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

Recruiting

• Conditions: NSCLC, Recurrent; NSCLC Stage IV
• Interventions: Diagnostic Test: Microbiome

• Registration Number: NCT04636775
• Lead Sponsor: Jun Zhang, MD, PhD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-29
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11
• Primary Completion: 2024-08-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immunotherapy naïve NSCLC patients	Microbiome	Microbiome in immunotherapy naïve NSCLC patients receiving PD-1/L1 blockade

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, 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