跳至主要内容
临床试验/NCT07191171
NCT07191171招募中不适用

Impact of Dysbiosis-inducing Drugs on Effectivity of Immune Checkpoint Inhibitor in Non-small Cell Lung Cancer Patients: a Retrospective Study

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2025年2月5日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
800
试验地点
1
主要终点
progression-free survival

研究概览

简要总结

Lung cancer is the leading cancer in France in terms of mortality. The prognosis of the disease is closely correlated with the diagnostic stage and the majority of patients are diagnosed at a metastatic stage. The arrival of immunotherapy has made it possible to change the therapeutic paradigm by significantly improving the survival of metastatic patients. Despite this progress, only 20 to 30% of patients respond to immunotherapy. The search for predictive factors of response to or resistance to these drugs is of major importance for better patient selection. Among these factors, the intestinal microbiota appears to be closely correlated with the response to immunotherapy via the education of adaptive anticancer immunity. Thus, several bacterial species have been associated with patient survival or disease progression. Interestingly, the abundance of these same bacteria can be modulated by certain drugs co-prescribed with immunotherapy. These dysbiotic treatments or those leading to a significant modification of the composition of the intestinal microbiota could then modulate the response to immunotherapy and therefore patient survival. The objective of this study is therefore to objectify the impact of several therapeutic classes modifying the intestinal microbiota initiated in the 90 days preceding D1 of immunotherapy on the survival of patients with locally advanced (stage III-C) or metastatic (stage IV) non-small cell lung cancer (NSCLC)

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (≥18 years)
  • Confirmed diagnosis of NSCLC
  • Stage IV or stage III-C NSCLC
  • Immunotherapy treatment

排除标准

  • Refusal to reuse data for scientific research purposes
  • Minor patient
  • Disease stage below stage III-C
  • Patient included in a clinical trial with an unknown randomization arm (double-blind study)
  • Lack of relevant data on concomitant treatments, biology, or clinical outcomes

结局指标

主要结局

progression-free survival

时间窗: 90 days preceding D1 of immunotherapy

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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