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

NCT04636775 | Unknown DMC

• 1 other identifier: IIT-2020-MIP-NSCLC
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

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

Keywords

Advanced NSCLC; Metastatic NSCLC; Recurrent NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Microbiome difference between responders vs. nonresponders

  Through study completion, an average of 1 year

• Correlation of microbiome to tumor tissue PD-L1 expression

  Through study completion, an average of 1 year

• Correlation of microbiome to diet

  Through study completion, an average of 1 year

Study Arms (1)

Immunotherapy naïve NSCLC patients

Microbiome in immunotherapy naïve NSCLC patients receiving PD-1/L1 blockade

Diagnostic Test: Microbiome

Interventions

Microbiome DIAGNOSTIC_TEST

Nasal and buccal swabs, and stool sample, as well as the extracted DNAs

Immunotherapy naïve NSCLC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jun Zhang, MD, PhD: lead

Study Sites (3)

The University of Kansas Cancer Center (KUCC)

Fairway, Kansas, 66205, United States

RECRUITING

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 29781826 BACKGROUND

• 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.

  PMID: 30183502 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Nasal and buccal swabs, and stool sample, as well as the extracted DNAs for current and future, study-related research

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Recurrence

Interventions

Microbiota

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Jun Zhang, MD, PhD

  The University of Kansas Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KUCC Navigation

CONTACT

9135883671; kucc_Navigation@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor; Principal Investigator

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: July 29, 2020
• Primary Completion: August 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)