NCT04636775招募中不适用
Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)
Jun Zhang, MD, PhD3 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年7月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Microbiome difference between patients with and without AEs>=grade 3
研究概览
简要总结
This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. In addition, the investigator will look into microbiome changing modifiers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Must have tumor tissue biopsy-proven to be NSCLC
- •Must have a target lesion to evaluate treatment response
- •Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients
- •Will receive single agent anti-PD-1/PD-L1 therapy (e.g. pembrolizumab, nivolumab, atezolizumab, avelumab or durvalumab, etc.). Patients can be on other interventional trial if they will be receiving single agent anti-PD-1/PD-L1
排除标准
- •Prior treatment with any forms of cancer immunotherapy
- •Not competent to make medical decision, noncommunicative or noncompliant per treating physician's judgement
- •Not English-speaking
- •Patients that are pregnant
- •Prisoners
- •Students and employees
- •Psychiatric illness/social situations that would limit compliance with study requirements
结局指标
主要结局
Microbiome difference between patients with and without AEs>=grade 3
时间窗: Through study completion, an average of 1 year
Adverse events (AEs) will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
次要结局
- Microbiome difference between responders vs. nonresponders(Through study completion, an average of 1 year)
- Correlation of microbiome to tumor tissue PD-L1 expression(Through study completion, an average of 1 year)
- Correlation of microbiome to diet(Through study completion, an average of 1 year)
研究者
Jun Zhang, MD, PhD
Associate Professor; Principal Investigator
University of Kansas Medical Center
研究点 (3)
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