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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02273375
• Other study ID #: BR31
• Secondary ID: IFCT1401ACTRN126
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 24, 2015
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2023
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1415
• Est. completion date: January 31, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung. according to WHO Classification of Tumours (WHO Classification of Tumours of the Lung, Pleura, Thymus and Heart. WHO/IARC Classification of Tumours, 4th Edition, Volume 7). Patients with large-cell neuroendocrine carcinomas are not eligible.
• Patients must be classified post-operatively as Stage IB (= 4cm in the longest diameter), II or IIIA on the basis of pathologic criteria. Note: Although T3N2M0 tumours have been reclassified to stage IIIB in the 8th edition of the IASLC staging system, these patients remain eligible (as stage IIIA under the 7th edition criteria).
• Complete surgical resection of the primary NSCLC is also mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour. Resection may be accomplished by open or VATS techniques Note: Patients with synchronous primary tumours will not be eligible due to the potential uncertainty regarding their appropriate PD-L1 status.

Prior Systemic Therapy:

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

Radiation:

• Patients with N2 disease only who receive adjuvant post-operative radiation therapy are eligible provided they meet the protocol specified timing criteria for surgery, adjuvant chemotherapy and randomization. Pre-operative radiation therapy is not permissible.
• The patient must have an ECOG performance status of 0, 1.
• Hematology: . Absolute neutrophil count = 1.5 x 109/L or = 1,500/µl Platelets = 100 x 109/L or = 100,000/µl
• Biochemistry:

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

• excluding Gilbert's syndrome Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula: Females: GFR = 1.04 x (140-age) x weight in kg serum creatinine in µmol/L Males: GFR = 1.23 x (140-age) x weight in kg serum creatinine in µmol/L
• Patient able and willing to complete the QoL, economics and other questionnaires. The baseline assessment must already have been completed within required timelines prior to randomization. Inability (illiteracy, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible
• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
• Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
• Protocol treatment is to begin within 2 working days of patient randomization

Exclusion Criteria:

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

This includes but is not limited to:

