Spots Global Cancer Trial Database for A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer
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Trial Identification
Brief Title: A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer
Official Title: A PHASE 3, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED STUDY OF TISLELIZUMAB (BGB-A317) PLUS CHEMORADIOTHERAPY FOLLOWED BY TISLELIZUMAB MONOTHERAPY IN NEWLY DIAGNOSED, STAGE III SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE NON-SMALL CELL LUNG CANCER
Study ID: NCT03745222
Conditions
Study Description
Brief Summary: This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Cancer Specialists of North Florida - Jacksonville, Jacksonville, Florida, United States
Bond Clinic, P.A., Winter Haven, Florida, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
Appalachian Regional Healthcare, Inc., Hazard, Kentucky, United States
Norton Healthcare - Norton Cancer Institute, Louisville, Kentucky, United States
Center For Cancer and Blood Disorders, Bethesda, Maryland, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Dayton Physicians, LLC, Kettering, Ohio, United States
Mercy Health Youngstown Hospital, LLC, Youngstown, Ohio, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Millennium Oncology, Houston, Texas, United States
Medical Oncology Associates, P.S., Spokane, Washington, United States
Universitair Ziekenhuis Brussel, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Jewish General Hospital, Montreal, Quebec, Canada
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, , China
Chinese PLA General Hospital / 307 Hospital, Beijing, , China
Beijing Cancer Hospital - Beijing Institute for Cancer Research, Beijing, , China
Bengbu Medical College - First Affiliated Hospital, Bengbu Shi, , China
Jilin Province Cancer Hospital, Changchun Shi, , China
First Hospital of Jilin University, Changchun, , China
Central South University - Xiangya School of Medicine - Hunan Cancer Hospital, Changsha-shi, , China
Central South University - Xiangya School of Medicine - Hunan Cancer Hospital, Changsha, , China
Sichuan Cancer Hospital & Institute, Chengdu, , China
Sichuan University - West China Hospital, Chengdu, , China
Foshan First People's Hospital, Foshan, , China
Fujian Medical University - Fujian Provincial Cancer Hospital, Fuzhou Shi, , China
Cancer Center of Guangzhou Medical University, Guangzhou, , China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, , China
Zhejiang University School of Medicine - The Second Affiliated Hospital, Hangzhou, , China
Zhejiang Medical University - Zhejiang Cancer Hospital, Hangzhou, , China
The First Affiliated Hospital of Harbin Medical University, Harbin, , China
Yunnan Cancer Hospital, Kunming Shi, , China
Guangxi Tumour Institute and Hospital, Nanning, , China
Nantong Tumor Hospital, Nantong, , China
Shanghai Chest Hospital, Shanghai Shi, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Chongqing Cancer Hospital, Shapingbaqu, , China
Liaoning Cancer Hospital & Institute, Shenyang Shi, , China
The First Hospital of Xinjiang Medical University, Urumqi, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, , China
Zhongnan Hospital of Wuhan University, Wuhan, , China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, , China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an City, , China
First Hospital of Xiamen, Xiamen, , China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, , China
Zhengzhou University (ZZU) - Henan Cancer Hospital, Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
Tampereen yliopistollinen sairaala, Tampere, , Finland
Turku University Hospital, Turku, , Finland
Centre Francois Baclesse, Caen Cedex 5, , France
Clinique Victor Hugo, Le Mans, , France
Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain, Saint Herblain, , France
Medical Study Company NORD-WEST GmbH Oncology Aurich, Aurich, , Germany
Helios Klinikum Emil Von Behring, Berlin, , Germany
Florence Nightingale KH der Kaiserwerther Diakonie, Dusseldorf, , Germany
Klinikum Esslingen GmbH, Esslingen Am Neckar, , Germany
Asklepios Fachkliniken Muenchen Gauting, Gauting, , Germany
Oncological practice Goslar, Goslar, , Germany
Evangelisches Krankenhaus Hamm, Hamm, , Germany
Health Nordhessen Holding AG - Klinikum Kassel - Medical Clinic IV, Kassel, , Germany
Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim, Koln, , Germany
Klinik Loewenstein gGmbH, Loewenstein, , Germany
LMU Klinikum der Universität, München, , Germany
St. Antonius-Hospital, Schweiler, , Germany
Medizinische Studiengesellschaft Nord-West, Westerstede, , Germany
Sotiria Chest Hospital of Athens, Athens, , Greece
IASO General, Athens, , Greece
University General Hospital of Heraklion, Heraklion, , Greece
Agioi Anargyroi Cancer Hospital, Kifissia, , Greece
Metaxa Cancer Hospital of Piraeus, Piraeus, , Greece
Interbalkan Medical Center of Thessaloniki, Pylaia, , Greece
University General Hospital of Patras, Rio Patras, , Greece
Bioclinic Thessaloniki Galinos clinic, Thessaloniki, , Greece
EUROMEDICA General Clinic of Thessaloniki, Thessaloniki, , Greece
Papageorgiou General Hospital of Thessaloniki, Thessaloniki, , Greece
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Szekesfehervar, , Hungary
Pulmonary Institute Torokbalint, Torokbalint, , Hungary
Beacon Hospital, Dublin, , Ireland
St James Hospital, Dublin, , Ireland
MidWestern Regional Hospital, Limerick, , Ireland
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico, Catania, , Italy
IRCCS AziendaOspedaliera Universitaria San Martino, Genova, , Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.), Meldola, , Italy
Universita Campus Bio-Medico di Roma, Roma, , Italy
Istituto Nazionale Tumori Regina Elena di Roma, Roma, , Italy
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino-shi, , Japan
Kansai Medical University Hospital, Hirakata-shi, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
Kanazawa University Hospital, Kanazawa-shi, , Japan
Matsusaka Municipal Hospital, Matsusaka-shi, , Japan
Toranomon Hospital, Minato-ku, , Japan
Iwate Medical University Hospital, Morioka, , Japan
National Hospital Organization - Nagoya Medical Center, Nagoya-shi, , Japan
Nagoya University Hospital, Nagoya-shi, , Japan
Niigata Cancer Center Hospital, Niigata-shi, , Japan
Osaka City University Hospital, Osaka, , Japan
Gunma Prefectural Cancer Center, Ota-ku, , Japan
Kitasato University Hospital, Sagamihara, , Japan
Sendai Kousei Hospital, Sendai-shi, , Japan
Kanagawa Cardiovascular and Respiratory Center, Yokohama-shi, , Japan
Yokohama Municipal Citizen's Hospital, Yokohama-shi, , Japan
Chungbuk National University Hospital, Cheongju, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon si, , Korea, Republic of
Vrije Universiteit Medisch Centrum (VUMC), Amsterdam, , Netherlands
Gelre Hospitals, Zutphen, , Netherlands
Waikato Hospital, Hamilton, , New Zealand
Tauranga Hospital, Tauranga, , New Zealand
Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz, , Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie, Gliwice, , Poland
Med Polonia Sp. z o.o. NSZOZ, Poznan, , Poland
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie, Warszawa, , Poland
Hospital Prof. Doutor Fernando Fonseca, Amadora, , Portugal
Centro Hospitalar E Universitario de Coimbra EPE, Coimbra, , Portugal
Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes, Guimaraes, , Portugal
CUF Descobertas Hospital, Lisboa, , Portugal
Centro Hospitalar do Porto - Hospital de Santo António, Porto, , Portugal
CUF Porto Hospital, Porto, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe, Porto, , Portugal
Oncology Institute Professor Doctor Alexandru Trestioreanu, Bucharest, , Romania
Prof. Dr. I. Chiricuta Institute of Oncology, Cluj-Napoca, , Romania
Medisprof SRL, Cluj-Napoca, , Romania
Sf. Apostol Andrei Constanta Emergency Clinical County Hospital, Constanta, , Romania
Oncology Center Sfantul Nectarie, Craiova, , Romania
Life Search SRL, Timisoara, , Romania
Oncocenter Clinical Oncology, Timisoara, , Romania
Principal Military Clinical Hospital n.a. N.N. Burdenko, Moscow, , Russian Federation
Omsk Regional Oncology Center, Omsk, , Russian Federation
Ryazan State Medical University n.a. I.P. Pavlov, Ryazan, , Russian Federation
Mordovia State University, Saransk, , Russian Federation
Clinical Hospital of the Russian Academy of Sciences, St. Petersburg, , Russian Federation
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology), St. Petersburg, , Russian Federation
Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov, St. Petersburg, , Russian Federation
National University Hospital, Singapore, , Singapore
Raffles Hospital, Singapore, , Singapore
Hospital Universitario a Coruna, A Coruna, , Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Universitario Germans Trias i Pujol, Barcelona, , Spain
Insular-Maternal and Child University Hospital Complex, Las Palmas de Gran Canaria, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Puerta de Hierro-Majadahonda, Majadahonda, Madrid, , Spain
Hospital General Carlos Haya, Malaga, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Buddhist Dalin Tzu Chi General Hospital, Dalin, , Taiwan
Kaohsiung Medical University Hospital, Kaohsiung, San Ming Dist., , Taiwan
E-DA Hospital, Kaohsiung, , Taiwan
Chang Gung Medical Foundation, Kaohsiung Memorial Hospital, Niao-Sung Hsiang Kaohsiung County, , Taiwan
National Taiwan University Hospital, Taipei, Zhongzheng Dist., , Taiwan
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital, Birmingham, , United Kingdom
East Suffolk and North Essex NHS Foundation Trust - Colchester Hospital, Colchester, , United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital, London, , United Kingdom
Guys Hospital, London, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital, Maidstone, , United Kingdom
Manchester University NHS Foundation Trust - Wythenshawe Hospital - North West Lung Centre, Manchester, , United Kingdom
The Hillingdon Hospitals NHS Foundation Trust - Mount Vernon Hospital, Northwood, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital, Sheffield South Yorkshire, , United Kingdom
Royal Cornwall Hospitals Trust, Truro, , United Kingdom
Contact Details
Name: Marie Nguyen, MD
Affiliation: Celgene
Role: STUDY_DIRECTOR
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