This trial studies how well [18F]-AraG works in detecting T-cell activation in patients with non-small cell lung cancer that has spread to other places in the body (advanced), who are undergoing PD-1/PD-L1-directed therapy. [18F]-AraG is a “radiotracer” which attaches to immune cells directed at the cancer and shines a light that can be seen using a special camera, called a “positron emission tomography” or “PET” scanner. [18F]-AraG may improve the ability to detect a response of the cancer in the body to immunotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04186988.
PRIMARY OBJECTIVES:
I. To quantify fluorine F 18 Ara-G ([18F]-AraG) uptake (standardized uptake value [SUV]) in advanced non-small cell lung cancer (NSCLC) tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in both patients treated with PD-1/PD-L1 monotherapy and in patients treated with immunotherapy/chemotherapy combination therapy.
II. To correlate change in [18F]-AraG uptake before and after the start of therapy with radiographic response in patients treated with immunotherapy.
OUTLINE:
Patients receive [18F]-AraG intravenously (IV) and then undergo PET/CT over 2 hours at baseline and within 2 weeks after starting immunotherapy. Patients may also undergo blood sample collection.
After completion of study treatment, patients are followed for up to 12 months.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUniversity of California Davis Comprehensive Cancer Center
Principal InvestigatorJulie Sutcliffe
