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

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

This study is testing if lab-grown mini tumors from lung cancer patients can help doctors figure out who will benefit from a new type of immune therapy.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years to 110 Years
• Sex: All
• Sponsor: University of Kansas Medical Center (other)
• Drugs / interventions: immunotherapy
• Locations: 2 sites (Fairway, Kansas and 1 other locations)
• Trial ID: NCT05332925 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with advanced or metastatic NSCLC who have not previously received immunotherapy.

Not a fit: Patients who have already undergone immunotherapy or those with ECOG performance status greater than 2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatment strategies for patients with NSCLC by identifying those who are most likely to respond to immunotherapy.

How similar studies have performed: While the use of tumoroids in predicting treatment response is a novel approach, similar studies have shown promise in other cancer types, indicating potential for success in this context.

Eligibility criteria

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 this trial is running

Fairway, Kansas and 1 other locations

• 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

Conditions: Lung Cancer, NSCLC, NSCLC Stage IV, Tumoroids, Organoids, Immunotherapy, Immune check point inhibitor, Anti-PD-1