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

NSCLC Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636775
• Other study ID #: IIT-2020-MIP-NSCLC
• Status: Recruiting
• Start date: July 29, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University of Kansas Medical Center
• Contact: KUCC Navigation
• Phone: 9135883671
• Email: kucc_Navigation[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC Stage IV
• NSCLC, Recurrent

Intervention

Diagnostic Test:
• Microbiome
Nasal and buccal swabs, and stool sample, as well as the extracted DNAs

Locations

Country	Name	City	State
United States	The University of Kansas Cancer Center (KUCC)	Fairway	Kansas
United States	The University of Kansas Cancer Center, Westwood Campus	Kansas City	Kansas
United States	The University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Jun Zhang, MD, PhD

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Correlation of microbiome to diet	Customized Diet Survey	Through study completion, an average of 1 year