LT-FU ongoing

Date of activation: 10-Nov-2015
Date Step1 close: 20-May-2020
Date Step2 close: 20-May-2020

Yes

Phase 3
Randomized blind

All Groups: 1080

Drug
Pembrolizumab, Blind trial medication-1416

• Mary O'Brien (Study Coordinator), Royal Marsden Hospital - Sutton, Surrey, Surrey
• Luis Paz-Ares (Study Co-Coordinator), Hospital Universitario 12 De Octubre, Madrid
• Tina Verschuere (Project Manager), EORTC Headquarters, Brussels
• Sandrine Marreaud (Clinical Research Physician), EORTC Headquarters, Brussels
• Murielle Mauer (Statistician), EORTC Headquarters, Brussels
• Herve Azobou (Statistical Analyst), EORTC Headquarters, Brussels
• Nitish Jha (Statistical Analyst), EORTC Headquarters, Brussels
• Fanny Grillet (TR Scientist), EORTC Headquarters, Brussels
• Sofie Verschueren (Senior Clinical Operations Manager), EORTC Headquarters, Brussels
• Piet Gutscoven (Data Manager), EORTC Headquarters, Brussels
• Cathy Van de Wiele (Data Manager), EORTC Headquarters, Brussels
• Yuliya Vostrikova (Clinical Data Expert), EORTC Headquarters, Brussels
• Sandrine Rivrain (Pharmacovigilance Manager), EORTC Headquarters, Brussels
• Veronica De Simone (Translational Research Operations Manager (TROM)), EORTC Headquarters, Brussels
• Katrien Baus (Admin. assistant DM), EORTC Headquarters, Brussels
• Beatrice Fournier (Unblinded Clinical Scientist), EORTC Headquarters, Brussels
• Gaetan de Schaetzen (Unblinded COM), EORTC Headquarters, Brussels
• Corneel Coens (Unblinded statistician), EORTC Headquarters, Brussels

• Lung

• EORTC Lung Cancer Group
• ETOP IBCSG Partners Foundation

• 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 Sanchinarro-CIOCC (Madrid, Spain)
• Hyogo Cancer Center (Akashi-shi, Japan)
• IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, 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 (Gyonogyos, Hungary)
• Medical Oncology Sunshine Hospital Western Health (Saint Albans, Australia)
• Meir Hospital (Kfar Saba, Israel)
• 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 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)
• 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 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 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 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)

• George Papanicolaou General Hospital (Thessaloniki, Greece)
• Hospital Bruno Born (Lajeado, Brazil)
• Kantonsspital Winterthur (Winterthur, Switzerland)
• Kindai University Hospital (Osaka, Japan)
• Kyorin University Hospital (Tokyo, Japan)
• Universitaetsspital Basel (Basel, Switzerland)

http://clinicaltrials.gov/study/NCT02504372

NCT02504372

2015-000575-27