RECRUITING

Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

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Conditions

Lung CancerNSCLCNSCLC Stage IVTumoroidsOrganoidsImmunotherapyImmune check point inhibitorAnti-PD-1Anti-CTLA-4Ex vivo model3D culture

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-07-21
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05332925

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.

Ages Eligible for Study:18 Years to 110 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  2. * Patients with advanced/metastatic NSCLC
  3. * Must be immunotherapy naive
  4. * Males and females age ≥ 18 years
  5. * ECOG Performance Status 0 - 2
  6. * Measurable disease by RECIST 1.1
  7. * 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
  8. * Must have at least one target lesion to evaluate treatment response
  9. * 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.
  10. * 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.
  1. * Incarcerated
  2. * Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.

Contacts and Locations

Study Contact

Darlene Kocher
CONTACT
9135887132
dkocher@kumc.edu
Jonathon Barnette
CONTACT
9135887132
jbarnette@kumc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Jun Zhang, MD, PhD

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-21
Study Completion Date2027-02

Study Record Updates

Study Start Date2022-07-21
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • Tumoroids
  • Organoids
  • Immunotherapy
  • Immune check point inhibitor
  • Anti-PD-1
  • Anti-CTLA-4
  • Ex vivo model
  • 3D culture

Additional Relevant MeSH Terms

  • Lung Cancer
  • NSCLC
  • NSCLC Stage IV