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Observational Study: Predicting Immunotherapy Response in NSCLC

This study is looking at how well a new laboratory test, called a 3D ex-vivo tumoroid model, can predict if immunotherapy will work for people with advanced non-small cell lung cancer (NSCLC). Researchers will use tissue samples from patients who are starting standard-of-care immune checkpoint inhibitors (like anti-PD-1/L1, with or without anti-CTLA-4). The goal is to see if this lab model can help doctors understand who will benefit most from these treatments. You may be able to join if you have advanced NSCLC, are at least 18 years old, and have not received immunotherapy before. The study aims to enroll 25 participants and will measure the success of creating these tumoroid models over two years.

Study design
This is an observational study, meaning researchers will watch what happens without giving new treatments. It plans to include 25 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of establishing the tumoroid model will be measured at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05332925

Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

Recruiting
Not specifiedAges 18+Observational
Jun Zhang, MD, PhD
~25 participants
Updated 2024-02-23 on ClinicalTrials.gov
What's tested:Standard of care immune checkpoint inhbitors

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of establishing 3D ex-vivo tumoroid model
Measured over 2 years

Conditions

Lung Cancer
NSCLC
NSCLC Stage IV

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

2 sites across 1 states
Kansas2

Study leadership

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

Who to contact

Darlene Kocher
[email protected]
9135887132
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Feasibility of establishing 3D ex-vivo tumoroid model2 years

    Twenty-five patients will be enrolled. The bioassay will be considered to be feasible if the 3D Ex-Vivo assay results are obtained on at least 20 patients.