro di Riferimento Oncologico - CRO
Aviano, PN, 33081, Italy
Fondazione Salvatore Maugeri Oncologia Medica
Pavia, PV, 27100, Italy
OUC Oncologia Medica - Presidio Ospedaliero
Ravenna, RA, 48121, Italy
Oncologia Medica IRCCS Arcispedale Maria
Reggio Emilia, RE, 42123, Italy
Istituti Fisioterapici Ospitalieri IFO Istituto
Rome, RM, 00144, Italy
A.O. Busto Arsizio - P.O. Saronno
Saronno, VA, 21047, Italy
AOU Integrata Verona Policlinico GB
Verona, VR, 37134, Italy
U.O. di Oncologia Medica Azienda Ospedaliera G Rummo
Benevento, 82100, Italy
PO A Perrino ASL Brindisi - UOC Oncologia Medica
Brindisi, 72100, Italy
AOU Policlinico Vittorio Emanuele UOC di Oncologia
Catania, 95125, Italy
U.O. di Oncologia Ospedale Villa Scassi
Genova, 16149, Italy
Intstituto Scientifico Romangnolo
Meldola, 47014, Italy
European Institute of Oncology
Milan, 20141, Italy
U.O.C. di Oncologia U.L.S.S. 13
Mirano, 30035, Italy
Azienda Ospedaliera di Rilievo Nazionale
Napoli, 80131, Italy
Dott. Fortunato Ciardiello,Cattedra Oncologia Medica
Napoli, 80131, Italy
Unita Sperimentazioni Cliniche Istituto per lo
Napoli, 80131, Italy
Universita Federico II UOC Oncologia Medica
Napoli, 80131, Italy
UOC Oncologia Medica II Instituto Oncologio Veneto
Padua, 35128, Italy
Azienda USL di Piacenza, Ospedale Gugliemimo Salieto
Piacenza, 29100, Italy
Azienda Ospedaliera S. Camillo-Forlanin
Rome, 00152, Italy
Japanese Red Cross Nagoya Daiichi Hospital
Nagoya, Aichi-ken, 453-8511, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Hospital of the University of Occupational and
Kitakyushu, Fukuoka, 807-8556, Japan
Gifu Univiesity Hospital
Gifu, Gifu, 501-1194, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
National Hospital Organization Kure Medical Center
Kure, Hiroshima, 737-0023, Japan
Koube University Hospital
Kobe, Hyōgo, 650-0017, Japan
Hyogo College of Medicine
Nishinomiya-shi, Hyōgo, 663-8501, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Kinki University Hospital Faculty of Medicine
Ōsaka-sayama, Osaka, 589-8511, Japan
National Hospital Organization Kinki-Chuo
Sakai, Osaka, 591-8555, Japan
Tottori University Hospital
Yonago, Tottori, 683-8504, Japan
National Hospital Organization Yamaguchi
Ube, Yamaguchi, 755-0241, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Osaka International Cancer Institute
Osaka, 537-8511, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
Tokyo Medical University Hospital
Tokyo, 160-0023, Japan
Kanagawa Cancer Center
Yokohama, 241-0815, Japan
Universitair medisch centrum Nijmegen st Radboud
Nijmegen, Gelderland, 6525 GA, Netherlands
Amphia ziekenhuis
Breda, North Brabant, 4818 CK BREDA, Netherlands
Tergooi locatie Hilversum
Hilversum, North Holland, 1213XZ, Netherlands
Isala
Zwolle, Overijssel, 8025 AB, Netherlands
Netherlands Cancer Institute
Amsterdam, 1066 CX, Netherlands
Free University Hospital
Amsterdam, Netherlands
UMC Groningen
Groningen, 9713 GZ, Netherlands
Academical Hospital Maastricht
Maastricht, 622G HX, Netherlands
Erasmus Medical Center (EMC)
Rotterdam, Netherlands
Christchurch Hospital
Christchurch, New Zealand
Klinika Onkologii i Radioterapii Uniwersyteckie
Gdansk, 80-214, Poland
Specjalistyczny Szpital im
Szczecin, 70 891, Poland
Samodzielny Publiczny Szpital Specjalistyczny
Zakopane, 34 500, Poland
Conformal Med Terra HIFU
Bucharest, 031864, Romania
Spitalul de Psihiatrie Dr. Constantin Gorgos
Bucharest, 30447, Romania
Oncology Institute Bucharest
Bucharest, Romania
Oncological Institute "Ion Chiricuta"
Cluj-Napoca, 3400, Romania
OCH - Ovidius Clinical Hospital
Constanța, 905900, Romania
Centrul de Oncologie Sf Nectarie
Craiova, 200347, Romania
SC Oncolab SRL
Craiova, 200385, Romania
Spital Lotus SRL
Ploieşti, 100011, Romania
National University Hospital
Singapore, 119074, Singapore
Keimyung University Dongsan Medical Center
Daegu, Dalseogu, 42601, South Korea
Chung Ang University Hospital
Seoul, Dongjak Gu, 156-755, South Korea
Veterans Health Service Medical Center
Seoul, Gangdong-gu, 134-791, South Korea
The Catholic University of Korea Bucheon
Bucheon-si, Gyeonggi-do, 420-717, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 443-380, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 362-711, South Korea
Uijeongbu ST Marys Hospital
Gyeonggi-do, 11765, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
The Catholic University of Korea,
Seoul, 137-701, South Korea
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital Insular de Gran Canaria
Las Palmas, Gran Canaria, 35016, Spain
Hospital Teresa Herrera
A Coruña, 15006, Spain
Hospital General de Alicante
Alicante, 03010, Spain
Hoapital Quiron Dexeus
Barcelona, 08028, Spain
Hospital Vall d Hebron
Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Duran i Reynals
Barcelona, 08907, Spain
Complejo Asistencial Universitario de Leon
León, 24071, Spain
Hospital Universitario la Princesa
Madrid, 28006, Spain
Hospital Puerta de Hierro
Madrid, 28035, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Son Llatzer
Palma de Mallorca, 07198, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Far Eastern Memorial Hospital
New Taipei City;, Taiwan, 220, Taiwan
Chang-Gung Memorial Hospital - Chiayi
Chiayi City, 613, Taiwan
Kaohsiung Medical University
Kaohsiung City, 807, Taiwan
E-Da Hospital
Kaohsiung City, 82445, Taiwan
Chang-Gung Memorial Hospital - Kaohsiung
Kaohsiung City, 833, Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 235, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Mackay Memorial Hospital
Taipei, 104, Taiwan
Veterans General Hospital - Taipei
Taipei, 112, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Chang-Gung Memorial Hospital - Linkou
Taoyuan District, 333, Taiwan
Dnipropetrovsk City Clinical Hospital No.4
Dnipropetrovsk, 49102, Ukraine
Regional Oncology Center
Sumy, 40004, Ukraine
Vinnytsia Regional Clinical Oncology Dispensary
Vinnitsia, 21029, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Glenwood Goss
Ottawa Hospital Research Institute, Ontario, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2014
First Posted
October 24, 2014
Study Start
February 24, 2015
Primary Completion
July 23, 2025
Study Completion
January 31, 2026
Last Updated
August 12, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share