Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424821
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-12
Brief Title:
Cadonilimab Plus Chemotherapy as First-line Treatment for PD-L1 Negative NSCLC
Sponsor:
Shanghai Pulmonary Hospital Shanghai China
Organization:
Shanghai Pulmonary Hospital Shanghai China
Study Overview
Official Title:
A Phase II Clinical Study of Cadonilimab in Combination With Chemotherapy as First-Line Treatment for PD-L1 Negative Advanced Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
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:
LungCadX
Brief Summary:
The goal of this clinical trial is to investigate the efficacy safety and tolerability of PD-1CTLA-4 inhibitor Cadonilimab combination with chemotherapy as first-line treatment for PD-L1 negative advanced non small cell lung cancer patients And also explore the potential biomarkers for predicting the efficacy of PD-1CTLA-4 inhibitor for advanced non small cell lung cancer
Detailed Description:
LungCadX is a multi-center open-label single-arm investigator initiated phase Ⅱ study Patients received cadonilimab 10 mgkg IV every 3 weeks plus platinum-based chemotherapy carboplatin area under the curve AUC 5 mgmL per min IV and paclitaxel 175 mgm2 IV for squamous NSCLC or carboplatin AUC 5 mgmL per min IV and pemetrexed 500 mgm2 IV for non-squamous NSCLC for up to four cycles followed by maintenance therapy with cadonilimab for squamous NSCLC and intravenous cadonilimab plus pemetrexed for non-squamous NSCLC The primary endpoint was 12-month PFS rate by investigator assessment per RECIST 11 Secondary endpoints included PFS OS ORRDoRDCR and the safety Exploratory objective was to assess bloodtumorurinefaeces tissue for potential biomarkers study Adverse events will be monitored throughout the trial and graded according to the CTCAE v50
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