Using patient-derived tumoroids to predict response to immunotherapy in lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the feasibility of using 3D ex-vivo tumoroids derived from fresh biopsies of patients with advanced non-small cell lung cancer (NSCLC) to predict their response to immune checkpoint inhibitors. By analyzing these tumoroids, the researchers hope to identify which patients are likely to benefit from immunotherapy and understand the mechanisms of resistance. The study will focus on immunotherapy-naive patients who are set to receive standard-of-care anti-PD-1/L1 treatments. The goal is to enhance treatment personalization and improve outcomes for NSCLC patients.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

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

Where it's running

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

Study contacts

• Principal investigator: Jun Zhang, MD, PhD — University of Kansas Medical Center
• Study coordinator: Darlene Kocher
• Email: dkocher@kumc.edu
• Phone: 9135887132

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.