RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-07-29
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04636775

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must have tumor tissue biopsy-proven to be NSCLC
  2. * Must have a target lesion to evaluate treatment response
  3. * Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients
  4. * 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
  1. * Prior treatment with any forms of cancer immunotherapy
  2. * Not competent to make medical decision, noncommunicative or noncompliant per treating physician's judgement
  3. * Not English-speaking
  4. * Patients that are pregnant
  5. * Prisoners
  6. * Students and employees
  7. * Psychiatric illness/social situations that would limit compliance with study requirements

Contacts and Locations

Study Contact

KUCC Navigation
CONTACT
9135883671
kucc_Navigation@kumc.edu

Principal Investigator

Jun Zhang, MD, PhD
PRINCIPAL_INVESTIGATOR
The University of Kansas Cancer Center

Study Locations (Sites)

The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, 66205
United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
United States

Collaborators and Investigators

Sponsor: Jun Zhang, MD, PhD

  • Jun Zhang, MD, PhD, PRINCIPAL_INVESTIGATOR, The University of Kansas Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-29
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2020-07-29
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Advanced NSCLC
  • Metastatic NSCLC
  • Recurrent NSCLC

Additional Relevant MeSH Terms

  • NSCLC Stage IV
  • NSCLC, Recurrent