This pilot study uses \[18F\]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in \[18F\]F AraG PET signal before and while on CkIT therapy and to correlate this change in \[18F\]F AraG PET signal with radiographic response.
To explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment \[18F\]F AraG PET/CT scans, and will be followed up for 12 months for assessment of radiographic and clinical outcomes. This study is a single-site, open label, non randomized, single arm pilot trial. Patients and care providers will not be blinded to any part of the study.
Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease.
Measurable disease.
ECOG performance status of 0, 1 or 2.
Subjects are willing to be followed at the University of Iowa.
Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
Pregnant women or nursing mothers.
Patients with severe claustrophobia.
Single group
[18F]F-AraG
DrugTwo PET scans
[18F]F-AraG Quantification
Quantitative assessment of tracer uptake by Standardized Uptake Value (SUV) based measurements within volumes of interest on pre- and on-treatment \[18F\]F AraG PET scans compared.
[18F]F AraG Correlation
Comparison of quantitative change in tracer uptake between pre- and on-treatment with radiographic outcomes as defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) \> 4 months.
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