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

Official title

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

Overview

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.

Interventions

• Drug 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,
• Drug 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.
• Drug 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.
• Drug 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.

Primary outcome measures

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

Secondary outcome measures (8)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• Sun Yat-sen University Cancer Center — Guangzhou
• Liaoning Cancer Hospital & Institute — Shenyang

Identifiers

NCT: NCT07739758 · TAISHAN-304

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