Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingObservational

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

NCT ID: NCT06221800Sponsor: University of California, IrvineLast updated: 2026-02-05

Summary

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.

Arms & interventions

  • Diagnostic TestMicrobiome

    Stool and saliva samples will be collected

Outcome measures

Primary

  • Gut microbiomes in advanced/metastatic NSCLC patients

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

    Time frame: Up to 2 years

Secondary

  • Change in microbiome diversity and composition from baseline (prior to start of therapy) to first post-treatment evaluation scan.

    Time frame: Up to 2 years

  • Clinical Response Rate (RR)

    Time frame: Up to 2 years

  • Progression-Free Survival (PFS)

    Time frame: Up to 2 years

  • Overall survival (OS)

    Time frame: Up to 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (1)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868

Recruiting
Misako Nagasaka, MD, PhD · Contact
Assess Diversity of Gut Microbiome in Met NSCLC in Correlation to Tx & Adverse Effects | Cancerify