NCT06612151

A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer

A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Compare the Efficacy and Safety of YL201 Versus Topotecan Hydrochloride in Subjects with Relapsed Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 438 (estimated)
• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to compare the efficacy and safety of YL201 with Topotecan Hydrochloride in subjects with relapsed small cell lung cancer (SCLC).

Detailed description

The primary objective of this study is to assess whether treatment with YL201 prolongs overall survival (OS) compared with treatment of topotecan hydrochloride among subjects with relapsed SCLC. The secondary objectives of the study are to further evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YL201, and the correlation between B7-H3 expression level and the efficacy of YL201.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	YL201	Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle at RP3D dose level.
DRUG	topotecan hydrochloride for injection	Topotecan hydrochloride will be administered intravenously per prescribing information.

Timeline

• Start date: 2024-12-17
• Primary completion: 2027-12-01
• Completion: 2030-12-01
• First posted: 2024-09-25
• Last updated: 2025-02-11

Locations

1 site across 1 country: China