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

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Jan 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the gut microbiome, which is the community of bacteria and other microorganisms living in our intestines, in patients with advanced non-small cell lung cancer (NSCLC). The goal is to understand how the diversity and makeup of these gut bacteria change while patients are receiving treatment. By studying this, researchers hope to find out if there is a connection between gut health and the effectiveness of cancer treatments, as well as any side effects that may occur.

To participate, patients need to be at least 18 years old and have advanced or metastatic NSCLC. They should be eligible for certain cancer therapies, including specific types of immunotherapy or targeted therapy. Participants will be asked to provide samples for analysis, which will help researchers gather important data. It's important to note that patients who are not stable enough to join the study, as determined by their doctor, will not be eligible. This study is currently recruiting participants, and it offers a chance to contribute to understanding how gut health may impact cancer treatment outcomes.

Gender

ALL

Eligibility criteria

• 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.