EORTC-1416-LCG

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A randomized, phase 3 trial with anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 10-Nov-2015 Date Step1 close: 20-May-2020 Date Step2 close: 20-May-2020
Data management at EORTC	Yes
Design	Phase 3 Randomized blind
Targeted Sample size	All Groups: 1080
Treatment	Drug Pembrolizumab, Blind trial medication-1416
Study Staff	Mary O'Brien (Study Coordinator) , Royal Marsden Hospital - Sutton, Surrey, Surrey Herve Azobou (Statistical Analyst) , EORTC Headquarters, Brussels Katrien Baus (Admin. assistant DM) , EORTC Headquarters, Brussels Corneel Coens (Unblinded statistician) , EORTC Headquarters, Brussels Laura Decubber (Data Manager) , EORTC Headquarters, Brussels Catherine Fortpied (Unblinded statistician) , EORTC Headquarters, Brussels Beatrice Fournier (Unblinded Clinical Scientist) , EORTC Headquarters, Brussels Fanny Grillet (TR Scientist) , EORTC Headquarters, Brussels Nitish Jha (Statistical Analyst) , EORTC Headquarters, Brussels Belma Malanda (Project Manager) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Murielle Mauer (Statistician) , EORTC Headquarters, Brussels Ana Oliveira (Data Manager) , EORTC Headquarters, Brussels Pablo Oriol (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels Luis Paz-Ares (Study Co-Coordinator) , Hospital Universitario 12 De Octubre, Madrid Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Bette Stofs (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Cathy Van de Wiele (Data Manager) , EORTC Headquarters, Brussels Yuliya Vostrikova (Clinical Data Expert) , EORTC Headquarters, Brussels Gaetan de Schaetzen (Unblinded COM) , EORTC Headquarters, Brussels
Type of cancer	Lung
Participating groups	EORTC Lung Cancer Group ETOP IBCSG Partners Foundation
Recruiting centers	A Tsyb Medical Radiological Research Center (Obninsk, Russian Federation) A.O Landeskrankenhaus - Innsbruck Universitaetsklinik (Innsbruck, Austria) AUSL Della Romagna - Infermi Hospital -Rimini (Rimini, Italy) AUSL Della Romagna -Ospedale Santa Maria delle Croci (Ravenna, Italy) AZ Delta - Campus Rumbeke (Roeselare, Belgium) Aichi Cancer Center Hospital (Aichi, Japan) Alma Mater Studiorium Universita di Bologna - Loc. Ospedala Sant'Orsolo (Bologna, Italy) Altay Regional Clinical Oncology Dispensary (Barnaul, Russian Federation) Asan Medical Center (Seoul, Korea (Republic of)) Asklepios Fachkliniken Muenchen-Gauting (Gauting, Germany) Assaf Harofeh Medical Center (Zerifin, Israel) Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine (Udine, Italy) Azienda Ospedaliero-Universitaria di Parma (Parma, Italy) Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital (Romford Essex, United Kingdom) Burdenko Main Military Clinical Hospital (Moscow, Russian Federation) CHU - Clermont Ferrant - GabrielMontpied (CLERMONT FERRAND CEDEX 1, France) CHU Mont Godinne - UCL Namur (Yvoir, Belgium) CHU de Brest (Brest, France) CHU de Lyon - Hopital Louis Pradel (BRON, France) CHU de Rennes - Hôpital de Pontchaillou (RENNES CEDEX 9, France) Centralsygehuset i Naestved (Naestved, Denmark) Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (Bayonne, France) Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France) Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Centre Hospitalier Universitaire de Sherbrooke-Fleurimont (Sherbrooke, Canada) Centre integre de sante et de services sociaux de Laval-Hopital Charles Lemoyne (Greenfield Park, Quebec, Canada) Centro Hospitalar Universitario Lisboa Norte - Hospital Sta. Maria (Lisboa, Portugal) Centro Hospitalar do Porto-- Hospital de Santo Antonio (Porto, Portugal) Centro Hospitalar e Universitario de Coimbra - Hospital General (Coimbra, Portugal) Centro Pesquisas Oncologicas (Florianopolis, Brazil) Centro de Pesquisas Clinicas em Oncologia - Hospital Sao Lucas (Porto Alegre, Brazil) Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany) Clinica Peruano Americana S.A. (Trujillo, Peru) Cork University Hospital (Cork, Ireland) ETZ - St. Elisabethziekenhuis (Tilburg, Netherlands) East and North Hertfordshire NHS Trust – Mount Vernon Hospital (Northwood, United Kingdom) Ege University Medical Hospital (Bornova - Izmir, Turkey) Emek Medical Center (Afula, Israel) Evangelische Lungenklinik Berlin - Krankenhausbetriebs gGmbH (Berlin, Germany) Federal State Budgetary Institution, Russian oncology scientific centre named after N.N. Blokhin RAMS (Moscow, Russian Federation) Fukushima Medical University School Of Medicine (Fukushima, Japan) George Papanicolaou