Ignite Creation Date:
2024-07-17 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497530
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC
Sponsor:
Guangzhou Institute of Respiratory Disease
Organization:
Guangzhou Institute of Respiratory Disease
Study Overview
Official Title:
An Exploratory Study of Maintenance Lurbinectedin in Combination With Serplulimab for Patients With Extensive-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:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm open-lable exploratory study of Lurbinectedin in combination with Serplulimab as maintenance therapy in participants with extensive-stage small-cell lung cancer ES-SCLC after first-line induction therapy with carboplatin etoposide and Serplulimab The study consists of 2 phases an induction phase and a maintenance phase Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor RECIST v11 criteria after completion of 4 cycles of carboplatin etoposide and Serplulimab induction treatment in order to be considered for eligibility screening for the maintenance phase Eligible participants will receive lurbinectedin plus Serplulimab in the maintenance phase
Detailed Description:
None
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