Spots Global Cancer Trial Database for Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)
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Trial Identification
Brief Title: Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy
Study ID: NCT06095583
Study Description
Brief Summary: The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy. Tifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator (BTLA). Toripalimab is a monoclonal antibody against programmed death protein-1 (PD-1). Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Goodyear, Arizona, United States
Banner University Medical Center, Tucson, Arizona, United States
Genesis Cancer and Blood Institute (Hot Springs, AR), Hot Springs, Arkansas, United States
SCRI Nashville, Davis, California, United States
Zangmeister Cancer Center (Columbus, OH), Los Angeles, California, United States
Los Angeles Hematology Oncology, Los Angeles, California, United States
University of Southern California Norris Comprehensive Cancer, Los Angeles, California, United States
Florida Cancer Specialists Pan Handle, Fort Myers, Florida, United States
Florida Cancer Specialists South, Fort Myers, Florida, United States
USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N, Miami, Florida, United States
Mid-Florida Hematology Oncology, Orange City, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Marietta, Georgia, United States
Norton Cancer Institute, Downtown, Multidisciplinary Clinic, Louisville, Kentucky, United States
American Oncology Partners of Maryland, PA, Bethesda, Maryland, United States
Dana Farber Cancer Institute-Hematology/Oncology, Boston, Massachusetts, United States
Karmanos Cancer Center, Detroit, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists, New York, New York, United States
University of Stony Brook, Stony Brook, New York, United States
Toledo Clinic Cancer Center - Toledo, Toledo, Ohio, United States
Oncology Associates Of Oregon, P.C., Eugene, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Millennium Physicians - Oncology, Houston, Texas, United States
Texas Oncology, P.A. - Oncology, Tyler, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Algemeen Ziekenhuis Klina, Antwerpen, , Belgium
Grand Hôpital de Charleroi - Site Notre-Dame, Charleroi, , Belgium
AZ Groeningen, Kortrijk, , Belgium
Jessa Ziekenhuis - Campus Virga Jesse, Limbourg, , Belgium
CHU UCL Namur - Site Sainte-Elisabeth, Namur, , Belgium
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Xiangya Hospital Central South University, Changsha, Hunan, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Shandong Cancer Hospital & Institute, Jinan, Shandong, China
Anyang Tumor Hospital, Anyang, , China
Beijing Cancer Hospital, Beijing, , China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, , China
Jilin Cancer Hospital, Changchun, , China
Hunan Cancer Hospital, Changsha, , China
Sichuan cancer hospital, Chengdu, , China
Chongqing University Cancer Hospital, Chongqing, , China
Peking University Shenzhen Hospital, Guangdong, , China
Sun Yat-sen University Cancer Center, Guangzhou, , China
No. 1 Bandong Road, Gongshu District, Hangzhou, Hangzhou, , China
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, , China
The First Affiliated Hospital of Ustc, Hefei, , China
Henan Cancer Hospital, Henan, , China
Affiliated Hospital of Jining Medical University, Jining, , China
The First Affiliated Hospital of Nanchang University, Nanchang, , China
The Second Affiliated Hospital of Nanchang University, Nanchang, , China
The Affiliated Hospital of Qingdao University, Qingdao, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Liaoning cancer hospital, Shenyang, , China
Shanxi Cancer hospital, Taiyuan, , China
Taizhou Hospital of Zhejiang Province, Taizhou, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
Hubei Cancer Hospital (Hubei Cancer Research Institute), Wuhan, , China
Zhongnan Hospital of Wuhan University, Wuhan, , China
The First Affiliated Hospital of Xiamen University, Xiamen, , China
General Hospital of Ningxia Medical University, Yinchuan, , China
Centre Hospitalier Universitaire D Angers, Angers, , France
Institut Bergonie, Bordeaux, , France
Centre Hospitalier Intercommunal De Créteil, Créteil, , France
CHU de Grenoble, Grenoble, , France
Centre Leon Berard - departement d'oncologie medicale, Lyon, , France
Centre de Cancérologie du Grand Montpellier, Montpellier, , France
Hopital Arnaud De Villeneuve - Oncologie/Pneumologie, Montpellier, , France
Hopital Haut-Leveque - Maladies respiratoires, Pessac, , France
Chu Hôpitaux De Rouen, Rouen, , France
Institut de Cancérologie de l'Ouest (ICO), Saint-Herblain, , France
Chru De Tours, Tours Cedex 9, , France
