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Observational Study of Gut Microbiome in Advanced NSCLC

This study is looking at the variety and makeup of gut bacteria (your microbiome) in people with advanced or metastatic non-small cell lung cancer (NSCLC). Researchers want to see how your microbiome changes while you are receiving treatment for NSCLC, such as PD1 inhibitors (like pembrolizumab, nivolumab) or PDL1 inhibitors. You can join if you are at least 18 years old, have advanced/metastatic NSCLC, and are eligible for these treatments. The main goal is to understand your gut microbiome over a period of up to two years. This is an observational study, meaning researchers will collect information without giving you a new treatment.

Study design
This is an observational study with a planned enrollment of 82 participants. It is a pilot study collecting data.
What's involved
You would provide stool and saliva samples. The study will collect data on your gut microbiome for up to two years.
Compensation
Not stated in the trial record.
Follow-up
Your gut microbiome will be measured for up to two years.

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NCT06221800

Assess Diversity of Gut Microbiome in Met NSCLC in Correlation to Tx & Adverse Effects

Recruiting
Not specifiedAges 18+Observational
University of California, Irvine
~82 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:Microbiome

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Gut microbiomes in advanced/metastatic NSCLC patients
Measured over Up to 2 years

Conditions

Non Small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Misako Nagasaka, MD,PhD · PRINCIPAL_INVESTIGATOR · Chao Family Comprehensive Cancer Center

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Gut microbiomes in advanced/metastatic NSCLC patientsUp to 2 years

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