Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526624
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ARTEMIS-009 A Phase 3 Randomized Controlled Multi-center Open-label Study of HS-20093 Versus Active Surveillance As Consolidation Therapy After Chemoradiotherapy in Subjects With Limited-Stage Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the efficacy safety and tolerability of HS-20093 compared with active surveillance as consolidation therapy after chemoradiotherapy in participants with limited-stage small cell lung cancer
Detailed Description:
This is a randomized controlled open-label multi-center phase III clinical study to evaluate the efficacy and safety of HS-20093 versus active surveillance as consolidation therapy in participants with limited-stage small cell lung cancer LS-SCLC who have not progressed after receiving chemoradiotherapy CRT
This study consists of an experimental arm and a control arm The experimental arm will be administered HS-20093 and the control arm will only receive active surveillance Efficacy and safety were assessed in both arms by follow-up analyses
This study consists of an experimental arm and a control arm The experimental arm will be administered HS-20093 and the control arm will only receive active surveillance Efficacy and safety were assessed in both arms by follow-up analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None