Institut Gustave Roussy, Villejuif, , France
"TIM - Tbilisi Institute of Medicine" LTD, Tbilisi, , Georgia
ICO-Institute of Clinical Oncology - Hospital, Tbilisi, , Georgia
ISR-GEO Med Res Clin Healthycore, Tbilisi, , Georgia
LTD "Israel-Georgian Medical Research Clinic Healthycore", Tbilisi, , Georgia
LTD "New Hospitals", Tbilisi, , Georgia
Ltd New Hospitals, Tbilisi, , Georgia
Multprofil Clinic Consilium Medulla, Tbilisi, , Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Tbilisi, , Georgia
Evangelische Lungenklinik Berlin, Berlin, , Germany
Klinikum Esslingen GmbH Klinik für Kardiologie, Angiolgie und Pneumolgoie, Esslingen, , Germany
Univeristätsklinikum Giessen und Marburg GmbH, Gießen, , Germany
Klinikum Kassel GmbH Klinik für Onkologie uind Hämatologie- Onkologisches Studiensekretariat, Kassel, , Germany
Gemeinschaftspraxis fuer Haematologie und Onkologie, Münster, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
PO G. Rodolico, AOU Policlinico-Vittorio Emanuele Catania, Catania, , Italy
Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS, Cesena, , Italy
Azienda Ospedaliero Universitaria Careggi, Firenze, , Italy
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Mod, Modena, , Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli, Napoli, , Italy
Iov, Irccs, Padova, , Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavia, Pavia, , Italy
AO S. Camillo-Forlanini, Roma, , Italy
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS Feasibility survey: PO di Livorno, AUSL Toscana Nord Ovest, SST, Roma, , Italy
Chungbuk National University Hospital, Cheonju, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Rijnstate Ziekenhuis, Arnhem, , Netherlands
Jeroen Bosch Ziekenhuis, Herzogenbusch, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
Isala Klinieken Zwolle, Zwolle, , Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku, Białystok, , Poland
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii, Olsztyn, , Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. E. i J. Zeylandow, Poznań, , Poland
Instytut Gruzlicy i Chorob Pluc, Warszawa, , Poland
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Cluj-Napoca, , Romania
Medisprof, Cluj-Napoca, , Romania
Centrul de Oncologie Sf. Nectarie, Craiova, , Romania
Oncolab, Craiova, , Romania
Radiotherapy Center Cluj, Floreşti, , Romania
Oncomed, Timişoara, , Romania
Hospital Universitari Dexeus Grupo Quironsalud, Barcelona, , Spain
C.H. Provincial de Castellón, Castellón De La Plana, , Spain
Centro Oncológico de Galicia, Coruña, , Spain
Complexo Hospitalario Universitario A Coruña, Coruña, , Spain
Complejo Hospitalario de Jaén, Jaén, , Spain
Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Complejo Hospitalario Universitario de Orense, Orense, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Universitario Donostia, San Sebastián, , Spain
Hospital Universitario Virgen De La Macarena, Sevilla, , Spain
Hospital Arnau De Vilanova De Valencia, Valencia, , Spain
Hospital Universitario Y Politécnico La Fe, Valencia, , Spain
H.C.U.Lozano Blesa, Zaragoza, , Spain
Taipei Veterans General Hospital, Taipei city, Taipei, Taiwan
No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C., Kaohsiung, , Taiwan
China Medical University Hospital - Internal Medicine - Taichung, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan City, , Taiwan
Chi Mei Hospital, Liouying - Department of Oncology, Tainan, , Taiwan
National Taiwan University Hospital - Internal Medicine, Taipei, , Taiwan
Taipei Medical University - Shuang Ho Hospital, Taipei, , Taiwan
Taipei Medical University - Taipei Medical University Hospital, Taipei, , Taiwan
Taipei Medical University - WanFang Hospital - Hematology and Oncology, Taipei, , Taiwan
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital, Taoyuan, , Taiwan
Ankara City Hospital, Ankara, , Turkey
Ankara Liv Hospital, Ankara, , Turkey
Gulhane Training and Research Hospital - Medical Oncology, Ankara, , Turkey
Memorial Ankara Hospital, Ankara, , Turkey
Trakya University Medical Faculty, Edirne, , Turkey
Bakirköy Dr. Sadi Konuk Eğitim ve Araştirma Hastanesi - Oncology, Istanbul, , Turkey
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology, Istanbul, , Turkey
Ege University Medical Faculty - Pulmonary, İzmir, , Turkey
İzmir Ekonomi Üniversitesi Medical Point İzmir Hastanesi, İzmir, , Turkey
Katip Celebi University Ataturk Research and Training Hospit, İzmir, , Turkey
Kocaeli University Research and Practice Hospital, Kocaeli, , Turkey
Necmettin Erbakan University Meram, Konya, , Turkey
Inonu University Turgut Ozal Medical Center, Malatya, , Turkey
Contact Details
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