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UnknownNot applicableNCT04636775
Official study title

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

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedMicrobiome

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 11, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Jun Zhang, MD, PhD

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Jun Zhang, MD, PhD
Interventions being studied
Diagnostic Test: Microbiome
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→Recurrent or relapsed→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • The University of Kansas Cancer Center (KUCC)Fairway, Kansas
  • The University of Kansas Medical CenterKansas City, Kansas
  • The University of Kansas Cancer Center, Westwood CampusKansas City, Kansas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 11, 2023. Always confirm current availability with the study team.

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