Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
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.
Checked against the public recordLast updated Feb 23, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Jun Zhang, MD, PhD
- Interventions being studied
- Drug: Standard of care immune checkpoint inhbitors
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- The University of Kansas Cancer Center (KUCC)Fairway, Kansas
- The University of Kansas Cancer Center, Westwood CampusKansas City, Kansas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 23, 2024. Always confirm current availability with the study team.