This phase II trial studies if the radioactive compound called [18F]F-AraG is a helpful imaging agent during a PET/CT scan in detecting changes in anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen. A PET scan uses radioactive material injected into the blood to show the internal workings of the body. A CT scan uses x-rays and a computer to produce a 3-dimensional image of the body. Combining the two scans may help doctors better understand the extent and the exact location of disease. The purpose of this trial is to find out how the radiotracer called [18F]F-AraG can help investigate changes in cancer’s anti-tumor immune response (or activation of T-cell) levels during PET/CT.
Additional locations may be listed on ClinicalTrials.gov for NCT04524195.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate whether increased fluorine F 18 Ara-G ([18F]F-AraG) uptake in primary tumors following exposure to PD-1/PD-L1 immunotherapy correlates with percent pathologic response at time of surgical resection.
EXPLORATORY OBJECTIVES:
I. To descriptively report uptake of [18F]F-AraG in non-small cell lung cancer (NSCLC) primary tumors at baseline and after initiation of neoadjuvant PD-1/PD-L1 immunotherapy using radiomic analysis.
II. To descriptively report uptake of [18F]F-AraG in tracer-avid lymph nodes at baseline and after initiation of neoadjuvant PD-1/PD-L1 immunotherapy using radiomic analysis.
III. To correlate change in primary tumor uptake of [18F]F-AraG on positron emission tomography (PET)/computed tomography (CT) before and after immunotherapy with recurrence-free survival in patients treated with neoadjuvant immunotherapy.
IV. To correlate uptake of [18F]F-AraG and [18F]-fluorodeoxyglucose ([18F]-FDG) on PET/CT in primary NSCLC tumors at baseline.
OUTLINE:
Patients receive fluorine F 18 Ara-G intravenously (IV) and undergo PET/CT at baseline (within 7 days before starting immunotherapy) and 10-14 days after first dose of immunotherapy.
After completion of study, patients are followed up within 7 days.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorMartin Pomper
