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

Recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: Diagnostic Test: Microbiome

• Registration Number: NCT06221800
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-24
• Study Start: 2024-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment with PD1/L1 monotherapy	Microbiome	-
Treatment with PD1/L1 + chemotherapy	Microbiome	-
Treatment with Tyrosine Kinase Inhibitor	Microbiome	-

Primary Outcome Measures

Name	Time	Method
Gut microbiomes in advanced/metastatic NSCLC patients	Up to 2 years	To summarize the diversity and composition of gut microbiomes at baseline or prior to initiation of therapy

Secondary Outcome Measures

Name	Time	Method
Change in microbiome diversity and composition from baseline (prior to start of therapy) to first post-treatment evaluation scan.	Up to 2 years	Relative difference (and if necessary, relative ratio) between baseline and the first post-evaluation scan
Progression-Free Survival (PFS)	Up to 2 years	Duration from the start date of treatment to the date of progression or death from any cause, whichever occurs first.
Overall survival (OS)	Up to 2 years	Duration from the start date of treatment to the date of death from any cause.
Clinical Response Rate (RR)	Up to 2 years	Defined according to RECIST v1.1 criteria

Trial Locations

Locations (1)

Chao Family Comprehensive Cancer Center University of California, Irvine; 🇺🇸 Orange, California, United States