Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05837052
Status:
RECRUITING
Last Update Posted:
2023-07-17
First Post:
2023-04-17
Brief Title:
A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Therapy in NSCLC
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Treatment for Patients With Stage IIIB-IVA Oligometastatic Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2023-07
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 phase II single-arm study to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer
Detailed Description:
This single-arm open-label prospective phase II clinical trial was designed to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer
The primary endpoints were the rate of NSCLC converting to resectable tumors and the 1-year progression-free survival PFS rateThe secondary endpoints included the rates of R0 resection major pathological response MPR and pathological complete response pCR overall survival OS and PFS Multi-omics analysis will be performed to identify potential biomarkers for treatment response
The primary endpoints were the rate of NSCLC converting to resectable tumors and the 1-year progression-free survival PFS rateThe secondary endpoints included the rates of R0 resection major pathological response MPR and pathological complete response pCR overall survival OS and PFS Multi-omics analysis will be performed to identify potential biomarkers for treatment response
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