Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498479
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-06
Brief Title:
ARTEMIS-008HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer
Sponsor:
Hansoh BioMedical RD Company
Organization:
Hansoh BioMedical RD Company
Study Overview
Official Title:
ARTEMIS-008A Multicenter Randomized Open-label Phase 3 Study of HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The main objective of this study is to compare the efficacy of HS-20093 with standard of care SOC on prolonging overall survival OS in subjects with relapsed small cell lung cancer SCLC
Detailed Description:
This is a phase 3 randomized open-label multicenter study comparing HS-20093 with topotecan in patients with limited or extensive SCLC that had disease progression on or after first-line platinum-based regimen Subjects will be randomized by a ratio of 11 to receive HS-20093 or topotecan until disease progression
The primary objective of this study is to assess whether treatment with HS-20093 prolongs OS compared with treatment of topotecan among subjects with relapsed SCLC
The secondary objectives of the study are to further evaluate the efficacysafety of HS-20093 The exploratory objectives are to characterize the pharmacokinetics of HS-20093 evaluate E-R relationship immunogenicity of HS-20093 B7-H3 protein expression and soluble B7-H3 expression
The primary objective of this study is to assess whether treatment with HS-20093 prolongs OS compared with treatment of topotecan among subjects with relapsed SCLC
The secondary objectives of the study are to further evaluate the efficacysafety of HS-20093 The exploratory objectives are to characterize the pharmacokinetics of HS-20093 evaluate E-R relationship immunogenicity of HS-20093 B7-H3 protein expression and soluble B7-H3 expression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None