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

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).

NCT Number	NCT07061535
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University Collaborators: Innovent Biologics, Inc.
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
Enrollment	40 participants
Start Date	2025-07-30
Primary Completion	2027-08-01 (estimated)
Study Completion	2027-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-23