Status:

RECRUITING

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

Lead Sponsor:

University of California, Irvine

Conditions:

Non Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

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.

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.

Key Trial Info

Start Date :

January 31 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

82 Patients enrolled

Trial Details

Trial ID

NCT06221800

Start Date

January 31 2024

End Date

December 1 2025

Last Update

February 10 2025

Active Locations (1)

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Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, United States, 92868