Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06241807
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-28
Brief Title:
Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC
Sponsor:
Shandong Cancer Hospital and Institute
Organization:
Shandong Cancer Hospital and Institute
Study Overview
Official Title:
A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
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 study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB T3-4N2 non-small cell lung cancer NSCLC patients Inclusion criteria are age 18-75 pathologically confirmed resectable stage IIIA-IIIB T3-4N2 NSCLC absence of EGFR ALK and ROS1 gene mutations and Eastern Cooperative Oncology Group ECOG status 0-1 All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy followed by curative surgery within 4-6 weeks after completion of chemotherapy Patients undergo 18F-fluorodeoxyglucose FDG PETCT scans in 1 week before treatment and 1 week before surgery and peripheral blood samples are collected for biomarker analysis The primary endpoints for follow-up are pathologic complete response pCR rate and major pathological response MPR rate while secondary endpoints include safety and progression-free survival Exploratory endpoints include molecular imaging research and biomarker analysis
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