Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-13 @ 11:00 PM
Study NCT ID:
NCT06612151
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2024-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer
Sponsor:
MediLink Therapeutics (Suzhou) Co., Ltd.
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: