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

NCT07739758 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: TAISHAN-304
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

SCLC, Extensive Stage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Progression-free survival (PFS) as assessed by investigator

  Up to approximately 30 months

• Objective response rate (ORR)

  Up to approximately 30 months

• Disease control rate (DCR)

  Up to approximately 30 months

• Duration of response (DOR)

  Up to approximately 30 months

• Time to response (TTR)

  Up to approximately 30 months

Study Arms (2)

YL201 in combination with serplulimab

EXPERIMENTAL

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; Drug: Serplulimab

Carboplatin and etoposide in combination with serplulimab

ACTIVE COMPARATOR

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; Drug: Carboplatin; Drug: Etoposide

Interventions

YL201 DRUG

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,

Also known as: Tam-Peli, Tambotatug Pelitecan

YL201 in combination with serplulimab

Serplulimab DRUG

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 and etoposide in combination with serplulimab; YL201 in combination with serplulimab

Carboplatin DRUG

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.

Carboplatin and etoposide in combination with serplulimab

Etoposide DRUG

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.

Carboplatin and etoposide in combination with serplulimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any histological types of transformed SCLC or combined SCLC.
• History of immune-related adverse events (irAEs) of CTCAE Grade ≥3 during prior immunotherapy, or unresolved adverse events from previous antitumor therapy.
• Major surgery (excluding diagnostic procedures) or severe trauma within 4 weeks prior to randomization or planned major surgery during the study period.
• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Presence of active brain metastases, brainstem metastases, or leptomeningeal metastases.
• Presence of severe and uncontrolled cardiovascular or cerebrovascular disease.
• 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.
• Active autoimmune or inflammatory diseases within 2 years prior to randomization.
• 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.
• Known active tuberculosis or active syphilis infection.
• History of immunodeficiency or positive for human immunodeficiency virus (HIV) antibodies test.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Participants with inactive HBV infection must receive antiviral therapy throughout the study.
• History of other primary malignancies within 5 years prior to randomization.
• Known hypersensitivity to any component of the investigational product.
• Females who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study period.

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead
• Shanghai Henlius Biotech: collaborator

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110042, China

Location

MeSH Terms

Interventions

Carboplatin; Etoposide

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

MediLink Study Team

CONTACT

+86 512 62858368; clinicaltrials@medilinkthera.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

CN (2)