Clinical Trial 18611

Cancer Type: Thoracic
Interventions:

Study Type: Other
Phase of Study: NA
Investigators:

  • Christine Pierce

Overview

Study Title

The Gut Microbiome and Immunotherapy in Non-small Cell Lung Cancer

Summary

The purpose of this study is to obtain information on the microbiome ¿ bacteria and other microbes living all over the outside and inside the human body. Specifically, we would like to know more about the gut microbiome of patients with advanced lung cancer who plan to receive checkpoint inhibitor immunotherapy treatment at Moffitt Cancer Center. We want to understand how the gut microbiome changes within an individual patient undergoing immunotherapy, assess how the gut microbiome differs among patients undergoing immunotherapy, and examine whether the gut microbiome is associated with the way patients respond to cancer immunotherapy.

Objective

We propose to recruit 30 lung cancer patients who are about to begin treatment with immunotherapy at Moffitt Cancer Center, enroll them into a prospective study of the gut microbiome, and build a microbiome biospecimen repository for subsequent grant proposals. Patients will provide fecal and blood specimens at two time points: before the start of immunotherapy (baseline) and eight weeks after the start of immunotherapy (follow-up). The short-term goals of this study are to obtain preliminary data on the gut bacterial microbiome of patients with advanced lung cancer. The long-term goals of this study, and focus of future grant proposals, are to understand how the gut microbiome changes within an individual patient undergoing immunotherapy, to assess how the gut microbiome differs among patients undergoing immunotherapy, and to examine whether the gut microbiome is associated with the response to cancer immunotherapy. To date, no studies have been conducted in humans to examine whether the microbiome may affect the response to cancer immunotherapy. The specific aims of this study are: Aim 1: To enroll 30 patients with stage IV lung adenocarcinoma who are about to begin treatment with immune checkpoint inhibitors into a prospective gut microbiome study. Aim 2: To characterize the gut microbiome of patients with stage IV lung adenocarcinoma, prior to receiving immune checkpoint inhibitors (preliminary data for future grant applications).

Inclusion Criteria

  • Men and women ≥18 years of age
  • Diagnosed with stage IV non-small cell lung adenocarcinoma
  • Plan to be treated at Moffitt Cancer Center with a checkpoint inhibitor as a single agent or in combination with another checkpoint inhibitor (e.g., nivolumab, ipilimumab, etc.)
  • History of ≤2 failed chemotherapy treatment regimens
  • Able to provide informed consent

  • Exclusion Criteria

  • Mental incompetence or chronic psychiatric disease
  • Incarcerated individuals