RECRUITING Phase 2 ClinicalTrials.gov

Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine • ClinicalTrials.gov ID: NCT07061535

Registry updated: 2026-09-15

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Description

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).

Interventions

Tafolecimab (Drug)
Patients will receive Tafolecimab 300 mg every 3 weeks.
Sintilimab (approved) (Drug)
Patients will receive Sintilimab 200 mg every 3 weeks.
Etoposide (Drug)
Patients will recieve Etoposide (100 mg/m2) intravenously on days 1, 2, and 3 of each 3-week cycle.
Carboplatin / Cisplatin (Drug)
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.

Eligibility criteria

Key Inclusion Criteria: * 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). Key Exclusion Criteria: * 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.

Conditions

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

Locations

Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University — Changsha, Hunan, China
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science — Jinan, Shandong, China
Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences — Hangzhou, Zhejiang, China
First Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China
Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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