Spots Global Cancer Trial Database for M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)
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Trial Identification
Brief Title: M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)
Official Title: An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (Bintrafusp Alfa) Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer
Study ID: NCT03631706
Conditions
Study Description
Brief Summary: The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Oncology Specialties, PC; Clearview Cancer Institute, Huntsville, Alabama, United States
Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (Clinic, Los Angeles, California, United States
UC Irvine Medical Center, Orange, California, United States
Kaiser Permanente - Harbor City, San Diego, California, United States
Sansum Clinic - Santa Barbara, Santa Barbara, California, United States
Rocky Mountain Cancer Centers - Colorado Springs, N. Nevada, Colorado Springs, Colorado, United States
Eastern Connecticut Hematology/Oncology Assoc., Norwich, Connecticut, United States
Cancer Specialists, LLC - Department of Clinical Research, Jacksonville, Florida, United States
Woodlands Medical Specialists, Pensacola, Florida, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Decatur Memorial Hospital - Clinical Research, Decatur, Illinois, United States
Baptist Health Lexington Oncology Associates, Lexington, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Henry Ford Medical Center, Detroit, Michigan, United States
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC - Menorah Medical Center - Oncology Account, Kansas City, Missouri, United States
Southeast Nebraska Cancer Center, Lincoln, Nebraska, United States
The Valley Hospital - Luckow Pavilion, Paramus, New Jersey, United States
University of Rochester Medical Center, Rochester, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States
SCRI - Tennessee Oncology, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Texas Oncology - Bedford, Bedford, Texas, United States
Texas Oncology, P.A. - Sugarland, Sugar Land, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Centro de Oncologia e Investigacion Buenos Aires, Berazategui, , Argentina
Instituto Medico Especializado Alexander Fleming, Ciudad Autonoma Buenos Aires, , Argentina
Sanatorio Allende, Cordoba, , Argentina
Instituto Medico Rio Cuarto, Rio Cuarto, , Argentina
Instituto de Oncología de Rosario, Rosario, , Argentina
Centro Medico San Roque S.R.L., San Miguel de Tucuman, , Argentina
Universitair Ziekenhuis Brussel - Geriatrie, Bruxelles, , Belgium
Jessa Ziekenhuis Hospital, Hasselt, , Belgium
UZ Leuven, Pellenberg, , Belgium
CHU Mont-Godinne, Yvoir, , Belgium
Hospital de Câncer de Barretos - Fundação Pio XII, Barretos, , Brazil
CRIO - Centro Regional Integrado de Oncologia, Fortaleza, , Brazil
Hospital São Lucas da PUCRS, Porto Alegre, , Brazil
INCA - Instituto Nacional de Câncer, Rio de Janeiro, , Brazil
NOB - Núcleo de Oncologia da Bahia, Salvador, , Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia - Faculdade de Medicina do ABC, Santo Andre, , Brazil
Saint John Regional Hospital, St. John, New Brunswick, Canada
Tom Baker Cancer Centre, Alberta, , Canada
Stronach Regional Cancer Centre - at Southlake, Ontario, , Canada
Peking University Cancer Hospital, Beijing, , China
Guangdong General Hospital, Guangzhou, , China
Shanghai Cancer Hospital, Fudan University, Shanghai, , China
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha, Pessac, Gironde, France
Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie, Creteil Cedex, Val De Marne, France
Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire, Bouches-du-Rhône, , France
Centre Léon Bérard, Lyon Cedex 08, , France
CHU Rennes - Hopital Pontchaillou - service de pneumologie, Rennes cedex 09, , France
ICO - Site René Gauducheau, Saint Herblain, , France
CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique, Toulouse, , France
Vivantes Klinikum Am Urban - Haematologie und Onkologie, Berlin, , Germany
Asklepios Fachkliniken Muenchen-Gauting - Abteilung Internistische Onkologie, Gauting, , Germany
