Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467500
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-16
Brief Title:
A Prospective Open-label Single-center Single-arm Phase II Clinical Study of Cadonilimab AK104 Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer With Negative Driver Genes and Failed Immunotherapy
Sponsor:
Xin-Hua Xu
Organization:
China Three Gorges University Yichang China
Study Overview
Official Title:
A Prospective Open-label Single-center Single-arm Phase II Clinical Study of Cadonilimab AK104 Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer NSCLC With Negative Driver Genes and Failed Immunotherapy
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The aim of evaluating the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in patients with advanced non-small cell lung cancer NSCLC with negative driver genes who have failed previous immunotherapy is to provide a more effective and safe treatment option for these patients
Detailed Description:
Cadonilimab AK104 Chinas first globally developed bispecific antibody targeting both PD-1 and CTLA-4 has demonstrated manageable safety and promising anti-tumor activity in female cervical cancer esophageal squamous cell carcinoma and hepatocellular carcinoma However there is currently no available data on the efficacy and safety of cadonilimab combined with monotherapy chemotherapy for treating advanced non-small cell lung cancer NSCLC with negative driver genes and previous immunotherapy failure Therefore this study aims to prospectively and openly evaluate the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in treating patients with advanced NSCLC with negative driver genes and previous immunotherapy failure using a single-arm trial design The goal is to provide a more effective and safe treatment option for these patients
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