Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorJun Zhang, MD, PhD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Incarcerated
Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.
Trial population
Advanced/metastatic NSCLC patients who are immunotherapy naïve and ready to receive immune checkpoint inhibitors as standard--of-care treatment.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Standard of care immune checkpoint inhbitors
DrugThis is NOT an interventional study.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Feasibility of establishing 3D ex-vivo tumoroid model
Twenty-five patients will be enrolled. The bioassay will be considered to be feasible if the 3D Ex-Vivo assay results are obtained on at least 20 patients.
Time frame
2 yearsSecondary outcomes
1
Correlation of response in ex vivo tumoroids with clinical objective response
To test whether the 3D-EX functional response bioassay can predict tumor response (using RECIST v1.1) in patients with advanced/metastatic NSCLC, receiving treatment with immune checkpoint inhibitors, in a standard clinical setting.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jun Zhang, MD, PhD
Lead sponsor
University of Kansas Medical Center
Sponsor institution
Nilogen Oncosystems
Collaborator
Source ClinicalTrials.gov