LungenClinic Grosshansdorf, Grosshansdorf, , Germany
Medizinische Hochschule Hannover - Pneumologie, Hannover, , Germany
Universitaetsklinikum Schleswig- Holstein Campus Luebeck, Luebeck, , Germany
Universitaetsklinikum Regensburg - Klinik und Poliklinik fuer Innere Medizin II, Regensburg, , Germany
251 General Air Force Hospital, Athens, , Greece
General Hospital of Athens of Chest Disease "SOTIRIA", Athens, , Greece
University General Hospital of Heraklion "PAGNI", Heraklion, , Greece
General Hospital Papageorgiou-2nd Department of Dermatalogy, Thessaloniki, , Greece
Princess Margaret Hospital, Hong Kong, , Hong Kong
The University of Hong Kong, Hong Kong, , Hong Kong
The Chinese University of Hong Kong - Emergency Medicine, Shatin, , Hong Kong
Azienda Ospedaliera San Giuseppe Moscati - U.O Oncologia Medica, Avellino, , Italy
IRCCS Centro di Riferimento Oncologico - Oncologia Medica A, Aviano, , Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Oncologia Medica, Bologna, , Italy
Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico - Unità Operativa di Oncologia, Catania, , Italy
Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario - Centro Oncologico, Catanzaro, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - Medicina Oncologica I, Milano, , Italy
Università degli studi della Campania Luigi Vanvitelli - Dipartimento di Oncologia, Napoli, , Italy
NHO Hokkaido Cancer Center - Dept of Respiratory Medicine, Sapporo-shi, Hokkaido, Japan
National Cancer Center Hospital - Dept of Respiratory Medicine, Chuo-ku, , Japan
Saitama Medical University International Medical Center - Dept of Respiratory Medicine, Hidaka-shi, , Japan
Saitama Cancer Center, Kitaadachigun, , Japan
Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine, Koto-ku, , Japan
Kurume University Hospital, Kurume-shi, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka-shi, , Japan
Kindai University Hospital, Osakasayama-sh, , Japan
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
VU Medisch Centrum, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen (UMCG) - Parent, Groningen, , Netherlands
Maastricht University Medical Center - Dept of Medical Oncology, Maastricht, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
St. Elisabeth Ziekenhuis - Parent, Tilburg, , Netherlands
Hospital del Mar - Servicio de Oncologia, Barcelona, , Spain
Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica, Barcelona, , Spain
Hospital Universitari Vall d'Hebron - Dept of Oncology, Barcelona, , Spain
ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia, L'Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica, Madrid, , Spain
Hospital Universitario 12 de Octubre - Servicio de Oncologia, Madrid, , Spain
Hospital Regional Universitario de Malaga, Málaga, , Spain
Hospital Universitario Virgen Macarena - Servicio de Oncologia, Sevilla, , Spain
Hospital Universitario Virgen del Rocio - Servicio de Oncologia, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica, Valencia, , Spain
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Adana Numune Training and Research Hospital - Cardiology Department, Adana, , Turkey
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital - Oncology Department, Ankara, , Turkey
Trakya University Medical Faculty - Medical Oncology, Edirne, , Turkey
Kocaeli University Research and Application Hospital, Kocaeli, , Turkey
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU - Ch of Oncology and MR, Dnipro, , Ukraine
CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU - Chair of Oncology, Ivano-Frankivsk, , Ukraine
Communal Non-profit Enterprise Regional Center of Oncology - Parent, Kharkiv, , Ukraine
Medical and Preventive Treatment Institution Volyn Regional Oncological Dispensary - Dept of Oncochemotherapy, Lutsk, , Ukraine
CCCH City Oncological Center SHEI Uzhgorod NU - Ch of R&O of Faculty of PGE&PUT, Uzhgorod, , Ukraine
Medical center "Oncolife", Zaporizhzhia, , Ukraine
Contact Details
Name: Medical Responsible
Affiliation: Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
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