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

NCT ID: NCT06221800

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment with PD1/L1 monotherapy

Microbiome

Intervention Type DIAGNOSTIC_TEST

Stool and saliva samples will be collected

Treatment with PD1/L1 + chemotherapy

Microbiome

Intervention Type DIAGNOSTIC_TEST

Stool and saliva samples will be collected

Treatment with Tyrosine Kinase Inhibitor

Microbiome

Intervention Type DIAGNOSTIC_TEST

Stool and saliva samples will be collected

Interventions

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Microbiome

Stool and saliva samples will be collected

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Misako Nagasaka

Associate Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Misako Nagasaka, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Locations

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Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chao Family Comprehensive Cancer Center University of California, Irvine

Role: CONTACT

1-877-827-8839

University of California Irvine Medical

Role: CONTACT

Facility Contacts

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Misako Nagasaka, MD, PhD

Role: primary

877-827-8839

Other Identifiers

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UCI 22-86

Identifier Type: OTHER

Identifier Source: secondary_id

3887

Identifier Type: -

Identifier Source: org_study_id

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