Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Untreated Advanced Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- H101 combined with tirilizumab and platinum-containing two-drug chemotherapy
- description
- 1. Recombinant human adenovirus type 5 injection(H101), intratumoural, administered for 4 cycles, 1 injection on day 1 (d1) of each cycle.The number of injections should be determined according to the patient's tolerance and the ease of manipulation of the injection site, and should be no less than 2 times. 2. Tirilizumab injection, 200 mg, IV, d1, Q21d, administered until disease progression or intolerable side effects occur 3. Platinum-containing two-agent chemotherapy Adenocarcinoma: pemetrexed plus carboplatin Non-adenocarcinoma: paclitaxel/gemcitabine combined with carboplatin
- interventionNames
- Drug: Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy
Primary outcomes (1)
- measure
- The time from the date of first treatment to the first occurrence of disease progression or death from any cause, whichever event occurs first.
- timeFrame
- 1 year
- description
- Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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