Combining Oncorine with Tislelizumab and Chemotherapy for Advanced 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 study is testing a new combination of a virus treatment, an immune therapy, and chemotherapy to see if it helps people with advanced lung cancer who haven't had other treatments yet.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Cancer Hospital (other gov)
• Drugs / interventions: tirelizumab, chemotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06136910 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination treatment involving recombinant human adenovirus type 5 (Oncorine), tirilizumab, and platinum-based chemotherapy in patients with untreated advanced non-small cell lung cancer (NSCLC) who do not have EGFR or ALK mutations. The study is divided into two phases, with Phase 1 focusing on a small group of patients to assess initial safety and efficacy, while Phase 2 aims to expand the sample size for a more comprehensive evaluation. Participants will receive the treatment and be monitored for progression-free survival, overall response rate, and disease control rate.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with untreated stage IV non-small cell lung cancer and no EGFR or ALK mutations.

Not a fit: Patients with small cell lung cancer components or severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced non-small cell lung cancer.

How similar studies have performed: While this approach is innovative, similar studies combining immunotherapy and chemotherapy have shown promise in other cancer types.

Eligibility 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.

Where this trial is running

Fuzhou, Fujian

• Fujian Cancer Hospital — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Study coordinator: Zhiyong He, Master

Conditions: Untreated Advanced Non-small Cell Lung Cancer