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• MEDI4736

• Placebo

Locations

Country	Name	City	State
Australia	Flinders Medical Center	Adelaide
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Sunshine Coast University Hospital	Birtinya	Queensland
Australia	Mater Medical Centre	Brisbane	South, QLD
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Campbelltown Hospital	Campbelltown	New South Wales
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Coffs Habour Health Campus - NCCI	Coffs Harbour	New South Wales
Australia	Frankston Hospital - Peninsula Oncology Centre	Frankston	Victoria
Australia	Canberra Hospital	Garran
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	St. George Hospital, Cancer Care Centre	Kogarah	New South Wales
Australia	Liverpool Cancer Therapy Centre, Liverpool Hospital	Liverpool	New South Wales
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Royal Melbourne Hospital Research Foundation	Parkville	Victoria
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia
Australia	Epworth HealthCare - Richmond	Richmond	Victoria
Australia	Northern Cancer Institute St Leonards	St Leonards	New South Wales
Australia	St John of God Subiaco	Subiaco	Western Australia
Australia	St. Vincent's Hospital	Victoria Park
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Border Medical Oncology	Wodonga	Victoria
Brazil	Cetus Hospital Dia Oncologia	Belo Horizonte	Minas Gerais
Brazil	Instituto Tacchini de Pesquisa em Saude	Bento Goncalves	Rio Grande Do Sul
Brazil	Hospital Evangelico de Cachoeiro de Itapemirim	Cachoeiro de Itapemirim	Espirito Santo
Brazil	Suporte Nutricional e Quimioterapia LTDA PRONUTRIR	Fortaleza	Ceara
Brazil	Clinica de Neoplasias Litoral	Itajai	Santa Catarina
Brazil	Liga Norte Riograndense Contra o Cancer	Natal	Rio Grande Do Norte
Brazil	Centro de Oncologia e Radioterapia (COR) Mae de Deus	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto Nacional de Cancer (INCA)	Rio de Janeiro
Brazil	Fundacao Faculdade Regional de Medicina	Sao Jose do Rio Preto	Sao Paulo
Brazil	Faculdade de Medicina do ABC	Sao Paulo	Santo Andre
Bulgaria	Medical Centre Synexus	Sofia
Bulgaria	MHAT Nadezhda Hospital	Sofia
Bulgaria	MHAT Serdika - Medical Oncology Clinic	Sofia
Canada	BCCA - Abbotsford Centre	Abbotsford	British Columbia
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	PEI Cancer Treatment Centre	Charlottetown	Prince Edward Island
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	London Regional Cancer Program	London	Ontario
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	Centre Integre Universitaire De Sante Et De Services	Montreal	Quebec
Canada	CHUM-Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	The Jewish General Hospital	Montreal	Quebec
Canada	The Research Institute of the McGill University	Montreal	Quebec
Canada	Stronach Regional Health Centre at Southlake	Newmarket	Ontario
Canada	Lakeridge Health Oshawa	Oshawa	Ontario
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	University Institute of Cardiology and	Quebec City	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Regional Health Authority B, Zone 2	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Algoma District Cancer Program	Sault Ste. Marie	Ontario
Canada	Niagara Health System	St. Catharines	Ontario
Canada	Dr. H. Bliss Murphy Cancer Centre	St. John's	Newfoundland and Labrador
Canada	Health Sciences North	Sudbury	Ontario
Canada	BCCA - Fraser Valley Cancer Centre	Surrey	British Columbia
Canada	Thunder Bay Regional Health Sciences Centre/Thunder	Thunder Bay	Ontario
Canada	Humber River Hospital	Toronto	Ontario
Canada	Odette Cancer Centre	Toronto	Ontario
Canada	Sinai Health System	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	BCCA - Vancouver Cancer Centre	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba
China	Beijing Cancer Hospital	Beijing	Beijing
China	The Second Xiangya Hospital of Central South Univer	Changsha	Hunan
China	Fujian Province Cancer Hospital	Fuzhou	Fujian
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Sir run run shaw hospital School of Medicine	Hangzhou	Zhejiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	Yunnan Provincial Cancer Hospital	Kunming	Yunnan
China	Nanjing General Hospital	Nanjing	Jiangsu
China	The People Hospital of Guangxi Zhuang Autonomous Reg	Nanning	Guangxi
China	The Affiliated Hospital Of Qingdao University	Qingdao	Shandong
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	The Second Affiliated Hosp of Shantou Medical Colleg	Shantou	Guangdong
China	The Affiliated Hospital Of Xuzhou Medical College	Xuzhou	Jiangsu
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	Northern Jiangsu People Hospital	Yangzhou	Jiangsu
