Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136910
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-07
Brief Title:
Oncorine H101 Combined With Tislelizumab and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer
Sponsor:
Fujian Cancer Hospital
Organization:
Fujian Cancer Hospital
Study Overview
Official Title:
Oncorine H101 Combined With Tislelizumab and Platinum-based Two-drug Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer a Phase II Single-arm Clinical Trail
Status:
RECRUITING
Status Verified Date:
2023-11
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 is a single-arm single-centre phase II study to evaluate the efficacy PFS ORR DCR and safety of recombinant human adenovirus type 5 in combination with tirelizumab and platinum-containing dual-agent chemotherapy in previously untreated patients with advanced non-small cell lung cancer who are EGFRALK negative The study is divided into 2 phases
Detailed Description:
Phase 1 is a preliminary exploration of safety and efficacy The safety and efficacy of the regimen was assessed in the 10 patients enrolled for interim analysis Phase 2 will continue to expand the sample size to assess the efficacy and safety of the regimen with 20 patients planned to be enrolled
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?:
False
Is an FDA AA801 Violation?:
None