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

20 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

442

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510060
        • Reclutamento
        • Sun Yat-sen University Cancer Center
        • Contatto:
          • Study Coordinator
    • Liaoning
      • Shenyang, Liaoning, Cina, 110042
        • Reclutamento
        • Liaoning Cancer Hospital & Institute
        • Contatto:
          • Study Coordinator

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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,

Altri nomi:
  • Tam-Peli
  • Tambotatug Pelitecan
Droga: 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.
Comparatore attivo: 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.
Droga: 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.

Droga: 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.

Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall survival (OS)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free survival (PFS) as assessed by investigator
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Up to approximately 30 months
PK parameters of YL201 and serplulimab will be evaluated.
Up to approximately 30 months
Anti-drug antibody (ADA)
Lasso di tempo: Up to approximately 30 months
Frequency of anti-YL201 antibody (ADA) will be investigated.
Up to approximately 30 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Collaboratori

Shanghai Henlius Biotech

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 agosto 2026

Completamento primario (Stimato)

1 giugno 2029

Completamento dello studio (Stimato)

1 aprile 2030

Date di iscrizione allo studio

Primo inviato

28 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 luglio 2026

Primo Inserito (Effettivo)

31 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TAISHAN-304

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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