Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

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 standard of care clinical setting.

Eligibility

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.

Conditions4

Locations2 sites

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