A Pilot Study to Assess the Diversity of Gut Microbiome in Metastatic Non-Small Cell Lung Cancer (NSCLC) in Correlation to Treatment Effects and Adverse Effects

University of California, Irvine1 个研究点分布在 1 个国家目标入组 82 人2024年1月31日

适应症Non Small Cell Lung Cancer

干预措施Microbiome

概览

阶段: 不适用
干预措施: Microbiome
疾病 / 适应症: Non Small Cell Lung Cancer
发起方: University of California, Irvine
入组人数: 82
试验地点: 1
主要终点: Gut microbiomes in advanced/metastatic NSCLC patients
状态: 招募中
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验相关资讯

概览

简要总结

This is a pilot study collecting data on the diversity and composition of gut microbiomes in subjects with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) while receiving treatment for NSCLC.

注册库

clinicaltrials.gov

开始日期

2024年1月31日

结束日期

2026年12月1日

最后更新

2个月前

研究类型

Observational

性别

All

研究者

发起方

University of California, Irvine

责任方

Principal Investigator

主要研究者

Misako Nagasaka

Associate Clinical Professor

University of California, Irvine

入排标准

入选标准

•1\. Advanced/Metastatic non-small cell lung cancer NSCLC patients.
•2\. The patient himself/herself must be 18 years of age on day of signing informed consent.
•3\. The subject has signed the informed consent form.
•4\. The patient must be eligible to receive FDA approved and non-approved PD1 inhibitors (i.e. pembrolizumab, nivolumab) or PDL1 inhibitor (i.e. atezolizumab, durvalumab) either single agent or as combination therapy with chemotherapy, or be eligible to receive FDA approved and non-approved tyrosine kinase inhibitors.
•5\. The subject will be registered upon submission of the samples. When submitted on separate dates, the submission occurring later will be considered the date of registration

排除标准

•1\. Those subjects who are determined clinically unstable of the participation of this study as determined by the PI or treating physician will be excluded and asked to focus on their treatment.

研究组 & 干预措施

Treatment with PD1/L1 monotherapy

干预措施: Microbiome

Treatment with PD1/L1 + chemotherapy

干预措施: Microbiome

Treatment with Tyrosine Kinase Inhibitor

干预措施: Microbiome

结局指标

主要结局

Gut microbiomes in advanced/metastatic NSCLC patients

时间窗: Up to 2 years

To summarize the diversity and composition of gut microbiomes at baseline or prior to initiation of therapy

次要结局

Change in microbiome diversity and composition from baseline (prior to start of therapy) to first post-treatment evaluation scan.(Up to 2 years)
Progression-Free Survival (PFS)(Up to 2 years)
Overall survival (OS)(Up to 2 years)
Clinical Response Rate (RR)(Up to 2 years)