General Hospital (Thessaloniki, Greece) Grand Hopital de Charleroi - Site Notre Dame (Charleroi, Belgium) Gustave Roussy (VILLEJUIF CEDEX, France) Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom) Hadassah University Hospital- Ein Kerem (Jerusalem, Israel) Haemato-Onkologie Hamburg, Prof. Laack und Partner (Hamburg, Germany) Herlev Hospital - University Copenhagen (Herlev, Denmark) Hiroshima University Hospital (Hiroshima, Japan) Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland) Hosp. Clin Porto Alegre (Porto Alegre, Brazil) Hospital Bruno Born (Lajeado, Brazil) Hospital Clinic de Barcelona (Barcelona, Spain) Hospital Clinico Universitario Lozano Blesa (Zaragoza, Spain) Hospital Nacional "Arzobispo Loayza" (Lima, Peru) Hospital Nacional Carlos Alberto Seguin Escobedo - (HNCASE) Arequipa (Arequipa, Peru) Hospital Santa Izabel - Santa Casa de Misericordia da Bahia (Salvador, Brazil) Hospital Santa Marcelina (Sao Paulo, Brazil) Hospital Sao Vicente de Paulo (Passo Fundo, Brazil) Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain) Hospital Universitario 12 De Octubre (Madrid, Spain) Hospital Universitario Central De Asturias (Oviedo, Spain) Hospital Universitario La Paz (Madrid, Spain) Hospital Universitario Puerta De Hierro (Majadahonda, Spain) Hospital Universitario Ramon y Cajal (Madrid, Spain) Hospital Universitario Reina Sofia (Cordoba, Spain) Hospital Universitario Virgen De La Macarena (Sevilla, Spain) Hospital Universitario Virgen De La Victoria (Malaga, Spain) Hospital Universitario Virgen de Valme (Sevilla, Spain) Hospital Universitario Y Politecnico La Fe (Valencia, Spain) Hospital Unviersitario Miguel Servet (Zaragoza, Spain) Hospital de Amor (Barretos, Brazil) Hospitales HM San Chinarro-CIOCC (Madrid, Spain) Hyogo Cancer Center (Akashi-shi, Japan) IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy) IRCCS - Istituto Oncologico Veneto (Padova, Italy) IRCCS - Istituto Oncologico Veneto (Padova, Italy) IRCCS Ospedale San Martino (Genova, Italy) Illawarra Cancer Care Centre-Wollongong Hospital (Wollongong, Australia) Inselspital (Bern, Switzerland) Institut Jules Bordet (Anderlecht, Belgium) Instituto De Enfermedades Neoplasicas (Lima, Peru) Instituto Nacional Del Torax (Santiago (RM), Chile) Instituto Portugues de Oncologia de Lisboa Francisco Gentil – EPE (Lisboa, Portugal) Instituto Portugues de Oncologia do Porto Francisco Gentil (Porto, Portugal) Instituto do Cancer do Estado de Sao Paulo (Sao Paulo, Brazil) Istanbul Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi (Istanbul, Turkey) Kantonsspital Graubuenden (Chur, Switzerland) Kantonsspital St Gallen (St Gallen, Switzerland) Kantonsspital Winterthur (Winterthur, Switzerland) Keimyung University Dongsan Medical Center (Daegu, Korea (Republic of)) Kindai University Hospital (Osaka, Japan) Kitasato University Hospital (Kanagawa, Japan) Klinikum Esslingen GmBH (Esslingen, Germany) Koranyi National Institute For Pulmonology (Budapest, Hungary) Kurume University Hospital (Fukuoka, Japan) Kyorin University Hospital (Tokyo, Japan) Kyoto University Hospital (Kyoto-shi, Japan) Latvian Oncology Center (Riga, Latvia) Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom) Luzerner Kantonsspital (Luzern, Switzerland) Maidstone & Tunbridge Wells NHS Trust - Maidstone Hospital (Maidstone, United Kingdom) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) Mater Misericordia University Hospital (Dublin, Ireland) Matrahaza University and Teaching hospital (Herves, Hungary) Medical Oncology Sunshine Hospital Western Health (Saint Albans, Australia) Meir Hospital (Kfar Saba, Israel) Memorial Antalya Hastanesi (Antalya, Turkey) Memorial Antalya Hastanesi (Antalya, Turkey) NHS Grampian - Aberdeen Royal Infirmary (Aberdeen, United Kingdom) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) NHS Lothian - Western General Hospital (Edinburgh, United Kingdom) NHS Tayside - Ninewells Hospital (Dundee, Scotland, United Kingdom) National Cancer Center - Hospital East (Kashiwa-City, Chiba, Japan) National Cancer Center - Korea (Gyeonggi-do, Korea (Republic of)) National Institute Of Oncology (Budapest, Hungary) Nemocnice AGEL Ostrava-Vitkovice a.s. (Ostrava, Czech Republic) Niigata University Medical & Dental Hospital (Niigata-Shi, Japan) North Estonia Medical Centre - Mustamae unit (Tallinn, Estonia) Odense University Hospital (Odense C, Denmark) Oita University Hospital (Oita, Japan) Okayama University Hospital (Okayama, Japan) Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland) Ondokuz