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

NCT06221800 | Recruiting

• 2 other identifiers: 3887UCI 22-86
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Gut microbiomes in advanced/metastatic NSCLC patients

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

  Up to 2 years

Secondary Outcomes (4)

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

  Up to 2 years

• Clinical Response Rate (RR)

  Up to 2 years

• Progression-Free Survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (3)

Treatment with PD1/L1 monotherapy

Diagnostic Test: Microbiome

Treatment with PD1/L1 + chemotherapy

Diagnostic Test: Microbiome

Treatment with Tyrosine Kinase Inhibitor

Diagnostic Test: Microbiome

Interventions

Microbiome DIAGNOSTIC_TEST

Stool and saliva samples will be collected

Treatment with PD1/L1 + chemotherapy; Treatment with PD1/L1 monotherapy; Treatment with Tyrosine Kinase Inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with advanced/metastatic non-small cell lung cancer (NSCLC)

You may qualify if:

• \. Advanced/Metastatic non-small cell lung cancer NSCLC patients.
• \. The patient himself/herself must be 18 years of age on day of signing informed consent.
• \. The subject has signed the informed consent form.
• \. 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.
• \. 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Microbiota

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Misako Nagasaka, MD,PhD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

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

University of California Irvine Medical

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: January 31, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)