[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597672":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":36,"locations":42,"responsibleParty":104,"collaborators":106,"id":109,"slug":23,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":110,"sex":116,"minAge":117,"maxAge":23,"enrollmentInfo":118,"targetDuration":23,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":130,"overallStatus":63,"whyStopped":23,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tafolecimab + Sintilimab + Chemotherapy","EXPERIMENTAL","Eligible patients will receive 4 cycles of Tafolecimab (300 mg, sc, d1, Q3W) in combination with Sintilimab (200 mg, iv, d1, Q3W), along with etoposide and either carboplatin (AUC 5 mg\u002FmL\u002Fmin) or cisplatin (75 mg\u002Fm2) for up to 4 to 6 cycles. Subsequently, they will receive maintenance therapy with Sintilimab and Tafolecimab until disease progression, the occurrence of intolerable toxicities, or the completion of 2 years of treatment. Etoposide (100 mg\u002Fm2) will be administered intravenously on days 1, 2, and 3 of each 3-week cycle, while carboplatin or cisplatin will be given intravenously on day 1 of each 3-week cycle.",[13,14,15,16],"Drug: Tafolecimab","Drug: Sintilimab (approved)","Drug: Etoposide","Drug: Carboplatin \u002F Cisplatin",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Tafolecimab","Patients will receive Tafolecimab 300 mg every 3 weeks.",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Sintilimab (approved)","Patients will receive Sintilimab 200 mg every 3 weeks.",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Etoposide","Patients will recieve Etoposide (100 mg\u002Fm2) intravenously on days 1, 2, and 3 of each 3-week cycle.",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"Carboplatin \u002F Cisplatin","Patients will receive carboplatin (AUC 5 mg\u002FmL\u002Fmin) or cisplatin (75 mg\u002Fm2) intravenously on day 1 of each 3-week cycle for up to 4 to 6 cycles.",[9],[37],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},"Yang Xia, MD, PhD","CONTACT","+8618868439669","yxia@zju.edu.cn",[43,61,76,89,98],{"facility":44,"status":45,"city":46,"state":47,"zip":23,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hunan Cancer Hospital\u002Fthe Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University","NOT_YET_RECRUITING","Changsha","Hunan","China","CN",{"type":51,"coordinates":52},"Point",[53,54],112.97087,28.19874,{"lat":54,"lon":53},[57],{"name":58,"role":39,"phone":59,"phoneExt":23,"email":60},"Yongchang Zhang, MD, PhD","+8613873123436","zhangyongchang@csu.edu.cn",{"facility":62,"status":63,"city":64,"state":65,"zip":23,"country":48,"countryCode":49,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science","RECRUITING","Jinan","Shandong",{"type":51,"coordinates":67},[68,69],116.99722,36.66833,{"lat":69,"lon":68},[72],{"name":73,"role":39,"phone":74,"phoneExt":23,"email":75},"Xiangjiao Meng, MD, PhD","+8613793150996","mengxiangjiao@sina.com",{"facility":77,"status":63,"city":78,"state":79,"zip":23,"country":48,"countryCode":49,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences","Hangzhou","Zhejiang",{"type":51,"coordinates":81},[82,83],120.16142,30.29365,{"lat":83,"lon":82},[86],{"name":87,"role":39,"phone":23,"phoneExt":23,"email":88},"Jing Qin, MD, PhD","qinjing@zjcc.org.cn",{"facility":90,"status":63,"city":78,"state":79,"zip":23,"country":48,"countryCode":49,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"First Affiliated Hospital, School of Medicine, Zhejiang University",{"type":51,"coordinates":92},[82,83],{"lat":83,"lon":82},[95],{"name":96,"role":39,"phone":23,"phoneExt":23,"email":97},"Jian Ruan, MD, PhD","software233@zju.edu.cn",{"facility":5,"status":63,"city":78,"state":79,"zip":23,"country":48,"countryCode":49,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},{"type":51,"coordinates":100},[82,83],{"lat":83,"lon":82},[103],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},{"type":105,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[107],{"name":108,"class":6},"Innovent Biologics, Inc.","100597672",false,"NCT07061535","Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer","Efficacy and Safety of Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (STAR-SCLC)：A Prospective, Single Arm Trial","STAR-SCLC","Key Inclusion Criteria:\n\n* Age ≥18 years, ECOG performance status 0-1;\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to Veterans Administration Lung Study Group criteria;\n* Previously not receiving systemic treatment for ES-SCLC;\n* Greater than or equal to 1 measurable lesion exists according to RECIST v1.1;\n* Expected survival \\>= 12 weeks;\n* Adequate organ system functions (no blood transfusion or component blood use within 14 days before testing).\n\nKey Exclusion Criteria:\n\n* Previously receiving systemic anti-tumor therapy for ES-SCLC;\n* Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination;\n* Receiving other investigational drugs or participated in other interventional clinical studies within 4 weeks before signing the informed consent form;\n* Receiving systemic immunostimulant treatment within 4 weeks before enrollment;\n* Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed);\n* Severe cardiovascular disease;\n* Severe chronic\u002Factive infections requiring systemic antibacterial, antifungal or antiviral treatment within 2 weeks before enrollment;\n* Active hepatitis B virus (HBV)\u002F hepatitis C virus (HCV)\u002F human immunodeficiency virus (HIV) infection;\n* Active autoimmune diseases, a history of interstitial lung disease, or other uncontrolled systemic diseases;\n* Pregnancy or lactation;\n* Having a disease that requires systemic corticosteroids or other immunosuppressants to be treated within ≤14 days before enrollment;\n* Requiring at least monthly or more frequent drainage of pleural and\u002For pericardial or peritoneal effusion;\n* Using attenuated live vaccines, or planned to receive attenuated live vaccines within 28 days before enrollment;\n* Known to be allergic to Sintilimab or Tafolecimab or its excipients, having a history of severe allergic reaction to any monoclonal antibody, or having a history of allergy to cisplatin, carboplatin or etoposide;\n* Toxicity caused by previous anti-cancer treatment has not recovered to baseline or stable state at the time of enrollment;\n* Creatinine clearance rate \\\u003C 60 mL\u002Fmin (cisplatin) or \\\u003C 45 mL\u002Fmin (carboplatin)\n* Uncontrolled or symptomatic hypercalcemia.","ALL","18 Years",{"count":119,"type":120},40,"ESTIMATED","INTERVENTIONAL",[123],"PHASE2","This is a single arm, multi-center clinical trial. The goal of this clinical trial is to evaluate the efficacy, safety and biomarkers of Tafolecimab combined with Sintilimab and Chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). Tafolecimab is a recombinant fully humanized monoclonal antibody against proprotein convertase subtilisin\u002Fkexin type 9 (PCSK-9), which can reduce low-density lipoprotein-C levels and increase the expression level of major histocompatibility complex class I (MHC-I) on tumor cells. Sintilimab is a fully humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1).",[126,127,128,129],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)","Extensive Stage Lung Small Cell Cancer","Extensive-Stage Small-Cell Lung Cancer","Extensive Disease Small Cell Lung Cancer",[20,131,132,133,134],"Sintilimab","immunotherapy","PCSK9 inhibitor","SCLC","2026-06-22",{"date":137,"type":138},"2026-06-23","ACTUAL",{"date":140,"type":138},"2025-07-30",{"date":142,"type":120},"2027-08-01",{"name":5,"class":6},5]