Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.