Search / Trial NCT06221800

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

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

Trial Information

Current as of December 30, 2024

Recruiting

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.

Trial Officials

Misako Nagasaka, MD,PhD

Principal Investigator

Chao Family Comprehensive Cancer Center

About University Of California, Irvine

The University of California, Irvine (UCI) is a leading research institution renowned for its commitment to advancing health and medical knowledge through innovative clinical trials. With a robust infrastructure for clinical research, UCI fosters interdisciplinary collaboration among its esteemed faculty and researchers, aiming to translate scientific discoveries into effective therapeutic solutions. The university prioritizes ethical standards and participant safety while addressing critical healthcare challenges across various fields, including cancer, neurology, and public health. UCI's dedication to excellence in research and education positions it as a pivotal contributor to the advancement of clinical science and patient care.

Locations

Orange, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0