drugset / Trial / NCT05468489

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

NCT05468489

Phase 3 Active not recruiting 200 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupOpen-labelTreatment

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)

Timeline

Start
2022-11-18
Primary completion
2026-02-28
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atezolizumab Monoclonal antibody
Subject Serplulimab Monoclonal antibody
Comparator Carboplatin Small molecule
Comparator Etoposide Small molecule