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

Sponsor
Canadian Cancer Trials Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02273375
Collaborator
Intergroupe Francophone de Cancerologie Thoracique (Other), Australasian Lung Cancer Trials Group (Other), National Health and Medical Research Council, Australia (Other), National Cancer Institute (NCI), Naples (Other), Central and Eastern European Oncology Group (Other), Dutch Society of Physicians for Pulmonology and Tuberculosis (Other), Korean Cancer Study Group (Other), Fundación GECP (Other), West Japan Oncology Group (WJOG) (Other), Chinese Thoracic Oncology Group (Other)
1,415
Enrollment
271
Locations
2
Arms
111.7
Anticipated Duration (Months)
5.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1415 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer
Actual Study Start Date :
Oct 9, 2014
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

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.

Drug: MEDI4736
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

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Disease-free survival in the remaining 5 patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status [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)

  2. Compare overall survival (OS) for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status [8 years]

  3. 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]

  4. Evaluate the nature, severity and frequency of adverse effects and tolerability of MEDI4736 [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

  5. Evaluate the Quality of life in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status [8 years]

    The quality of life (QoL) of patients will be assessed using EORTC QLQ-C30 and the lung cancer module (QLQ-LC13) incorporated.

  6. Determine survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile [8 years]

  7. Determine the incremental cost effectiveness and cost utility ratios for MEDI4736 [8 years]

  8. Evaluate the predictive/prognostic significance of PD-L1 expression [8 years]

  9. Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event [8 years]

  10. Explore polymorphisms that may be associated with outcomes [Baseline only]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 RA;

  • 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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Canadian Cancer Trials Group
  • Intergroupe Francophone de Cancerologie Thoracique
  • Australasian Lung Cancer Trials Group
  • National Health and Medical Research Council, Australia
  • National Cancer Institute (NCI), Naples
  • Central and Eastern European Oncology Group
  • Dutch Society of Physicians for Pulmonology and Tuberculosis
  • Korean Cancer Study Group
  • Fundación GECP
  • West Japan Oncology Group (WJOG)
  • Chinese Thoracic Oncology Group

Investigators

  • Study Chair: Glenwood Goss, Ottawa Hospital Research Institute, Ontario, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Canadian Cancer Trials Group
ClinicalTrials.gov Identifier:
NCT02273375
Other Study ID Numbers:
  • BR31
  • IFCT1401
  • ACTRN12615000323527
  • U1111-1238-5923
First Posted:
Oct 24, 2014
Last Update Posted:
Mar 3, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Durvalumab

Study Results

No Results Posted as of Mar 3, 2022