To Evaluate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open-label study of HLX10 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 (HLX10): HLX10 + chemotherapy (carboplatin-etoposide)

• Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Henlius Biotech
• Treatments: Atezolizumab; Carboplatin; Etoposide; Etoposide phosphate

Criteria

Inclusion Criteria:

Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).

No prior systemic therapy for ES-SCLC.

Major organs are functioning well.

Participant must keep contraception.

Exclusion Criteria:

Histologically or cytologically confirmed mixed SCLC.

Known history of severe allergy to any monoclonal antibody.

Known hypersensitivity to carboplatin or etoposide.

Pregnant or breastfeeding females.

Patients with a known history of psychotropic drug abuse or drug addiction.

Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.