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Brief Title: Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)
Official Title: A Phase III Open-Label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer That Has Progressed After a Platinum-Containing Doublet
Study ID: NCT02395172
Brief Summary: The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama, Tuscaloosa, Alabama, United States
Mayo Clinic, Scottsdale , Phoenix, Arizona, United States
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
Healing Hands Oncology and Medical Care, Lawndale, California, United States
Sutter Gould Medical Foundation, Modesto, California, United States
Sharp Memorial Hospital, San Diego, California, United States
Lynn Cancer Institute Center, Boca Raton, Florida, United States
University Cancer Institute, Boynton Beach, Florida, United States
Holy Cross Hospital Inc., Fort Lauderdale, Florida, United States
Florida Cancer Specialists-Broadway, Fort Myers, Florida, United States
Florida Cancer Specialists, Saint Petersburg, Florida, United States
Florida Cancer Specialists, West Palm Beach, Florida, United States
Northeast Georgia Cancer Care, LLC, Athens, Georgia, United States
Metairie Oncologist, LLC, Metairie, Louisiana, United States
Henry Ford Health System, Detroit, Michigan, United States
Hematology Oncology Associates of Rockland, Nyack, New York, United States
Novant Health Oncology Specialists, Winston-Salem, North Carolina, United States
Oncology Hematology Care, Cincinnati, Ohio, United States
Signal Point Clinical Research Center, Middletown, Ohio, United States
Mercy Clinic Oklahoma Communities, Inc., Oklahoma City, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Penn State Univ. Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Center for Biomedical Research, LLC, Knoxville, Tennessee, United States
SCRI - Tennessee Oncology, Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
University of Texas Health Science Center at Tyler, Tyler, Texas, United States
MultiCare Health System, Tacoma, Washington, United States
Hospital Italiano Regional del Sur, Bahia Blanca, , Argentina
Clínica Universitaria Privada Reina Fabiola, Barrio General Paz, , Argentina
Centro de Oncologia e Investigacion Buenos Aires, Berazategui, , Argentina
Instituto Medico Especializado Alexander Fleming, Ciudad Autonoma Buenos Aires, , Argentina
CEMIC, Ciudad Autonoma Buenos Aires, , Argentina
Instituto DAMIC Fundacion Rusculleda, Cordoba, , Argentina
Centro Oncologico Riojano Integral (Cori), La Rioja, , Argentina
Centro Oncologico de Parana, Parana, , Argentina
Hospital Universitario Austral, Pilar, , Argentina
Instituto Gamma, Rosario, , Argentina
Sanatorio Parque S.A., Rosario, , Argentina
Instituto de Oncología de Rosario, Rosario, , Argentina
Centro Medico San Roque S.R.L., San Miguel de Tucuman, , Argentina
Ballarat Base Hospital, Ballarat, , Australia
Box Hill Hospital, Box Hill, , Australia
Coffs Harbour Base Hospital, Coffs Harbour, , Australia
Lyell McEwin Hospital, Elizabeth Vale, , Australia
Greenslopes Private Hospital, Greenslopes, , Australia
Lismore Base Hospital, Lismore, , Australia
Royal Melbourne Hospital, Parkville, , Australia
St John of God Hospital, Subiaco, , Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
UZ Antwerpen, Edegem, , Belgium
Grand Hôpital de Charleroi, Gilly, , Belgium
UZ Leuven, Leuven, , Belgium
Centre Hospitalier de l'Ardenne, Libramont, , Belgium
C. H. U. Sart Tilman, Liège, , Belgium
AZ Delta, Roeselare, , Belgium
Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda, Belo Horizonte, , Brazil
CEPON - Centro de Pesquisas Oncológicas de Santa Catarina, Florianópolis, , Brazil
Hospital de Caridade de Ijuí, Ijuí, , Brazil
Clínica de Neoplasias Litoral Ltda., Itajaí, , Brazil
CMiP - Centro Mineiro de Pesquisa, Juiz de Fora, , Brazil
Hospital Bruno Born, Lajeado, , Brazil
Liga Norte-Rio-Grandense Contra o Câncer, Natal, , Brazil
Oncosinos - Clínica de Oncologia - Hospital Regina, Novo Hamburgo, , Brazil
CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo, Passo Fundo, , Brazil
Hospital Mãe de Deus, Porto Alegre, , Brazil
Hospital São Lucas da PUCRS, Porto Alegre, , Brazil
COI - Clínicas Oncológicas Integradas, Rio de Janeiro, , Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia, Santo André, , Brazil
IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado", Sorocaba, , Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto, , Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, São Paulo, , Brazil
UMHAT 'Dr. Georgi Stranski', EAD, Pleven, , Bulgaria
Complex Oncological Center - Plovdiv, EOOD, Plovdiv, , Bulgaria
MHAT "Serdika", EOOD, Sofia, , Bulgaria
MHAT 'Tokuda Hospital Sofia', AD, Sofia, , Bulgaria
Shato, Ead, Sofia, , Bulgaria
MHAT 'Sv. Marina', EAD, Varna, , Bulgaria
Instituto de Terapias Oncologicas Providencia, Santiago, , Chile
