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

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).

Timeline

Start

2025-07-30

Primary completion

2027-08-01

Completion

2027-08-01

Publications

• Background Zugazagoitia J, Osma H, Baena J, Ucero AC, Paz-Ares L. Facts and Hopes on Cancer Immunotherapy for Small Cell Lung Cancer. Clin Cancer Res. 2024 Jul 15;30(14):2872-2883. doi: 10.1158/1078-0432.CCR-23-1159.
• Background Mei W, Faraj Tabrizi S, Godina C, Lovisa AF, Isaksson K, Jernstrom H, Tavazoie SF. A commonly inherited human PCSK9 germline variant drives breast cancer metastasis via LRP1 receptor. Cell. 2025 Jan 23;188(2):371-389.e28. doi: 10.1016/j.cell.2024.11.009. Epub 2024 Dec 9.
• Background Liu X, Bao X, Hu M, Chang H, Jiao M, Cheng J, Xie L, Huang Q, Li F, Li CY. Inhibition of PCSK9 potentiates immune checkpoint therapy for cancer. Nature. 2020 Dec;588(7839):693-698. doi: 10.1038/s41586-020-2911-7. Epub 2020 Nov 11.
• Background Ma S, He Z, Liu Y, Wang L, Yang S, Wu Y, Chen H, Wu Y, Wang Q. Sintilimab plus anlotinib as second or further-line therapy for extensive disease small cell lung cancer: a phase 2 investigator-initiated non-randomized controlled trial. EClinicalMedicine. 2024 Mar 14;70:102543. doi: 10.1016/j.eclinm.2024.102543. eCollection 2024 Apr.

Drugs

Indications