NCT05332925Recruiting
Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC (TUMORIN)
Source: ClinicalTrials.gov · Last updated 23 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 10 Apr 2022
- Start date
- 21 Jul 2022
- Primary completion date
- Jan 2026
- Lead sponsor
- Jun Zhang, MD, PhD
- Diseases
- Lung cancer
- NCT number
- NCT05332925
What you commit to
- Study type: Observational
- Planned participants: 25
- From 21 Jul 2022 to the primary completion date, Jan 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Incarcerated
- Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.
Who the study is looking for
- 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.
Age in the registry: 18 years to 110 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Kansas Cancer Center (KUCC) Coordinator of this site? Confirm its status | Fairway | United States | Recruiting |
| The University of Kansas Cancer Center, Westwood Campus Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.