Ireland
--:--IST
Recruiting Phase 3

A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer

NCT07739758 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2026-08-18
Last updated
2026-08-24

Condition(s) studied

SCLC, Extensive Stage

Investigational drug(s) / intervention(s)

YL201 →Serplulimab →Carboplatin →Etoposide →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Voluntarily sign the written informed consent form and comply with the protocol requirements 2. Age ≥18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). 5. No prior systemic treatment for ES-SCLC. 6. At least one extracranial measurable lesion according to RECIST v1.1. 7. Adequate organ function. 8. Life expectancy ≥3 months. Exclusion Criteria: 1. Any histological types of transformed SCLC or combined SCLC. 2. History of immune-related adverse events (irAEs) of CTCAE Grade ≥3 during prior immunotherapy, or unresolved adverse events from previous antitumor therapy. 3. Major surgery (excluding diagnostic procedures) or severe trauma within 4 weeks prior to randomization or planned major surgery during the study period. 4. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 5. Presence of active brain metastases, brainstem metastases, or leptomeningeal metastases. 6. Presence of severe and uncontrolled cardiovascular or cerebrovascular disease. 7. History of interstitial lung disease (ILD) /pneumonitis requiring steroid treatment, or current diagnosis of ILD/pneumonitis, or concurrent pulmonary disease leading to clinically severe impairment of respiratory function. 8. Active autoimmune or inflammatory diseases within 2 years prior to randomization. 9. Severe infection within 4 weeks prior to randomization, or active infection requiring intravenous anti-infective therapy within 2 weeks or oral anti-infective therapy within 1 week prior to randomization. 10. Known active tuberculosis or active syphilis infection. 11. History of immunodeficiency or positive for human immunodeficiency virus (HIV) antibodies test. 12. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Participants with inactive HBV infection must receive antiviral therapy throughout the study. 13. History of other primary malignancies within 5 years prior to randomization. 14. Known hypersensitivity to any component of the investigational product. 15. Females who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study period. 16. Any condition that, in the opinion of the investigator, would make the participant unsuitable for study participation.

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)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Liaoning Cancer Hospital & Institute Shenyang Liaoning Recruiting
Official registry record

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