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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Untreated Advanced Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: H101 combined with tirilizumab and platinum-containing two-drug chemotherapy<br>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. Tirilizumab injection, 200 mg, IV, d1, Q21d, administered until disease progression or intolerable side effects occur Platinum-containing two-agent chemotherapy Adenocarcinoma: pemetrexed plus carboplatin Non-adenocarcinoma: paclitaxel/gemcitabine combined with carboplatin | Drug: Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy<br>* Recombinant human adenovirus type 5 injection : 21 days is one treatment cycle, in principle, 4 cycles of administration, 1 injection on day 1 (d1) of each cycle; the number of injections is determined according to the patient's tolerance and the ease of operation of the injection site, no less than 2 times. tirelizumab: 200mg intravenous, d1, Q21d, administered until disease progression or intolerable side effects occur platinum-containing two-drug chemotherapy: adenocarcinoma, pemetrexed combined with carboplatin, 4-6 cycles, d2, Q21d; non-adenocarcinoma, paclitaxel/gemcitabine combined with carboplatin, 4-6 cycles, d2, Q21d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time from the date of first treatment to the first occurrence of disease progression or death from any cause, whichever event occurs first. | Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of CR and PR in all patients. | Objective response rate: ORR | 1 year | 
| Proportion of CR, PR and SD in all patients. | Disease control rate: DCR | 1 year | 
| Safety statistics will be analysed for adverse events. | Safety statistics will be analysed for adverse events, including AEs, SAEs, drug-related AEs, AEs leading to dose adjustments, and AEs leading to withdrawal from the trial.All adverse events will also be rated based on the NCI CTCAE version 5.0, and AEs greater than or equal to grade 3 will be statistically summarised. | 1 year |