Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)

Purpose

This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. In addition, the investigator will look into microbiome changing modifiers.

Conditions

  • NSCLC Stage IV
  • NSCLC, Recurrent

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Must have tumor tissue biopsy-proven to be NSCLC - Must have a target lesion to evaluate treatment response - Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients - Will receive single agent anti-PD-1/PD-L1 therapy (e.g. pembrolizumab, nivolumab, atezolizumab, avelumab or durvalumab, etc.). Patients can be on other interventional trial if they will be receiving single agent anti-PD-1/PD-L1

Exclusion Criteria

  • Prior treatment with any forms of cancer immunotherapy - Not competent to make medical decision, noncommunicative or noncompliant per treating physician's judgement - Not English-speaking - Patients that are pregnant - Prisoners - Students and employees - Psychiatric illness/social situations that would limit compliance with study requirements

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Immunotherapy naïve NSCLC patients Microbiome in immunotherapy naïve NSCLC patients receiving PD-1/L1 blockade
  • Diagnostic Test: Microbiome
    Nasal and buccal swabs, and stool sample, as well as the extracted DNAs

Recruiting Locations

The University of Kansas Cancer Center (KUCC)
Fairway, Kansas 66205
Contact:
KUCC Navigator
913-588-3671
kucc_navigation@kumc.edu

The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas 66205
Contact:
KUCC Navigation
913-588-3671
kucc_navigation@kumc.edu

The University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
Jun Zhang, MD, PhD

Study Contact

KUCC Navigation
9135883671
kucc_Navigation@kumc.edu