Oncorine (H101) Combined With Tislelizumab and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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 EGFR/ALK negative. The study is divided into 2 phases.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Cancer Hospital

Criteria

Inclusion Criteria:

1. Fully informed about the study and voluntarily signed an informed consent form (ICF); ≥18 years and ≤75 years;

2. ECOG score 0-1;

3. non-small cell lung cancer (NSCLC) confirmed by histology or pathology;

4. stage IV on imaging assessment;

5. no EGFR or ALK gene mutations (genetic testing may not be performed in patients with squamous lung cancer);

6. no previous antitumour treatment for NSCLC No prior antitumour therapy for NSCLC;

7. lesions suitable for intratumour injection of drugs;

8. measurable or assessable lesions according to RECIST 1.1 criteria.

Exclusion Criteria:

1. histological or cytological pathology of the tumour confirms a combined small cell lung cancer component;

2. those with tests suggesting severe organ dysfunction;

3. subjects with any active, known or suspected autoimmune disease are excluded;

4. expected survival is less than 3 months.