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NCT Number: NCT06221800

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868, United States

Location status: Recruiting

Location contact

Misako Nagasaka, MD, PhD

CONTACT

[email protected]

877-827-8839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Microbiome

Diagnostic Test

Stool and saliva samples will be collected

Primary outcomes

  1. Gut microbiomes in advanced/metastatic NSCLC patients

    Time frame: Up to 2 years

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

Secondary outcomes

  1. 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

    Relative difference (and if necessary, relative ratio) between baseline and the first post-evaluation scan

  2. Clinical Response Rate (RR)

    Time frame: Up to 2 years

    Defined according to RECIST v1.1 criteria

  3. Progression-Free Survival (PFS)

    Time frame: Up to 2 years

    Duration from the start date of treatment to the date of progression or death from any cause, whichever occurs first.

  4. Overall survival (OS)

    Time frame: Up to 2 years

    Duration from the start date of treatment to the date of death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

1-877-827-8839

University of California Irvine Medical

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2024
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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