Mayis Universitesi Saglik Uygulama ve Arastirma Merkezi (Samsun, Turkey) Orenburg Regional Clinical Oncology Dispensary (Orenburg, Russian Federation) Ospedale San Gerardo Vecchio (Monza, Italy) Paula Stradins Clinical University Hospital (Riga, Latvia) Rabin Medical Center - Tel Aviv (Petah Tikva, Israel) Rambam Health Care Campus, Oncology Institute (Haifa, Israel) Regional Lung Diseases Center (Poznan, Poland) Regional Lung Diseases Hospital (Otwock, Poland) Republic Clinical Oncology Dispensary of Ministry of Health of Tatarstan Republic (Kazan, Russian Federation) Rijnstate Hospital (Arnhem, Netherlands) Rijnstate Hospital (Arnhem, Netherlands) Robert-Bosch Krankenhaus-Klinik Schillerhoehe (Gerlingen, Germany) Royal Marsden Hospital - Chelsea, London (London, United Kingdom) Royal Marsden Hospital - Sutton, Surrey (Surrey, United Kingdom) Royal Wolverhampton NHS - New Cross Hospital (Wolverhampton West Midlands, United Kingdom) Salzburger Landeskliniken - Universitätsklinikum Salzburg (Salzburg, Austria) Santa Croce e Carle General Hospital (Cuneo, Italy) Schwerpunktpraxis - Bonn (Bonn, Germany) Seirei Mikatahara General Hospital (Hamamatsu-shi, Japan) Seoul National University Bundang Hospital (Gyeonggi-do, Korea (Republic of)) Seoul National University Bundang Hospital (Gyeonggi-do, Korea (Republic of)) Seoul National University Hospital (Seoul, Korea (Republic of)) Severance Hospital, Yonsei University Health System ( YUCM) (Seoul, Korea (Republic of)) Sheba Medical Center Tel Hashomer (Ramat Gan, Israel) Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom) St. James'S Hospital (Dublin, Ireland) St. Marianna University School of Medicine Hospital (Kawasaki-Shi, Japan) State Healthcare Institution of Saint Petersburg, State clinical oncology dispensary (Saint Petersburg, Russian Federation) Tartu University Clinics (Tartu, Estonia) Tatabanyai Szent Borbala Korhaz (Tatabánya, Hungary) The Catholic University of Korea-St. Vincent's Hospital (Suwon-Si Gyeonggi-do, Korea (Republic of)) The Geelong Hospital - Andrew Love Cancer Centre (Geelong, Australia) The Institute Of Oncology (Ljubljana, Slovenia) The Tweed Hospital (Tweed Heads, Australia) Thomayerova nemocnice (Prague, Czech Republic) Thoracic General hospital of Athens I Sotiria (Athens, Greece) Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital (Tokyo, Japan) Trakya University Medical Faculty, Balkan Oncology Hospital (Edirne, Turkey) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Unidade Local de Saúde Gaia e Espinho (previously Cen.Hospitalar Vila Nova Gaia / Espinho) (Vila Nova De Gaia, Portugal) Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) UniversitaetsSpital Zurich (Zurich, Switzerland) Universitaetskliniken Des Saarlandes (Homburg / Saar, Germany) Universitaetsklinikum Schleswig-Holstein - Campus Luebeck (Luebeck, Germany) Universitaetsmedizin Goettingen - Georg-August Universitaet (Goettingen, Germany) Universitaetsspital Basel (Basel, Switzerland) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) University Clinic Golnik (Golnik, Slovenia) University General Hospital Heraklion (Heraklion, Greece) University Hospital Bulovka (Prague 8 Liben, Czech Republic) University Hospital Frankfurt- Goethe University (Frankfurt Am Main, Germany) University Hospital In Plzen (Plzen, Czech Republic) University Hospital Limerick (Limerick, Ireland) University Hospital Limerick (Limerick, Ireland) University Hospital Motol (Prague, Czech Republic) University Hospital Of Olomouc (Olomouc, Czech Republic) University Hospital Virgen del Rocio (Sevilla, Spain) University Hospital Waterford (Waterford, Ireland) University Hospital of Patras (Patras, Greece) University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary (Leicester, United Kingdom) University Med. Center Anam (Seoul, Korea (Republic of)) University Med. Center Anam (Seoul, Korea (Republic of)) University of Debrecen Medical Health Care Center (Debrecen, Hungary) VITA-34 Florence-Nightingale-Krankenhaus (Duesseldorf, Germany) Veszprem Megyei Tudogyogyintezet (Farkasgyepű , Hungary) Vivantes Klinikum Neukoelln (Berlin - Neukoelln, Germany) Vorarlberger Landeskrankenhaus - Hospital Rankweil (Rankweil, Austria) Wythenshawe Hospital (MFT) (Wythenshawe, Manchester, United Kingdom) Ziekenhuis St Jansdal (Harderwijk, Netherlands) Zuyderland Medisch Centrum, Heerlen (Heerlen, Netherlands)
Protocol summary	http://clinicaltrials.gov/study/NCT02504372
NCT number	NCT02504372
EudraCT	2015-000575-27
Financial Support	Fully supported