Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

Description

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.

Conditions

Lung Cancer, NSCLC, NSCLC Stage IV

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Study Overview

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Study Details

Study overview

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.

Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC (TUMORIN)

Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

Condition
Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Fairway

The University of Kansas Cancer Center (KUCC), Fairway, Kansas, United States, 66205

Kansas City

The University of Kansas Cancer Center, Westwood Campus, Kansas City, Kansas, United States, 66205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Incarcerated
  • * Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.

Ages Eligible for Study

18 Years to 110 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jun Zhang, MD, PhD,

Jun Zhang, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

2027-02