RecruitingNCT05332925

Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

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


Sponsor

Jun Zhang, MD, PhD

Enrollment

25 participants

Start Date

Jul 21, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 110 Years

Inclusion Criteria10

  • 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.

Exclusion Criteria2

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

Interventions

DRUGStandard of care immune checkpoint inhbitors

This is NOT an interventional study.


Locations(2)

The University of Kansas Cancer Center (KUCC)

Fairway, Kansas, United States

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, United States

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NCT05332925


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