Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528847
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Adjuvant Benmelstobart for Stage IB Grade 3 Invasive Lung Adenocarcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Benmelstobart TQB2450 for Adjuvant Therapy in Pathologic Stage IB IASLC Grade 3 Invasive Lung Adenocarcinomas A Prospective Single-arm Phase 2 Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective single-arm phase 2 clinical trial assessing the feasibility efficacy and safety of the PD-L1 inhibitor Benmelstobart TQB2450 as an adjuvant therapy regimen in patients with pathologic stage IB IASLC grade 3 invasive lung adenocarcinoma without EGFR active mutations or ALK rearrangement
Detailed Description:
The target population for this study includes patients with pathologic stage IB IASLC grade 3 invasive lung adenocarcinoma without EGFR active mutations or ALK rearrangement who have undergone radical resection at Shanghai Pulmonary Hospital Patients are screened and enrolled within 4 to 12 weeks after surgery Following surgery adjuvant chemotherapy may be administered based on the patients treatment needs or the attending physicians assessment Subsequently patients will receive adjuvant immunotherapy with the PD-L1 inhibitor Benmelstobart TQB2450 injection at a dose of 1200 mg every 3 weeks by intravenous injection for a maximum of 16 cycles The primary endpoint is the 2-year disease-free survival DFS rate The secondary endpoints include the 3-year and 5-year DFS rates the 5-year overall survival OS rate and drug safety The sample size is 62 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None