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
Second Affiliated Hospital, School of Medicine, Zhejiang University
40 participants
Jul 30, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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).
Exclusion Criteria17
- Previously receiving systemic anti-tumor therapy for ES-SCLC;
- Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination;
- Receiving other investigational drugs or participated in other interventional clinical studies within 4 weeks before signing the informed consent form;
- Receiving systemic immunostimulant treatment within 4 weeks before enrollment;
- Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed);
- Severe cardiovascular disease;
- Severe chronic/active infections requiring systemic antibacterial, antifungal or antiviral treatment within 2 weeks before enrollment;
- Active hepatitis B virus (HBV)/ hepatitis C virus (HCV)/ human immunodeficiency virus (HIV) infection;
- Active autoimmune diseases, a history of interstitial lung disease, or other uncontrolled systemic diseases;
- Pregnancy or lactation;
- Having a disease that requires systemic corticosteroids or other immunosuppressants to be treated within ≤14 days before enrollment;
- Requiring at least monthly or more frequent drainage of pleural and/or pericardial or peritoneal effusion;
- Using attenuated live vaccines, or planned to receive attenuated live vaccines within 28 days before enrollment;
- 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;
- Toxicity caused by previous anti-cancer treatment has not recovered to baseline or stable state at the time of enrollment;
- Creatinine clearance rate < 60 mL/min (cisplatin) or < 45 mL/min (carboplatin)
- Uncontrolled or symptomatic hypercalcemia.
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Interventions
Patients will receive Tafolecimab 300 mg every 3 weeks.
Patients will receive Sintilimab 200 mg every 3 weeks.
Patients will recieve Etoposide (100 mg/m2) intravenously on days 1, 2, and 3 of each 3-week cycle.
Patients will receive carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) intravenously on day 1 of each 3-week cycle for up to 4 to 6 cycles.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07061535