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)
研究单位：[1]Shanghai Junshi Bioscience Co., Ltd.[2]Banner MD Anderson Cancer Center,Goodyear,Arizona,United States,85338[3]Banner University Medical Center,Tucson,Arizona,United States,85713[4]Genesis Cancer and Blood Institute (Hot Springs, AR),Hot Springs,Arkansas,United States,05001[5]SCRI Nashville,Davis,California,United States,95616[6]Zangmeister Cancer Center (Columbus, OH),Los Angeles,California,United States,43219[7]Los Angeles Hematology Oncology,Los Angeles,California,United States,90033[8]University of Southern California Norris Comprehensive Cancer,Los Angeles,California,United States,90033[9]Florida Cancer Specialists Pan Handle,Fort Myers,Florida,United States,32310[10]Florida Cancer Specialists South,Fort Myers,Florida,United States,33908[11]USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N,Miami,Florida,United States,33173[12]Mid-Florida Hematology Oncology,Orange City,Florida,United States,55905[13]Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital,Marietta,Georgia,United States,30060[14]Norton Cancer Institute, Downtown, Multidisciplinary Clinic,Louisville,Kentucky,United States,40241[15]American Oncology Partners of Maryland, PA,Bethesda,Maryland,United States,20817[16]Dana Farber Cancer Institute-Hematology/Oncology,Boston,Massachusetts,United States,461099[17]Karmanos Cancer Center,Detroit,Michigan,United States,48201[18]Henry Ford Health System,Detroit,Michigan,United States,48202[19]Cancer and Hematology Centers of Western Michigan,Grand Rapids,Michigan,United States,49502[20]Washington University School of Medicine - Siteman Cancer Center,Saint Louis,Missouri,United States,63101[21]Dartmouth Hitchcock Medical Center,Lebanon,New Hampshire,United States,03756[22]Rutgers Cancer Institute of New Jersey,New Brunswick,New Jersey,United States,07101[23]North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists,New York,New York,United States,11776[24]University of Stony Brook,Stony Brook,New York,United States,11794[25]Toledo Clinic Cancer Center - Toledo,Toledo,Ohio,United States,97391[26]Oncology Associates Of Oregon, P.C.,Eugene,Oregon,United States,97401[27]Oregon Health and Science University,Portland,Oregon,United States,97239[28]Millennium Physicians - Oncology,Houston,Texas,United States,77090[29]Texas Oncology, P.A. - Oncology,Tyler,Texas,United States,97402[30]Virginia Cancer Specialists,Fairfax,Virginia,United States,22030[31]Algemeen Ziekenhuis Klina,Antwerpen,Belgium[32]Grand Hôpital de Charleroi - Site Notre-Dame,Charleroi,Belgium[33]AZ Groeningen,Kortrijk,Belgium[34]Jessa Ziekenhuis - Campus Virga Jesse,Limbourg,Belgium[35]CHU UCL Namur - Site Sainte-Elisabeth,Namur,Belgium[36]Harbin Medical University Cancer Hospital,Harbin,Heilongjiang,China[37]Xiangya Hospital Central South University,Changsha,Hunan,China[38]The Second Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China[39]The First Hospital of China Medical University,Shenyang,Liaoning,China[40]Shandong Cancer Hospital & Institute,Jinan,Shandong,China[41]Anyang Tumor Hospital,Anyang,China[42]Beijing Cancer Hospital,Beijing,China[43]Cancer Hospital Chinese Academy of Medical Sciences,Beijing,China[44]Jilin Cancer Hospital,Changchun,China[45]Hunan Cancer Hospital,Changsha,China[46]Sichuan cancer hospital,Chengdu,China[47]Chongqing University Cancer Hospital,Chongqing,China[48]Peking University Shenzhen Hospital,Guangdong,China[49]Sun Yat-sen University Cancer Center,Guangzhou,China[50]No. 1 Bandong Road, Gongshu District, Hangzhou,Hangzhou,China[51]The Second Affiliated Hospital Zhejiang University School of Medicine,Hangzhou,China[52]The First Affiliated Hospital of Ustc,Hefei,China[53]Henan Cancer Hospital,Henan,China[54]Affiliated Hospital of Jining Medical University,Jining,China[55]The First Affiliated Hospital of Nanchang University,Nanchang,China[56]The Second Affiliated Hospital of Nanchang University,Na
研究目的：
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.