China	The First People Hospital of Yueyang	Yueyang	Hunan
China	Henan province Cancer Hospital	Zhengzhou	Henan
France	CHU - Angers	Angers
France	Centre Hospitalier - Avignon	Avignon
France	Institut Sainte Catherine	Avignon
France	Bayonne - Centre Hospitalier	Bayonne
France	Hopital Jean Minjoz	Besancon Cedex
France	Hopital Avicenne	Bobigny
France	Polyclinique Bordeaux Nord	Bordeaux
France	Boulogne - Ambroise Pare	Boulogne
France	Caen - CHU	Caen
France	Centre Hospitalier de Chambery	Chambery
France	Centre Hospitalier de Cholet	Cholet
France	HIA Percy	Clamart
France	Clermont-Ferrand - CHU	Clermont-Ferrand
France	Hopital Louis Pasteur	Colmar
France	Annemasse - Centre Hospitalier Alpes Leman	Contamine Sur Arve
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes
France	Centre Hospitalier Intercommunal de Creteil	Creteil
France	CHU Hopital du Bocage	Dijon
France	Centre Hospitalier Intercommunal - Elbeuf	Elbeuf
France	Hopital Albert Michallon	Grenoble	Cedex 9
France	Centre Hospitalier departemental	La Roche Sur Yon
France	Versailles - CH Andre Mignot	Le Chesnay
France	Centre Hospitalier du Mans	Le Mans
France	Lille - Hopital Calmette	Lille
France	Centre Hospitalier Lyon Sud	Lyon
France	Hopital de la Croix-Rousse	Lyon	Cedex 04
France	Centre Hospitalier les Chanaux	Macon
France	Hopital Europeen	Marseille
France	Marseille - Hopital Nord	Marseille
France	CRLCC - Paoli-Calmette	Marseille Cedex	BP
France	CH de la Region d'Annecy	Metz-Tessy
France	Centre hospitalier universitaire de Montpellier	Montpellier	Cedex 05
France	Centre Hospitalier de Mulhouse	Mulhouse
France	Centre Antoine Lacassagne - Nice	Nice
France	Centre Hospitalier Regional Hopital de la Source	Orleans
France	AP-HP Hopital Tenon	Paris	Cedex 20
France	Fondation Hopital Saint Joseph	Paris
France	Hopital Bichat	Paris
France	Hopital Saint Louis	Paris
France	Paris - HEGP	Paris
France	Paris - Institut Curie	Paris Cedex 5
France	Centre Hospitalier General de Pau	Pau
France	Centre Hospitalier de Perigueux	Perigueux
France	Centre Hospitalier Rene Dubos	Pontoise
France	CHU de Rouen	Rouen
France	Institut de Cancerologie de la Loire	Saint-priest-en-jarez
France	Centre Hospitalier de Saint-Quentin	Saint-Quentin
France	Nouvel Hopital Civil Hopitaux	Strasbourg
France	Suresnes - Foch	Suresnes
France	Thonon-les-Bains - Hopital Georges Pianta	Thonon Les Bains
France	CHITS Toulon Sainte Musse	Toulon
France	Hopital Larrey	Toulouse
France	CHRU de Tours - Hopital Bretonneau	Tours Cedex	Tours Cedex 9
France	Villefranche sur Saone - CH	Villefranche Sur Saone
Hungary	Semmelweis University Pulmonology Department	Budapest
Italy	Azienda Ospedaliera San Giuseppe Moscati	Avellino	AV
Italy	Centro di Riferimento Oncologico - CRO	Aviano	PN
Italy	IRCCS Ospedale Oncologico Giovanni Paolo II	Bari	BA
Italy	U.O. di Oncologia Medica Azienda Ospedaliera G Rummo	Benevento
Italy	PO A Perrino ASL Brindisi - UOC Oncologia Medica	Brindisi
Italy	AOU Policlinico Vittorio Emanuele UOC di Oncologia	Catania
Italy	U.O. di Oncologia Ospedale Villa Scassi	Genova
Italy	Intstituto Scientifico Romangnolo	Meldola
Italy	European Institute of Oncology	Milan
Italy	Ospedale S. Paolo - U.O. di Oncologia Medica	Milano	MI
Italy	U.O.C. di Oncologia U.L.S.S. 13	Mirano
Italy	Azienda Ospedaliera di Rilievo Nazionale	Napoli
Italy	Dott. Fortunato Ciardiello,Cattedra Oncologia Medica	Napoli
Italy	Unita Sperimentazioni Cliniche Istituto per lo	Napoli
Italy	Universita Federico II UOC Oncologia Medica	Napoli
Italy	UOC Oncologia Medica II Instituto Oncologio Veneto	Padova
Italy	Fondazione Salvatore Maugeri Oncologia Medica	Pavia	PV
Italy	Azienda Ospedaliera di Perugia Santa Maria	Perugia	PG
Italy	Azienda USL di Piacenza, Ospedale Gugliemimo Salieto	Piacenza
Italy	OUC Oncologia Medica - Presidio Ospedaliero	Ravenna	RA
Italy	Oncologia Medica IRCCS Arcispedale Maria	Reggio Emilia	RE
Italy	Azienda Ospedaliera S. Camillo-Forlanin	Rome
Italy	Istituti Fisioterapici Ospitalieri IFO Istituto	Rome	RM
Italy	Instituto Clinico Humanitas	Rozzano (MI)	Lombardia
Italy	A.O. Busto Arsizio - P.O. Saronno	Saronno	VA
Italy	AOU Ospedali Riuniti Umberto I	Torrette	AN
Italy	AOU Integrata Verona Policlinico GB	Verona	VR
Japan	Chiba University Hospital	Chiba
Japan	Kyushu University Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Gifu Univiesity Hospital	Gifu-shi	Gifu
Japan	Kansai Medical University Hospital	Hirakata	Osaka
Japan	Hiroshima City Hiroshima Citizens Hospital	Hiroshima
Japan	Hiroshima University Hospital	Hiroshima
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Hospital of the University of Occupational and	Kitakyushu	Fukuoka
Japan	Koube University Hospital	Kobe-shi	Hyogo
