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

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.

Study Overview

• Status: Recruiting
• Conditions: SCLC, Extensive Stage
• Intervention / Treatment: Drug: YL201; Drug: Serplulimab; Drug: Carboplatin; Drug: Etoposide

• Study Type: Interventional
• Enrollment (Estimated): 442
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: MediLink Study Team; Phone Number: +86 512 62858368; Email: clinicaltrials@medilinkthera.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Study Coordinator
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Recruiting
      • Liaoning Cancer Hospital & Institute
      • Contact: Study Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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,; Other Names: Tam-Peli; Tambotatug Pelitecan; Drug: 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.
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.	Drug: 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.; Drug: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	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.	Up to approximately 5 years
Progression-free survival (PFS) as assessed by BIRC	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.	Up to approximately 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) as assessed by investigator	PFS assessed by investigator is defined as the time from randomization to the first documented PD based on investigator assessment, or death from any cause, whichever occurs first.	Up to approximately 30 months
Objective response rate (ORR)	ORR is defined as the percentage of participants with (confirmed) complete response or partial response as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to approximately 30 months
Disease control rate (DCR)	DCR is defined as the percentage of participants with (confirmed) complete response, partial response, or stable disease as assessed according to RECIST v1.1	Up to approximately 30 months
Duration of response (DOR)	DOR is defined as the time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.	Up to approximately 30 months
Time to response (TTR)	TTR is defined as the time from randomization to the first documented objective response.	Up to approximately 30 months
Treatment Emergent Adverse Event (TEAE)	Treatment-emergent adverse events (TEAEs) are defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new onset or worsening) that occurs after initiation of YL201, or any worsening of a pre-existing condition during YL201 treatment. TEAEs will be graded and summarized by type, frequency, and severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0.	Up to approximately 30 months
Pharmacokinetic (PK) characteristics	PK parameters of YL201 and serplulimab will be evaluated.	Up to approximately 30 months
Anti-drug antibody (ADA)	Frequency of anti-YL201 antibody (ADA) will be investigated.	Up to approximately 30 months

Collaborators and Investigators

• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
• Collaborators: Shanghai Henlius Biotech

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: July 28, 2026
• First Submitted That Met QC Criteria: July 28, 2026
• First Posted (Actual): July 31, 2026

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 20, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Coordination Complexes; Etoposide; Carboplatin
• Other Study ID Numbers: TAISHAN-304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No