clinical trial · NCT06612151
A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer (TAISHAN-302)
MediLink Therapeutics (Suzhou) Co., Ltd.·phase3·active not recruiting·n = 438
Small Cell Lung CancerYL201topotecan hydrochloride for injection
brief 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).
started
Dec 17, 2024
primary completion
Dec 1, 2027
completion
Dec 1, 2030
last updated
Sep 15, 2026
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.
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol