Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
Recruiting now
Conditions studied: Lung Cancer, NSCLC, NSCLC Stage IV
In brief
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.
Key facts
- Study ID
- NCT05332925
- Run by
- Jun Zhang, MD, PhD
- People needed
- 25
- Starts
- 2022-07-21
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2024-02-23
Who can join
Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Incarcerated
- Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.
Where it is running
- The University of Kansas Cancer Center (KUCC) — Fairway, Kansas, United States (enrolling)
- The University of Kansas Cancer Center, Westwood Campus — Kansas City, Kansas, United States (enrolling)
Full record on ClinicalTrials.gov
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