Clinical Trials Search
Clinical Trial 18611
Study Type: Other
Phase of Study: NA
- Christine Pierce
The Gut Microbiome and Immunotherapy in Non-small Cell Lung Cancer
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.
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).