RecruitingPhase 3NCT07739758

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

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

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Enrollment

442 participants

Start Date

Aug 18, 2026

Study Type

INTERVENTIONAL

Conditions

SCLC,Extensive Stage

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Carboplatin, a drug called Etoposide, and others for people with sclc,extensive stage. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGYL201

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,

DRUGSerplulimab

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.

DRUGCarboplatin

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.

DRUGEtoposide

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.

Locations(2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07739758

Related Trials

BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)

NCT07625644

Assessment of Adebelizumab Combined With Chemotherapy in Concurrent Radiotherapy Versus Sequential Radiotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

NCT06768307

A Study of Bemotuzumab Plus Chemotherapy and Anlotinib Induction Followed by Bemotuzumab, Anlotinib and Consolidative Thoracic Radiotherapy in Extensive-Stage Small Cell Lung Cancer

NCT073586761 location

Safety, Tolerability and Preliminary Efficacy of NEUK203-13 in Refractory Neuroendocrine Tumor Patients

NCT073666581 location

68Ga-PFD3 PET Imaging for the Diagnosis and Evaluation of Small Cell Lung Cancer

NCT075088521 location