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

20 augustus 2026 bijgewerkt door: MediLink Therapeutics (Suzhou) Co., Ltd.

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

442

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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,

Andere namen:
  • Tam-Peli
  • Tambotatug Pelitecan
Geneesmiddel: 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.
Actieve vergelijker: 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.
Geneesmiddel: 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.

Geneesmiddel: 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.

Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall survival (OS)
Tijdsspanne: 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.
Up to approximately 5 years
Progression-free survival (PFS) as assessed by BIRC
Tijdsspanne: 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.
Up to approximately 30 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-free survival (PFS) as assessed by investigator
Tijdsspanne: Up to approximately 30 months
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)
Tijdsspanne: Up to approximately 30 months
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)
Tijdsspanne: Up to approximately 30 months
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)
Tijdsspanne: Up to approximately 30 months
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)
Tijdsspanne: Up to approximately 30 months
TTR is defined as the time from randomization to the first documented objective response.
Up to approximately 30 months
Treatment Emergent Adverse Event (TEAE)
Tijdsspanne: Up to approximately 30 months

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
Tijdsspanne: Up to approximately 30 months
PK parameters of YL201 and serplulimab will be evaluated.
Up to approximately 30 months
Anti-drug antibody (ADA)
Tijdsspanne: Up to approximately 30 months
Frequency of anti-YL201 antibody (ADA) will be investigated.
Up to approximately 30 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Medewerkers

Shanghai Henlius Biotech

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 augustus 2026

Primaire voltooiing (Geschat)

1 juni 2029

Studie voltooiing (Geschat)

1 april 2030

Studieregistratiedata

Eerst ingediend

28 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 juli 2026

Eerst geplaatst (Werkelijk)

31 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

20 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TAISHAN-304

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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