Examining gut microbiome diversity in patients with advanced lung cancer during treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.