NCT05332925 Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
| NCT ID | NCT05332925 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jun Zhang, MD, PhD |
| Condition | Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-07-21 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2022-07-21 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Jun Zhang, MD, PhD
PRINCIPAL INVESTIGATOR
University of Kansas Medical Center
Frequently Asked Questions
Who can join the NCT05332925 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05332925 currently recruiting?
Yes, NCT05332925 is actively recruiting participants. Contact the research team at dkocher@kumc.edu for enrollment information.
Where is the NCT05332925 trial being conducted?
This trial is being conducted at Fairway, United States, Kansas City, United States.
Who is sponsoring the NCT05332925 clinical trial?
NCT05332925 is sponsored by Jun Zhang, MD, PhD. The principal investigator is Jun Zhang, MD, PhD at University of Kansas Medical Center. The trial plans to enroll 25 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.