Clinical trial NCT06136910: Oncorine (H101) Combined With Tislelizumab and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Untreated Advanced Non-small Cell Lung Cancer
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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 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.

Primary outcomes:
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
Secondary outcomes:
measure: Proportion of CR and PR in all patients.
timeFrame: 1 year
measure: Proportion of CR, PR and SD in all patients.
timeFrame: 1 year
measure: Safety statistics will be analysed for adverse events.
timeFrame: 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Liyun Miao, Doctor
role: STUDY_CHAIR
affiliation: The Second Attached Hospital Of Fujian Medical University
name: Dongyong Yang, Bachelor
role: STUDY_CHAIR
affiliation: MinDong Hospital of Ningde City
name: Jianhong Xiao, Bachelor
role: STUDY_CHAIR
affiliation: The Second Hospital of Zhangzhou
name: Minlin zheng, Bachelor
role: STUDY_CHAIR
References: