NCT05468489

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

A Randomized, Open-label Study of Serplulimab Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Extensive Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Serplulimab + chemotherapy (carboplatin-etoposide)	Drug: Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. Drug: carboplatin and etoposide chemotherapeutics
DRUG	Atezolizumab + chemotherapy (carboplatin-etoposide)	Drug: Atezolizumab is a monoclonal antibody targeting PD-L1，developed by Roche Pharma AG. Drug: carboplatin and etoposide chemotherapeutics

Timeline

• Start date: 2022-11-18
• Primary completion: 2026-02-28
• Completion: 2027-12-31
• First posted: 2022-07-21
• Last updated: 2025-10-21

Locations

67 sites across 1 country: United States

Regulatory

• FDA-regulated drug study