255
Participants
Start Date
April 20, 2021
Primary Completion Date
January 26, 2023
Study Completion Date
October 17, 2024
Pembrolizumab/Vibostolimab coformulation
Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.
Docetaxel
Docetaxel 75 mg\^m2 IV infusion Q3W until discontinuation due to progressive disease or unacceptable toxicity. Docetaxel will serve as part of an experimental treatment in Arm 1, and as an active comparator in Arm 3.
Placebo
Normal saline IV infusion Q3W up to approximately 2 years
NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 2302), Tainan City
UZ Brussel ( Site 0336), Brussels
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0204), Vienna
AZ Nikolaas ( Site 0334), Sint-Niklaas
Rigshospitalet ( Site 0702), Copenhagen
Canberra Hospital ( Site 0104), Canberra
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0333), Mechelen
Jessa Ziekenhuis-Pulmonology & Thoracic Oncology ( Site 0338), Hasselt
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0203), Linz
Gold Coast University Hospital-Clinical Trials Service ( Site 0106), Southport
Odense Universitetshospital ( Site 0700), Odense
Hospital Privado Universitario de Córdoba ( Site 0001), Córdoba
Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0337), Charleroi
Fiona Stanley Hospital-Medical Oncology ( Site 0102), Murdoch
Sygehus Soenderjylland-Kraeftambulatoriet ( Site 0705), Sønderborg
Ospedale Regionale Bellinzona e Valli ( Site 2203), Bellinzona
Hospital Privado de Comunidad ( Site 0004), Mar del Plata
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0002), Mar del Plata
Medizinische Universität Graz ( Site 0201), Graz
National Taiwan University Hospital-Oncology ( Site 2304), Taipei
Azienda Sanitaria Ospedaliera S Luigi Gonzaga-Oncologia Polmonare ( Site 1300), Orbassano
Chulalongkorn University ( Site 2403), Bangkok
Mackay Memorial Hospital-Chest Medicine ( Site 2305), Taipei
Montefiore- Einstein Center for Cancer Care-Oncology ( Site 2509), The Bronx
Faculty of Medicine Siriraj Hospital ( Site 2400), Bangkok
Seoul National University Bundang Hospital ( Site 2003), Seongnam
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1006), Caen
Helios Klinikum Emil von Behring Berlin-Zehlendorf ( Site 1106), Berlin
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 2005), Suwon
Ospedale San Raffaele-Oncologia Medica ( Site 1305), Milan
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1301), Milan
Turku University Hospital-The Department of Pulmonary Medicine ( Site 0905), Turku
University of Maryland ( Site 2528), Baltimore
Hospital Tengku Ampuan Afzan ( Site 1500), Kuantan
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2101), Madrid
Chungbuk National University Hospital-Internal medicine ( Site 2004), Cheongju-si
St Francis Cancer Center-Research Office ( Site 2531), Greenville
CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1008), Toulouse
Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1009), Bordeaux
CRO-IRCCS-medical oncology ( Site 1304), Aviano
Tampereen yliopistollinen sairaala-Oncology ( Site 0906), Tampere
Hattiesburg Clinic Hematology/Oncology ( Site 2511), Hattiesburg
Baptist Health Lexington-Research ( Site 2502), Lexington
Taichung Veterans General Hospital-Chest ( Site 2307), Taichung
Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 2103), Seville
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 2526), Cincinnati
Beacon Hospital Sdn Bhd ( Site 1504), Petaling Jaya
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1306), Florence
Universitätsklinikum Bonn ( Site 1111), Bonn
University Malaya Medical Centre ( Site 1501), Lembah Pantai
Illinois Cancer Care ( Site 2534), Peoria
Clinique Ambroise Paré ( Site 1007), Beuvry
Mercy Research - David C. Pratt Cancer Center ( Site 2532), St Louis
Vaasan Keskussairaala ( Site 0903), Vaasa
Helios Dr. Horst Schmidt Kliniken ( Site 1108), Wiesbaden
Mercy Research - Cancer and Hematology Center ( Site 2535), Springfield
Nouvel Hôpital Civil (NHC) ( Site 1000), Strasbourg
Centre Hospitalier du Mans ( Site 1002), Le Mans
Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1308), Naples
Hospital Sultan Ismail ( Site 1503), Johor Bahru
Chang Gung Memorial Hospital at Kaohsiung ( Site 2303), Kaohsiung Niao Sung Dist
Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1004), Avignon
Klinikverbund Allgaeu gGmbH ( Site 1109), Immenstadt im Allgäu
Onkologie Ravensburg ( Site 1104), Ravensburg
Cedars-Sinai Medical Center ( Site 2522), Los Angeles
Oulun yliopistollinen sairaala ( Site 0902), Oulu
Gustave Roussy ( Site 1005), Villejuif
Moscow Clinical Research Center-Chemotherapy department ( Site 1910), Moscow
Hadassah Medical-Oncology department ( Site 1912), Moscow
Central Clinical Hospital of the Presidential Administrative Department ( Site 1902), Moscow
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (, Saint Petersburg
GBUZ LOKB-Oncology department #1 ( Site 1905), Saint Petersburg
N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S, Saint Petersburg
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1911), Saint Petersburg
Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 1909), Nizhny Novgorod
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary ( Site 1908), Omsk
Rambam Health Care Campus-Oncology ( Site 1203), Haifa
Sourasky Medical Center ( Site 1205), Tel Aviv
Soroka Medical Center ( Site 1202), Beersheba
Shaare Zedek Medical Center-Oncology ( Site 1206), Jerusalem
Centro de Oncología e Investigación de Buenos Aires ( Site 0008), Berazategui
Instituto de Oncología de Rosario ( Site 0003), Rosario
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0005), La Rioja
Hospital Nossa Senhora da Conceição ( Site 0403), Porto Alegre
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0400), São Paulo
Centro de Tratamento de Tumores Botafogo - CTTB-Pesquisa Clínica ( Site 0402), Rio de Janeiro
Hospital Paulistano ( Site 0406), São Paulo
HIA Sainte Anne ( Site 1003), Toulon
Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1307), Rome
Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1303), Roma
Przychodnia Lekarska KOMED ( Site 1704), Konin
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier, Warsaw
Asan Medical Center-Oncology ( Site 2000), Songpagu
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit, Barcelona
Hospital de la Santa Creu i Sant Pau-Oncología Médica ( Site 2102), Barcelona
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INDUSTRY