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RecruitingNot applicableNCT05332925
Official study title

Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

Study summary

To test whether it is feasible to perform the 3D-EX functional predictive response bioassay in the context of patients with advanced/metastatic NSCLC receiving immune checkpoint inhibitors in the standard of care clinical setting.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedStandard of care immune checkpoint inhbitors

The study team can explain what participation involves.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 23, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Observational

Where is it offered?2 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
Drug: Standard of care immune checkpoint inhbitors
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→
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
  • Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  • Patients with advanced/metastatic NSCLC
  • Must be immunotherapy naive
  • Males and females age ≥ 18 years
  • ECOG Performance Status 0 - 2
  • Measurable disease by RECIST 1.1
  • Must have a lesion (either primary or metastatic lesion) that can be safely biopsied to have sufficient tissue (at minimum, 3-4 cores using 20g or larger core biopsy) to generate tumoroids
  • Must have at least one target lesion to evaluate treatment response
  • Will be receiving anti-PD-1/L1 with or without anti-CTLA-4 per standard of care Adequate organ function defined per standard of care in this setting.
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception as required/recommended by each immune checkpoint inhibitor used in the setting of standard of care.
Reasons someone may not be able to joinExclusion criteria
  • Incarcerated
  • Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.

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 Cancer Center, Westwood CampusKansas City, Kansas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 23, 2024. Always confirm current availability with the study team.

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