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	National Hospital Organization Kure Medical Center	Kure	Hiroshima
Japan	Gunma University Hospital	Maebashi-shi	Gunma
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama-shi	Ehime
Japan	Japanese Red Cross Nagoya Daiichi Hospital	Nagoya	Aichi
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Hyogo College of Medicine	Nishinomiya-shi	Hyogo
Japan	Osaka City General Hospital	Osaka
Japan	Osaka International Cancer Institute	Osaka
Japan	Kinki University Hospital Faculty of Medicine	Osaka-Sayama	Osaka
Japan	National Hospital Organization Kinki-Chuo	Sakai	Osaka
Japan	Sendai Kousei Hospital	Sendai	Miyagi
Japan	Juntendo University Hospital	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
Japan	National Hospital Organization Yamaguchi	Ube	Yamaguchi
Japan	Kanagawa Cancer Center	Yokohama City
Japan	Tottori University Hospital	Yonago	Tottori
Korea, Republic of	The Catholic University of Korea Bucheon	Bucheon	Gyeonggi Do
Korea, Republic of	Chungbuk National University Hospital	Cheongju	Chungcheongbuk Do
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu	Dalseogu
Korea, Republic of	Uijeongbu ST Marys Hospital	Gyeonggi-do
Korea, Republic of	Chung Ang University Hospital	Seoul	Dongjak Gu
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	The Catholic University of Korea,	Seoul
Korea, Republic of	Veterans Health Service Medical Center	Seoul	Gangdong-gu
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi Do
Netherlands	Free University Hospital	Amsterdam
Netherlands	Netherlands Cancer Institute	Amsterdam
Netherlands	Amphia ziekenhuis	Breda	Noord Brabant
Netherlands	UMC Groningen	Groningen
Netherlands	Tergooi locatie Hilversum	Hilversum	Noord Holland
Netherlands	Academical Hospital Maastricht	Maastricht
Netherlands	Universitair medisch centrum Nijmegen st Radboud	Nijmegen	Gelderland
Netherlands	Erasmus Medical Center (EMC)	Rotterdam
Netherlands	Isala	Zwolle	Overijssel
New Zealand	Christchurch Hospital	Christchurch
Poland	Klinika Onkologii i Radioterapii Uniwersyteckie	Gdansk
Poland	Specjalistyczny Szpital im	Szczecin
Poland	Samodzielny Publiczny Szpital Specjalistyczny	Zakopane
Romania	Conformal Med Terra HIFU	Bucharest
Romania	Oncology Institute Bucharest	Bucharest
Romania	Spitalul de Psihiatrie Dr. Constantin Gorgos	Bucharest
Romania	Oncological Institute "Ion Chiricuta"	Cluj-Napoca
Romania	OCH - Ovidius Clinical Hospital	Constanta
Romania	Centrul de Oncologie Sf Nectarie	Craiova
Romania	SC Oncolab SRL	Craiova
Romania	Spital Lotus SRL	Ploiesti
Singapore	National University Hospital	Singapore
Spain	Hospital General de Alicante	Alicante
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hoapital Quiron Dexeus	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Duran i Reynals	Barcelona
Spain	Hospital Vall d Hebron	Barcelona
Spain	Hospital Teresa Herrera	Coruna
Spain	Hospital Insular de Gran Canaria	Las Palmas	Gran Canaria
Spain	Complejo Asistencial Universitario de Leon	Leon
Spain	Fundacion Jimenez Diaz	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Universitario la Princesa	Madrid
Spain	Hospital Son Llatzer	Palma de Mallorca
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital General Universitario de Valencia	Valencia
Taiwan	Chang-Gung Memorial Hospital - Chiayi	Chiayi City
Taiwan	Chang-Gung Memorial Hospital - Kaohsiung	Kaohsiung
Taiwan	Kaohsiung Medical University	Kaohsiung
Taiwan	E-Da Hospital	Kaohsiung City
Taiwan	Taipei Medical University - Shuang Ho Hospital	New Taipei City
Taiwan	Far Eastern Memorial Hospital	New Taipei City;	Taiwan;
Taiwan	China Medical University Hospital	Taichung
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Veterans General Hospital - Taipei	Taipei
Taiwan	Chang-Gung Memorial Hospital - Linkou	Taoyuan
Ukraine	Dnipropetrovsk City Clinical Hospital No.4	Dnipropetrovsk
Ukraine	Regional Oncology Center	Sumy
Ukraine	Vinnytsia Regional Clinical Oncology Dispensary	Vinnitsia
United States	National Jewish Health	Denver	Colorado
United States	Hematology and Oncology Associates of NEPA	Dunmore	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	USC Norris/Comprehensive Cancer Centre	Los Angeles	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	The Reading Hospital Medical Center	West Reading	Pennsylvania

Sponsors (11)

Lead Sponsor

Collaborator

Canadian Cancer Trials Group

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

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Bulgaria,  Canada,  China,  France,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Romania,  Singapore,  Spain,  Taiwan,  Ukraine, 

Outcome

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