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A Phase III, Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of YL201 in Combination With Serplulimab Versus Carboplatin and Etoposide in Combination With Serplulimab as First-line Treatment in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of YL201 in combination with serplulimab versus standard-of-care carboplatin and etoposide in combination with serplulimab as first-line treatment in patients with extensive-stage small cell lung cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Voluntarily sign the written informed consent form and comply with the protocol requirements
• Age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
• No prior systemic treatment for ES-SCLC.
• At least one extracranial measurable lesion according to RECIST v1.1.
• Adequate organ function.
• Life expectancy ≥3 months.
Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Liaoning Cancer Hospital & Institute
RECRUITING
Shenyang
Contact Information
Primary
MediLink Study Team
clinicaltrials@medilinkthera.com
+86 512 62858368
Time Frame
Start Date:2026-08-18
Estimated Completion Date:2030-04
Participants
Target number of participants:442
Treatments
Experimental: YL201 in combination with serplulimab
Participants will receive YL201 in combination with serplulimab until disease progression or unacceptable toxicity, whichever occurs first. The total number of treatment cycles of YL201 in this study is not fixed, and the maximum duration of serplulimab treatment is 2 years.
Active_comparator: Carboplatin and etoposide in combination with serplulimab
Participants will receive 4 cycles of carboplatin plus etoposide in combination with serplulimab as induction therapy, followed by maintenance treatment with serplulimab for up to 2 years.