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

University of California Irvine (UCI)

Status: Enrolling

Conditions: Non Small Cell Lung Cancer

Treatments: Diagnostic Test: Microbiome

Study type: Observational

Funder types: Other

Identifiers

NCT06221800

3887

UCI 22-86 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

82 participants in 3 patient groups

Treatment with PD1/L1 monotherapy

Treatment:

Diagnostic Test: Microbiome

Treatment with PD1/L1 + chemotherapy

Treatment:

Diagnostic Test: Microbiome

Treatment with Tyrosine Kinase Inhibitor

Treatment:

Diagnostic Test: Microbiome