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

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

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 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.

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.