A Study of Carboplatin Plus Etoposide With or Without ZKAB001 (Anti-PD-L1 Antibody) in Patients With ES-SCLC

Summary

This is a randomized, Phase III, multicenter, double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of ZKAB001 in combination with carboplatin + etoposide compared with treatment with placebo + carboplatin + etoposide in patients who have ES-SCLC and are untreated for their extensive-stage disease.

Timeline

Start

2021-07-15

Primary completion

2023-10-13

Completion

2023-10-13

Publications

• Chen Z, Chen J, Huang D, Zhang W, Wu L, Yi T, Wang Q, Han L, Tan L, Li Y, Zhang Z, Li N, Li J, Zhang T, Hu Y, Sun H, Wu Y, He Z, Yang R, Cheng P, Li X, Shi J, Yu G, Ma D, Li BX, Dai X, Wong M, Li Y, Yu X, Lu S; Socazolimab Study Group. A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer. Signal Transduct Target Ther. 2025 Jan 13;10(1):28. doi: 10.1038/s41392-024-02115-5.
• Lu S, Chen Z, Cui J, Guo R, Li Z, Li BX, Dai X. Efficacy and Safety of Anti-Programmed Death-Ligand 1 Monoclonal Antibody Socazolimab With Carboplatin and Etoposide for Extensive-Stage SCLC: Results From the Phase 1b Clinical Trial. JTO Clin Res Rep. 2023 Feb 28;4(4):100478. doi: 10.1016/j.jtocrr.2023.100478. eCollection 2023 Apr.

Drugs

Indications