Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 11:29 AM
Study NCT ID:
NCT06332950
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in ES-SCLC Pre-treated With Immunotherapy
Sponsor:
Baohui Han
Organization:
Study Overview
Official Title:
A Randomized, Multi-cohort, Multi-center Phase Ib/II Study of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in Patients With ES-SCLC Pre-treated With Immune Checkpoint Inhibitor(s)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s).
Detailed Description:
This study is divided into two stages. Dose exploration will be conducted first, and after obtaining preliminary safety data it will be decided by investigator when to proceed with dose extension. The aim of this study is to observe and evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib.
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?:
None
Is an FDA AA801 Violation?: