search
Back to results

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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MEDI4736
Placebo
Sponsored by
Canadian Cancer Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banner MD Anderson Cancer Center
  • USC Norris/Comprehensive Cancer Centre
  • National Jewish Health
  • University of Florida
  • H. Lee Moffitt Cancer Center
  • Duke University Medical Center
  • Hematology and Oncology Associates of NEPA
  • Thomas Jefferson University
  • The Reading Hospital Medical Center
  • Campbelltown Hospital
  • Chris O'Brien Lifehouse
  • Coffs Habour Health Campus - NCCI
  • Gosford Hospital
  • Nepean Hospital
  • St. George Hospital, Cancer Care Centre
  • Liverpool Cancer Therapy Centre, Liverpool Hospital
  • Northern Cancer Institute St Leonards
  • Westmead Hospital
  • Sunshine Coast University Hospital
  • Princess Alexandra Hospital
  • The Prince Charles Hospital
  • Royal Adelaide Hospital
  • Mater Medical Centre
  • Royal Hobart Hospital
  • Monash Medical Centre
  • Frankston Hospital - Peninsula Oncology Centre
  • Austin Hospital
  • Royal Melbourne Hospital Research Foundation
  • Epworth HealthCare - Richmond
  • Border Medical Oncology
  • Fiona Stanley Hospital
  • Sir Charles Gairdner Hospital
  • St John of God Subiaco
  • Flinders Medical Center
  • Canberra Hospital
  • St. Vincent's Hospital
  • Suporte Nutricional e Quimioterapia LTDA PRONUTRIR
  • Hospital Evangelico de Cachoeiro de Itapemirim
  • Cetus Hospital Dia Oncologia
  • Liga Norte Riograndense Contra o Cancer
  • Instituto Tacchini de Pesquisa em Saude
  • Centro de Oncologia e Radioterapia (COR) Mae de Deus
  • Clinica de Neoplasias Litoral
  • Faculdade de Medicina do ABC
  • Fundacao Faculdade Regional de Medicina
  • Instituto Nacional de Cancer (INCA)
  • MHAT Serdika - Medical Oncology Clinic
  • MHAT Nadezhda Hospital
  • Medical Centre Synexus
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • BCCA - Abbotsford Centre
  • BCCA - Fraser Valley Cancer Centre
  • BCCA - Vancouver Cancer Centre
  • CancerCare Manitoba
  • The Moncton Hospital
  • Regional Health Authority B, Zone 2
  • Dr. H. Bliss Murphy Cancer Centre
  • QEII Health Sciences Centre
  • Juravinski Cancer Centre at Hamilton Health Sciences
  • Kingston Health Sciences Centre
  • London Regional Cancer Program
  • Stronach Regional Health Centre at Southlake
  • Lakeridge Health Oshawa
  • Ottawa Hospital Research Institute
  • Algoma District Cancer Program
  • Niagara Health System
  • Health Sciences North
  • Thunder Bay Regional Health Sciences Centre/Thunder
  • Humber River Hospital
  • Odette Cancer Centre
  • Sinai Health System
  • University Health Network
  • PEI Cancer Treatment Centre
  • CHUM-Centre Hospitalier de l'Universite de Montreal
  • The Jewish General Hospital
  • The Research Institute of the McGill University
  • Centre Integre Universitaire De Sante Et De Services
  • University Institute of Cardiology and
  • Allan Blair Cancer Centre
  • Saskatoon Cancer Centre
  • Beijing Cancer Hospital
  • Fujian Province Cancer Hospital
  • Guangdong General Hospital
  • The Second Affiliated Hosp of Shantou Medical Colleg
  • The People Hospital of Guangxi Zhuang Autonomous Reg
  • Henan province Cancer Hospital
  • The Second Xiangya Hospital of Central South Univer
  • The First People Hospital of Yueyang
  • Nanjing General Hospital
  • The Affiliated Hospital Of Xuzhou Medical College
  • Xuzhou Central Hospital
  • Northern Jiangsu People Hospital
  • Shandong Cancer Hospital
  • The Affiliated Hospital Of Qingdao University
  • Zhongshan Hospital Fudan University
  • Yunnan Provincial Cancer Hospital
  • Sir run run shaw hospital School of Medicine
  • CRLCC - Paoli-Calmette
  • Hopital de la Croix-Rousse
  • Centre hospitalier universitaire de Montpellier
  • AP-HP Hopital Tenon
  • Hopital Albert Michallon
  • CHRU de Tours - Hopital Bretonneau
  • CHU - Angers
  • Centre Hospitalier - Avignon
  • Institut Sainte Catherine
  • Bayonne - Centre Hospitalier
  • Hopital Jean Minjoz
  • Hopital Avicenne
  • Polyclinique Bordeaux Nord
  • Boulogne - Ambroise Pare
  • Caen - CHU
  • Centre Hospitalier de Chambery
  • Centre Hospitalier de Cholet
  • HIA Percy
  • Clermont-Ferrand - CHU
  • Hopital Louis Pasteur
  • Annemasse - Centre Hospitalier Alpes Leman
  • Centre Hospitalier Sud Francilien
  • Centre Hospitalier Intercommunal de Creteil
  • CHU Hopital du Bocage
  • Centre Hospitalier Intercommunal - Elbeuf
  • Centre Hospitalier departemental
  • Versailles - CH Andre Mignot
  • Centre Hospitalier du Mans
  • Lille - Hopital Calmette
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier les Chanaux
  • Hopital Europeen
  • Marseille - Hopital Nord
  • CH de la Region d'Annecy
  • Centre Hospitalier de Mulhouse
  • Centre Antoine Lacassagne - Nice
  • Centre Hospitalier Regional Hopital de la Source
  • Paris - Institut Curie
  • Hopital Saint Louis
