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

Non Small Cell Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221800
• Other study ID #: 3887
• Secondary ID: UCI 22-86
• Status: Recruiting
• Start date: January 31, 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: Chao Family Comprehensive Cancer Center University of California
• Phone: 1-877-827-8839
• Email: ucstudy[@]uci.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Diagnostic Test:
• Microbiome
Stool and saliva samples will be collected

Locations

Country	Name	City	State
United States	Chao Family Comprehensive Cancer Center University of California, Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

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