Status:
UNKNOWN
Oncorine (H101) Combined With Tislelizumab and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Untreated Advanced Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 du...
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 s...
Eligibility Criteria
Inclusion
- Fully informed about the study and voluntarily signed an informed consent form (ICF); ≥18 years and ≤75 years;
- ECOG score 0-1;
- non-small cell lung cancer (NSCLC) confirmed by histology or pathology;
- stage IV on imaging assessment;
- no EGFR or ALK gene mutations (genetic testing may not be performed in patients with squamous lung cancer);
- no previous antitumour treatment for NSCLC No prior antitumour therapy for NSCLC;
- lesions suitable for intratumour injection of drugs;
- measurable or assessable lesions according to RECIST 1.1 criteria.
Exclusion
- histological or cytological pathology of the tumour confirms a combined small cell lung cancer component;
- those with tests suggesting severe organ dysfunction;
- subjects with any active, known or suspected autoimmune disease are excluded;
- expected survival is less than 3 months.
Key Trial Info
Start Date :
May 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06136910
Start Date
May 9 2023
End Date
December 31 2025
Last Update
November 18 2023
Active Locations (1)
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1
Fujian Cancer Hospital
Fuzhou, Fujian, China