A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
YL201: YL201 will be administered by intravenous infusion at a dose of 2.0 mg/kg on Day 1 of each 3-week cycle. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first. The total number of treatment cycles of YL201 in this study is not fixed,
Serplulimab: Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 3-week cycle. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for serplulimab will be 2 years.
Carboplatin: Carboplatin will be administered by intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle. Carboplatin treatment will be administered for up to 4 cycles.
Etoposide: Etoposide will be administered by intravenous infusion at a dose of 100 mg/m2 on Days 1 to 3 of each 3-week cycle. Etoposide treatment will be administered for up to 4 cycles.
Study 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
Primary outcome measure(s)
- Overall survival (OS) — Up to approximately 5 years
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. OS was estimated using KM methodology. - Progression-free survival (PFS) as assessed by BIRC — Up to approximately 30 months
PFS, as assessed by Blinded Independent Review Committee (BIRC), is defined as the time from randomization to the first documented progressive disease (PD) based on BIRC imaging assessment, or death from any cause, whichever occurs first.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | Recruiting |
| Liaoning Cancer Hospital & Institute | Shenyang | Liaoning | Recruiting |
More MediLink Therapeutics (Suzhou) Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07739758 on ClinicalTrials.gov ↗ ← All trials in China