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).
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;
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;
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Innovent Biologics, Inc.
Collaborator