  • Fondation Hopital Saint Joseph
  • Paris - HEGP
  • Hopital Bichat
  • Centre Hospitalier General de Pau
  • Centre Hospitalier de Perigueux
  • Centre Hospitalier Rene Dubos
  • CHU de Rouen
  • Institut de Cancerologie de la Loire
  • Centre Hospitalier de Saint-Quentin
  • Nouvel Hopital Civil Hopitaux
  • Suresnes - Foch
  • Thonon-les-Bains - Hopital Georges Pianta
  • CHITS Toulon Sainte Musse
  • Hopital Larrey
  • Villefranche sur Saone - CH
  • Semmelweis University Pulmonology Department
  • AOU Ospedali Riuniti Umberto I
  • Azienda Ospedaliera San Giuseppe Moscati
  • IRCCS Ospedale Oncologico Giovanni Paolo II
  • Instituto Clinico Humanitas
  • Ospedale S. Paolo - U.O. di Oncologia Medica
  • Azienda Ospedaliera di Perugia Santa Maria
  • Centro di Riferimento Oncologico - CRO
  • Fondazione Salvatore Maugeri Oncologia Medica
  • OUC Oncologia Medica - Presidio Ospedaliero
  • Oncologia Medica IRCCS Arcispedale Maria
  • Istituti Fisioterapici Ospitalieri IFO Istituto
  • A.O. Busto Arsizio - P.O. Saronno
  • AOU Integrata Verona Policlinico GB
  • U.O. di Oncologia Medica Azienda Ospedaliera G Rummo
  • PO A Perrino ASL Brindisi - UOC Oncologia Medica
  • AOU Policlinico Vittorio Emanuele UOC di Oncologia
  • U.O. di Oncologia Ospedale Villa Scassi
  • Intstituto Scientifico Romangnolo
  • European Institute of Oncology
  • U.O.C. di Oncologia U.L.S.S. 13
  • Azienda Ospedaliera di Rilievo Nazionale
  • Dott. Fortunato Ciardiello,Cattedra Oncologia Medica
  • Unita Sperimentazioni Cliniche Istituto per lo
  • Universita Federico II UOC Oncologia Medica
  • UOC Oncologia Medica II Instituto Oncologio Veneto
  • Azienda USL di Piacenza, Ospedale Gugliemimo Salieto
  • Azienda Ospedaliera S. Camillo-Forlanin
  • Japanese Red Cross Nagoya Daiichi Hospital
  • Nagoya University Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • Hospital of the University of Occupational and
  • Gifu Univiesity Hospital
  • Gunma University Hospital
  • National Hospital Organization Kure Medical Center
  • Koube University Hospital
  • Hyogo College of Medicine
  • Kanazawa University Hospital
  • Sendai Kousei Hospital
  • Kurashiki Central Hospital
  • Kansai Medical University Hospital
  • Kinki University Hospital Faculty of Medicine
  • National Hospital Organization Kinki-Chuo
  • Tottori University Hospital
  • National Hospital Organization Yamaguchi
  • Chiba University Hospital
  • National Hospital Organization Kyushu Medical Center
  • Kyushu University Hospital
  • Hiroshima City Hiroshima Citizens Hospital
  • Hiroshima University Hospital
  • Osaka City General Hospital
  • Osaka International Cancer Institute
  • Juntendo University Hospital
  • Tokyo Medical University Hospital
  • Kanagawa Cancer Center
  • Chungbuk National University Hospital
  • Keimyung University Dongsan Medical Center
  • Chung Ang University Hospital
  • Veterans Health Service Medical Center
  • The Catholic University of Korea Bucheon
  • Ajou University Hospital
  • Uijeongbu ST Marys Hospital
  • Kangbuk Samsung Hospital
  • The Catholic University of Korea,
  • Universitair medisch centrum Nijmegen st Radboud
  • Amphia ziekenhuis
  • Tergooi locatie Hilversum
  • Isala
  • Netherlands Cancer Institute
  • Free University Hospital
  • UMC Groningen
  • Academical Hospital Maastricht
  • Erasmus Medical Center (EMC)
  • Christchurch Hospital
  • Klinika Onkologii i Radioterapii Uniwersyteckie
  • Specjalistyczny Szpital im
  • Samodzielny Publiczny Szpital Specjalistyczny
  • Conformal Med Terra HIFU
  • Spitalul de Psihiatrie Dr. Constantin Gorgos
  • Oncology Institute Bucharest
  • Oncological Institute "Ion Chiricuta"
  • OCH - Ovidius Clinical Hospital
  • Centrul de Oncologie Sf Nectarie
  • SC Oncolab SRL
  • Spital Lotus SRL
  • National University Hospital
  • Hospital Germans Trias i Pujol
  • Hospital Mutua de Terrassa
  • Hospital Insular de Gran Canaria
  • Hospital General de Alicante
  • Hoapital Quiron Dexeus
  • Hospital Vall d Hebron
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Duran i Reynals
  • Hospital Teresa Herrera
  • Complejo Asistencial Universitario de Leon
  • Hospital Universitario la Princesa
  • Hospital Puerta de Hierro
  • Fundacion Jimenez Diaz
  • Hospital Clinico San Carlos
  • Hospital Son Llatzer
  • Hospital Universitario de Salamanca
  • Hospital General Universitario de Valencia
  • Far Eastern Memorial Hospital
  • Chang-Gung Memorial Hospital - Chiayi
  • E-Da Hospital
  • Kaohsiung Medical University
  • Chang-Gung Memorial Hospital - Kaohsiung
  • Taipei Medical University - Shuang Ho Hospital
  • China Medical University Hospital
  • Mackay Memorial Hospital
  • Veterans General Hospital - Taipei
  • Tri-Service General Hospital
  • Chang-Gung Memorial Hospital - Linkou
  • Dnipropetrovsk City Clinical Hospital No.4
  • Regional Oncology Center
  • Vinnytsia Regional Clinical Oncology Dispensary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MEDI4736

