EXL01 in Combination With Nivolumab for Advanced NSCLC Refractory to Immunotherapy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Progression-free survival rate (PFS Rate) for the assessment of efficacy, defined as the rate of alive and non-progressive subjects as per iRECIST 1.1 over the study subjects.
研究概览
简要总结
As treatment options are limited following progression on anti PD-(L)1 and platinum-based chemotherapy, we propose this trial for patients who have failed to respond or have shown intolerance to standard therapies or for whom no appropriate therapies are known to provide clinical benefit. Considering the strong therapeutic rationale of an association between antineoplastic immunotherapy and EXL01 (single-strain of F. prausnitzii, a bacteria which is a dominant member of the healthy gut microbiota), we propose to assess this combination for NSCLC treatment. This is a pilot, Phase I/II, one-arm, monocentric study evaluating the combination of EXL01 with nivolumab treatment for Non-Small Cell Lung Cancer patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
EXL01 + Nivolumab
干预措施: EXL01 (Drug)
结局指标
主要结局
Progression-free survival rate (PFS Rate) for the assessment of efficacy, defined as the rate of alive and non-progressive subjects as per iRECIST 1.1 over the study subjects.
时间窗: At 3 months from the inclusion
次要结局
- Progression Free Survival, defined as the time from inclusion to the first documented disease progression or death due to any cause, whichever occurs first.(First 6 weeks of treatment)
- ORR (Overall Response Rate) as per iRECIST1.1 for the assessment of efficacy, defined as the rate of confirmed Complete Response (CR) or Partial Response (PR) over the study subjects efficacy responses.(First 6 weeks of treatment)
- Overall Survival, defined as the time from inclusion to the date of death due to any cause(First 6 weeks of treatment)
- Disease Control Rate, defined as the rate of confirmed Complete Response (CR), or Partial Response (PR), or Stable Disease (SD) over the study subjects efficacy responses(First 6 weeks of treatment)
- Number of Grade ≥ 3 treatment-related AEs, using CTCAE(First 6 weeks of treatment)