Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485544
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-20
Brief Title:
Neoadjuvant Adebrelimab in Resectable SCLC A Randomized Trial
Sponsor:
Tang-Du Hospital
Organization:
Tang-Du Hospital
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial of Neoadjuvant Adebrelimab Combined With Chemotherapy for Resectable Small Cell Lung Cancer SCLC
Status:
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 study is a randomized open-label multicenter exploratory research aiming to evaluate the efficacy and safety of Adebrelimab in combination with chemotherapy etoposide and platinum-based therapy as neoadjuvant treatment for resectable stage I-IIIB stage IIIB limited to T1-4N1-2M0 small cell lung cancer SCLC The study is primarily conducted at Tangdu Hospital of the Fourth Military Medical University A total of 104 patients with stage IA-IIIB SCLC stage IIIB limited to T1-4N1-2M0 will be enrolled and randomized 11 to receive either Adebrelimab plus chemotherapy or chemotherapy alone Each patient will undergo 3 cycles of study treatment followed by a 3-4 week break before surgery Treatment will be discontinued if patients experience disease progression intolerable drug-related adverse events withdrawal of informed consent or other specified conditions during the study Effectiveness and safety outcomes will be monitored throughout the trial The primary objective is to evaluate pathological complete response pCR with Adebrelimab combination therapy Secondary objectives include assessing event-free survival EFS major pathological response mPR objective response rate ORR disease-free survival DFS and safety
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