Examining gut microbiome diversity in patients with advanced lung cancer during treatment
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
This study is trying to see how the variety of gut bacteria in patients with advanced lung cancer affects their response to treatment and any side effects they might have.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Drugs / interventions | pembrolizumab, nivolumab, atezolizumab, durvalumab, chemotherapy |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06221800 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to collect data on the diversity and composition of gut microbiomes in patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) while they are undergoing treatment. The study will focus on patients receiving FDA-approved PD1 or PDL1 inhibitors, either alone or in combination with chemotherapy, as well as those on tyrosine kinase inhibitors. By analyzing the gut microbiome, researchers hope to understand its correlation with treatment responses and adverse effects experienced by patients. This study will help in identifying potential biomarkers that could influence treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with advanced or metastatic Non-Small Cell Lung Cancer who are eligible for specific cancer therapies.
Not a fit: Patients who are clinically unstable or unable to participate due to their health condition will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that improve outcomes for patients with advanced lung cancer.
How similar studies have performed: While the exploration of gut microbiome diversity in cancer treatment is a growing field, this specific approach in advanced NSCLC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Orange, California
- Chao Family Comprehensive Cancer Center University of California, Irvine — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: Misako Nagasaka, MD,PhD — Chao Family Comprehensive Cancer Center
- Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
- Email: ucstudy@uci.edu
- Phone: 1-877-827-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.