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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC Stage IV; NSCLC, Recurrent
• Intervention / Treatment: Diagnostic test: Microbiome

• Study Type: Observational
• Enrollment (Estimated): 46

Contacts and Locations

• Study Contact: Name: KUCC Navigation; Phone Number: 9135883671; Email: kucc_navigation@kumc.edu

Study Locations

• United States
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Recruiting
      • The University of Kansas Cancer Center (KUCC)
      • Contact: KUCC Navigator; Phone Number: 913-588-3671; Email: kucc_navigation@kumc.edu
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • The University of Kansas Medical Center
    • Kansas City, Kansas, United States, 66205
      • Recruiting
      • The University of Kansas Cancer Center, Westwood Campus
      • Contact: KUCC Navigation; Phone Number: 913-588-3671; Email: kucc_navigation@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome difference between patients with and without AEs>=grade 3	Adverse events (AEs) will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome difference between responders vs. nonresponders	Treatment response will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1	Through study completion, an average of 1 year
Correlation of microbiome to tumor tissue PD-L1 expression	PD-L1 expression is per standard of care using IHC	Through study completion, an average of 1 year
Correlation of microbiome to diet	Customized Diet Survey	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Jun Zhang, MD, PhD
• Investigators: Principal Investigator: Jun Zhang, MD, PhD, The University of Kansas Cancer Center

Publications and helpful links

General Publications

• Swami U, Zakharia Y, Zhang J. Understanding Microbiome Effect on Immune Checkpoint Inhibition in Lung Cancer: Placing the Puzzle Pieces Together. J Immunother. 2018 Oct;41(8):359-360. doi: 10.1097/CJI.0000000000000232.
• Strouse C, Mangalam A, Zhang J. Bugs in the system: bringing the human microbiome to bear in cancer immunotherapy. Gut Microbes. 2019;10(2):109-112. doi: 10.1080/19490976.2018.1511665. Epub 2018 Sep 5.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Metastatic NSCLC; Recurrent NSCLC; Advanced NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: IIT-2020-MIP-NSCLC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No