Placebo

Arm Description

MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier.

PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Compare overall survival (OS) for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Compare Lung cancer specific survival for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
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
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.
Determine survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile
Determine the incremental cost effectiveness and cost utility ratios for MEDI4736
Evaluate the predictive/prognostic significance of PD-L1 expression
Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event
Explore polymorphisms that may be associated with outcomes

Full Information

First Posted
October 22, 2014
Last Updated
August 3, 2023
Sponsor
Canadian Cancer Trials Group
Collaborators
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
search

1. Study Identification

Unique Protocol Identification Number
NCT02273375
Brief Title
Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC
Official Title
A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 24, 2015 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Cancer Trials Group
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MEDI4736
Arm Type
Experimental
Arm Description
MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier
Intervention Type
Drug
Intervention Name(s)
MEDI4736
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Compare Disease free survival (DFS) for patients with NSCLC that is PD-L1 expression TC ≥ 25% and patients without common activating EGFR mutations or ALK gene rearrangements
Time Frame
6.7 years
Secondary Outcome Measure Information:
Title
Disease-free survival in the remaining 5 patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Description
(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)
Time Frame
8 years
Title
Compare overall survival (OS) for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Time Frame
8 years
Title
Compare Lung cancer specific survival for patients in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Time Frame
8 years
Title
Evaluate the nature, severity and frequency of adverse effects and tolerability of MEDI4736
Description
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
Time Frame
every 6 months
Title
Evaluate the Quality of life in the six patient sub-populations defined by PD-L1 expression levels and EGFR/ALK status
Description
The quality of life (QoL) of patients will be assessed using EORTC QLQ-C30 and the lung cancer module (QLQ-LC13) incorporated.
Time Frame
8 years
Title
Determine survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile
Time Frame
8 years
Title
Determine the incremental cost effectiveness and cost utility ratios for MEDI4736
Time Frame
8 years
Title
Evaluate the predictive/prognostic significance of PD-L1 expression
Time Frame
8 years
Title
Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event
Time Frame
8 years
Title
Explore polymorphisms that may be associated with outcomes
Time Frame
Baseline only

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs