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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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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/kexin 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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years, ECOG performance status 0-1;
• Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to Veterans Administration Lung Study Group criteria;
• Previously not receiving systemic treatment for ES-SCLC;
• Greater than or equal to 1 measurable lesion exists according to RECIST v1.1;
• Expected survival \>= 12 weeks;
• Adequate organ system functions (no blood transfusion or component blood use within 14 days before testing).
Locations
Other Locations
China
Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
NOT_YET_RECRUITING
Changsha
Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
RECRUITING
Hangzhou
First Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science
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/mL/min) or cisplatin (75 mg/m2) 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/m2) 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.