Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
Recruiting · NCT05332925 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Standard of care immune checkpoint inhbitors
What this trial is about
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.
Who can take part
Age range
18 Years to 110 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
2 locations listed across 1 US state.
- The University of Kansas Cancer Center (KUCC) - Fairway, Kansas, United States
- The University of Kansas Cancer Center, Westwood Campus - Kansas City, Kansas, United States