Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478043
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-21
Brief Title:
A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for ES-SCLC
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
Phase II Study of AK112 Combined With Irinotecan Liposome in Patients With ES-SCLC Who Progressed on Immune Checkpoint Inhibitors and Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 single-arm prospective phase 2 study evaluating the efficacy and safety of ivonescimab combined with irinotecan liposome for relapsed extensive stage small cell lung cancer who progressed on PD-L1 -based first-line therapy
Detailed Description:
Patients will receive ivonescimab at 20mgkg intravenously on days 1 of every 21-day cycle and irinotecan liposome 565mgm2 intravenously on days 1 of every 14-day cycle Treatment will be discontnued in case of until the toxicity became intolerable the investigator determined that there was no further clinical benefit based on a combination of RECIST V11 imaging assessment and clinical status 24 months of treatment was completed or the study was withdrawn for other reasons
Study Oversight
Has Oversight DMC:
None
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?:
None