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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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,
• Препарат 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.
• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Overall survival (OS) [Срок оценки: Up to approximately 5 years]
• Progression-free survival (PFS) as assessed by BIRC [Срок оценки: Up to approximately 30 months]

Вторичные конечные точки (8)

• Progression-free survival (PFS) as assessed by investigator [Срок оценки: Up to approximately 30 months]
• Objective response rate (ORR) [Срок оценки: Up to approximately 30 months]
• Disease control rate (DCR) [Срок оценки: Up to approximately 30 months]
• Duration of response (DOR) [Срок оценки: Up to approximately 30 months]
• Time to response (TTR) [Срок оценки: Up to approximately 30 months]
• Treatment Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 30 months]
• Pharmacokinetic (PK) characteristics [Срок оценки: Up to approximately 30 months]
• Anti-drug antibody (ADA) [Срок оценки: Up to approximately 30 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Sun Yat-sen University Cancer Center — Гуанчжоу
• Liaoning Cancer Hospital & Institute — Шэньян

Идентификаторы

NCT: NCT07739758 · TAISHAN-304

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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