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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The time from the date of first treatment to the first occurrence of disease progression or death from any cause, whichever event occurs first.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
H101 combined with tirilizumab and platinum-containing two-drug chemotherapy
- 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
干预措施: Recombinant human adenovirus type 5 injection (H101) combined with tirilizumab and platinum-containing two-drug chemotherapy (Drug)
结局指标
主要结局
The time from the date of first treatment to the first occurrence of disease progression or death from any cause, whichever event occurs first.
时间窗: 1 year
Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria
次要结局
- Proportion of CR and PR in all patients.(1 year)
- Proportion of CR, PR and SD in all patients.(1 year)
- Safety statistics will be analysed for adverse events.(1 year)