FALP - Fundación Arturo López Pérez, Santiago, , Chile
CIEC - Centro Internacional de Estudios Clínicos, Santiago, , Chile
Instituto Clinico Oncologico del Sur (ICOS), Temuco, , Chile
Centro de Investigaciones Clinicas Viña del Mar, Viña del Mar, , Chile
Hospital Clinico Viña del Mar, Viña del Mar, , Chile
Fundacion Cardioinfantil Instituto de Cardiologia, Bogota, , Colombia
Instituto Nacional de Cancerologia E.S.E., Bogota, , Colombia
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia, Bogota, , Colombia
Administradora Country S.A., Bogotá, , Colombia
Fundación Valle del Lilí, Cali, , Colombia
Centro Medico Imbanaco, Cali, , Colombia
Hemato Oncologos S.A., Cali, , Colombia
Instituto de Cancerologia S.A., Medellin, , Colombia
Hospital Pablo Tobón Uribe, Medellín, , Colombia
IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A., Monteria, , Colombia
General Hospital Dubrovnik, Dubrovnik, , Croatia
General Hospital Zadar, Zadar, , Croatia
Clinical Hospital Centar "Sestre Milosrdnice", Zagreb, , Croatia
University Clinic for Pulmonary Diseases, Zagreb, , Croatia
Masarykuv onkologicky ustav, Brno, , Czechia
Nemocnice Novy Jicin a.s., Novy Jicin, , Czechia
Multiscan s.r.o., Pardubice, , Czechia
Vseobecna fakultni nemocnice V Praze, Praha 2, , Czechia
Thomayerova nemocnice, Praha 4, , Czechia
Herlev Hospital, Herlev, , Denmark
Odense Universitetshospital, Odense C, , Denmark
ICO - Site Paul Papin, Angers Cedex 9, , France
CHU Besançon - Hôpital Jean Minjoz, Besancon Cedex, , France
Clinique Victor Hugo - Centre Jean Bernard, Le Mans Cedex 02, , France
Hôpital Nord - AP-HM Marseille#, Marseille cedex 20, , France
Centre Catherine de Sienne, Nantes, , France
Centre Antoine Lacassagne, Nice cedex 02, , France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque, Pessac, , France
CHU Poitiers - Hôpital la Milétrie, Poitiers, , France
ICO - Site René Gauducheau, Saint Herblain, , France
CHU Strasbourg - Nouvel Hôpital Civil, Strasbourg, , France
CHU de Toulouse - Hôpital Larrey, Toulouse, , France
Semmelweis Egyetem AOK, Budapest, , Hungary
Uzsoki Utcai Korhaz, Budapest, , Hungary
Petz Aladar Megyei Oktato Korhaz, Györ, , Hungary
Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Miskolc, , Hungary
Tudogyogyintezet Torokbalint, Torokbalint, , Hungary
Soroka Medical Center, Beer Sheva, , Israel
Assaf Harofeh Medical Center, Beer Yaakov, , Israel
Rambam Health Care Campus, Haifa, , Israel
The Lady Davis Carmel Medical Center, Haifa, , Israel
Hadassah University Hospital - Ein Kerem, Jerusalem, , Israel
Sapir Medical Center, Meir Hospital, Kfar-Saba, , Israel
Rabin Medical Center-Beilinson Campus, Petach Tikva, , Israel
Chaim Sheba Medical Center, Ramat-Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliera Istituti Ospitalieri di Cremona, Cremona, , Italy
Ospedale Mater Salutis, Legnago (VR), , Italy
Ospedale Versilia, Lido di Camaiore, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
IEO Istituto Europeo di Oncologia, Milano, , Italy
Seconda Università degli Studi di Napoli, Napoli, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
Università Campus Bio-Medico di Roma, Roma, , Italy
Istituto Nazionale Tumori Regina Elena IRCCS, Roma, , Italy
Policlinico Universitario Agostino Gemelli, Roma, , Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza, Roma, , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena, , Italy
Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio, Treviglio, , Italy
National Cancer Center Hospital, Chuo-ku, , Japan
NHO Kyushu Cancer Center, Fukuoka-shi, , Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino-shi, , Japan
Hiroshima City Hiroshima Citizens Hospital, Hiroshima-shi, , Japan
National Cancer Center Hospital East, Kashiwa-shi, , Japan
Saitama Cancer Center, Kitaadachi-gun, , Japan
Institute of Biomedical Research and Innovation Hospital, Kobe-shi, , Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital, Kobe-shi, , Japan
Cancer Institute Hospital of JFCR, Koto-ku, , Japan
Kurume University Hospital, Kurume-shi, , Japan
Miyagi Cancer Center, Natori-shi, , Japan
Aichi Cancer Center Hospital, Okazaki-shi, , Japan
Osaka City General Hospital, Osaka-shi, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka-shi, , Japan
Kinki University Hospital, Osakasayama-shi, , Japan
Kitasato University Hospital, Sagamihara-shi, , Japan
NHO Hokkaido Cancer Center, Sapporo-shi, , Japan
Hokkaido University Hospital, Sapporo-shi, , Japan
Tokyo Medical University Hospital, Shinjuku-ku, , Japan
Toyama University Hospital, Toyama-shi, , Japan
Wakayama Medical University Hospital, Wakayama-shi, , Japan
Yokohama Municipal Citizen's Hospital, Yokohama-shi, , Japan
Kanagawa Cancer Center, Yokohama-shi, , Japan
Chungbuk National University Hospital, Cheongju-si, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun-gun, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital, Suwon-si, , Korea, Republic of
Phylasis Clinicas Research S de RL de CV, Cuautitlan Izcalli, , Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C., Durango, , Mexico
Fundacion Rodolfo Padilla Padilla, A.C., Leon, , Mexico
Health Pharma Professional Research S.A. de C.V., Mexico, , Mexico
Winsett Rethman S.A. de C.V., Monterrey, , Mexico
Centro de Investigacion Clinica Chapultepec S.A. de C.V., Morelia, , Mexico
Oaxaca Site Management Organization S.C., Oaxaca, , Mexico
Centro Oncologico Estatal ISSEMyM, Toluca, , Mexico
Clinica Monte Carmelo, Arequipa, , Peru
Hospital Nacional Almanzor Aguinaga Asenjo, Chiclayo, , Peru
Hospital Nacional Adolfo Guevara Velasco, Cusco, , Peru
Clinica San Borja, Lima, , Peru
Hospital Nacional Guillermo Almenara Irigoyen, Lima, , Peru
Clínica Ricardo Palma, Lima, , Peru
Instituto Nacional de Enfermedades Neoplásicas, Lima, , Peru
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza, Brzozow, , Poland
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej, Jelenia Gora, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 5 SUM, Katowice, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna, Lodz, , Poland
KO-MED Centra Kliniczne Lublin II, Lublin, , Poland
SSZZOZ im. Dr Teodora Dunina w Rudce, Mrozy, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy, Otwock, , Poland
Spitalul Judetean de Urgenta Alba Iulia, Alba Iulia, , Romania
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare, Baia Mare, , Romania
Policlinica de Diagnostic Rapid SRL, Brasov, , Romania
Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea, Oradea, , Romania
Spital Lotus SRL, Ploiesti, , Romania
S.C Oncocenter Oncologie Clinica S.R.L, Timisoara, , Romania
SHI "Republican Clinical Oncological Dispensary of HM RT", Kazan, , Russian Federation
SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow, Moscow, , Russian Federation
FSBHI Clinical research institute of phthisiopulmonology, Saint Petersburg, , Russian Federation
Pavlov First Saint Petersburg State Medical University, Saint Petersburg, , Russian Federation
St. Petersburg SHI "City Clinical Oncology Dispensary", St. Petersburg, , Russian Federation
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov", St. Petersburg, , Russian Federation
Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov, Bardejov, , Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov, Bratislava, , Slovakia
Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica, Ruzomberok, , Slovakia
Fakultna nemocnica Trnava, Trnava, , Slovakia
GVI Cape Gate Oncology Centre, Cape Town, , South Africa
GVI Rondebosch Oncology Centre, Cape town, , South Africa
GVI Langenhoven Drive Oncology Centre, Port Elizabeth, , South Africa
University of Pretoria Oncology Department, Pretoria, , South Africa
Mary Potter Oncology Centre, Pretoria, , South Africa
Hospital General Universitario de Alicante, Alicante, , Spain
ICO Badalona - Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Universitari Quiron Dexeus, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
ICO l´Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat, , Spain
Hospital Universitario Materno-Infantil de Canarias, Las Palmas de Gran Canaria, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Centro Integral Oncologico Clara Campal, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria, Malaga, , Spain
Hospital de Mataro, Mataro, , Spain
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Kantonsspital Graubuenden, Chur, , Switzerland
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou, Taoyuan County, , Taiwan
Hacettepe University Medical Faculty, Ankara, , Turkey
Baskent University Ankara Hospital, Ankara, , Turkey
Ankara University Medical Faculty, Ankara, , Turkey
Trakya University Medical Faculty, Edirne, , Turkey
Bezmi Alem Foundation University Medical Faculty Hospital, Istanbul, , Turkey
Istanbul University Cerrahpasa Medical Faculty, Istanbul, , Turkey
Fatih Universitesi Tip Fakultesi, Istanbul, , Turkey
Marmara University Pendik Research and Training Center, Istanbul, , Turkey
Ege University Medical Faculty, Izmir, , Turkey
Dokuz Eylul University Medicine Faculty, Izmir, , Turkey
Konya Necmettin Erbakan University Meram Faculty of Medicine, Konya, , Turkey
Royal Bournemouth General Hospital, Bournemouth, , United Kingdom
Bristol Haematology & Oncology Centre, Bristol, , United Kingdom
Royal Devon and Exeter Hospital (Wonford), Exeter, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
St James's University Hospital, Leeds, , United Kingdom
University College London Hospital, London, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Mount Vernon Hospital, Stevenage, , United Kingdom
The Clatterbridge Cancer Centre, Wirral, , United Kingdom
Name: Medical Responsible
Affiliation: EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR