A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer
20. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
442
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: MediLink Study Team
- Telefonnummer: +86 512 62858368
- E-post: clinicaltrials@medilinkthera.com
Studiesteder
-
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Guangdong
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Guangzhou, Guangdong, Kina, 510060
- Rekruttering
- Sun Yat-sen University Cancer Center
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Ta kontakt med:
- Study Coordinator
-
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Liaoning
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Shenyang, Liaoning, Kina, 110042
- Rekruttering
- Liaoning Cancer Hospital & Institute
-
Ta kontakt med:
- Study Coordinator
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Any condition that, in the opinion of the investigator, would make the participant unsuitable for study participation.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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,
Andre navn:
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. |
|
Aktiv komparator: 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.
|
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 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. 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival (OS)
Tidsramme: 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
|
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Progression-free survival (PFS) as assessed by BIRC
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free survival (PFS) as assessed by investigator
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
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Pharmacokinetic (PK) characteristics
Tidsramme: Up to approximately 30 months
|
PK parameters of YL201 and serplulimab will be evaluated.
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Up to approximately 30 months
|
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Anti-drug antibody (ADA)
Tidsramme: Up to approximately 30 months
|
Frequency of anti-YL201 antibody (ADA) will be investigated.
|
Up to approximately 30 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. august 2026
Primær fullføring (Antatt)
1. juni 2029
Studiet fullført (Antatt)
1. april 2030
Datoer for studieregistrering
Først innsendt
28. juli 2026
Først innsendt som oppfylte QC-kriteriene
28. juli 2026
Først lagt ut (Faktiske)
31. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TAISHAN-304
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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