Status:
RECRUITING
Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
Lead Sponsor:
Jun Zhang, MD, PhD
Collaborating Sponsors:
Nilogen Oncosystems
Conditions:
Lung Cancer
NSCLC
Eligibility:
All Genders
18-110 years
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 stan...
Detailed Description
Non-small cell lung cancer (NSCLC), which accounts for approximately 85% of all lung cancer cases, remains the leading cause of cancer death worldwide. Immunotherapy such as using immune checkpoint in...
Eligibility Criteria
Inclusion
- 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
- Incarcerated
- Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.
Key Trial Info
Start Date :
July 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05332925
Start Date
July 21 2022
End Date
February 1 2027
Last Update
February 23 2024
Active Locations (2)
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1
The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, United States, 66205
2
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States, 66205