Actively Recruiting

Age: 18Years - 110Years
All Genders
NCT05332925

Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

Led by Jun Zhang, MD, PhD · Updated on 2024-02-23

25

Participants Needed

2

Research Sites

236 weeks

Total Duration

On this page

Sponsors

J

Jun Zhang, MD, PhD

Lead Sponsor

N

Nilogen Oncosystems

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

Who Can Participate

Age: 18Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand the study and provide written informed consent
  • Diagnosis of advanced or metastatic NSCLC
  • No prior immunotherapy treatment
  • Male or female age 18 years or older
  • ECOG performance status between 0 and 2
  • Measurable disease according to RECIST 1.1
  • Presence of a lesion suitable for safe biopsy with sufficient tissue (at least 3-4 cores with 20g or larger biopsy needle) to create tumoroids
  • At least one target lesion available to evaluate treatment response
  • Planned treatment with anti-PD-1/L1 with or without anti-CTLA-4 as standard care
  • Adequate organ function as defined by standard of care
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to use contraception or abstain as recommended for immune checkpoint inhibitor treatment
Not Eligible

You will not qualify if you...

  • Incarcerated individuals
  • Not competent to make medical decisions, noncommunicative, or noncompliant as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 2 locations

1

The University of Kansas Cancer Center (KUCC)

Fairway, Kansas, United States, 66205

Actively Recruiting

2

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, United States, 66205

Actively Recruiting

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Research Team

D

Darlene Kocher

CONTACT

J

Jonathon Barnette

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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