A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer
20 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
442
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: MediLink Study Team
- Numéro de téléphone: +86 512 62858368
- E-mail: clinicaltrials@medilinkthera.com
Lieux d'étude
-
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Guangdong
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Guangzhou, Guangdong, Chine, 510060
- Recrutement
- Sun Yat-sen University Cancer Center
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Contact:
- Study Coordinator
-
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Liaoning
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Shenyang, Liaoning, Chine, 110042
- Recrutement
- Liaoning Cancer Hospital & Institute
-
Contact:
- Study Coordinator
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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,
Autres noms:
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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall survival (OS)
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-free survival (PFS) as assessed by investigator
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Up to approximately 30 months
|
TTR is defined as the time from randomization to the first documented objective response.
|
Up to approximately 30 months
|
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Treatment Emergent Adverse Event (TEAE)
Délai: 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
Délai: 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)
Délai: Up to approximately 30 months
|
Frequency of anti-YL201 antibody (ADA) will be investigated.
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Up to approximately 30 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 août 2026
Achèvement primaire (Estimé)
1 juin 2029
Achèvement de l'étude (Estimé)
1 avril 2030
Dates d'inscription aux études
Première soumission
28 juillet 2026
Première soumission répondant aux critères de contrôle qualité
28 juillet 2026
Première publication (Réel)
31 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TAISHAN-304
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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