Recruiting

Gut Microbiome

Sponsor:

UCLA

Code:

NCT06221800

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Microbiome

Study Details

Brief 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.

Conditions

Non Small Cell Lung Cancer

Study ID

NCT06221800

Start date

Jan 31, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

82 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment with PD1/L1 monotherapy

Treatment with PD1/L1 + chemotherapy

Treatment with Tyrosine Kinase Inhibitor

Interventions

Microbiome

Stool and saliva samples will be collected

Primary outcome measure

  • Gut microbiomes in advanced/metastatic NSCLC patients [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-8839ucstudy@uci.edu

Locations

Chao Family Comprehensive Cancer Center University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Misako Nagasaka, MD, PhD

877-827-8839ucstudy@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-02-05.