Clinical Trial

To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated October 21, 2025 (before its estimated February 28, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: * Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) * Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
Protocol Amendment History 25 amendments
This ClinicalTrials.gov record has been amended 25 times since 2022-07-19; most recent amendment 2025-10-20.
Status change: Recruiting → Active, Not Recruiting 2025-10-20
Status change: Not Yet Recruiting → Recruiting 2022-10-10
Trial Details
NCT Number NCT05468489
Lead Sponsor Shanghai Henlius Biotech
Conditions Extensive Stage Small Cell Lung Cancer
Enrollment 200 participants
Start Date 2022-11-18
Primary Completion 2026-02-28 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-21