Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-01-01 @ 2:58 PM
Study NCT ID:
NCT05740566
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2023-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT06064500
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
DeLLphi-304
Brief Summary:
The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: