[18F]F-ARAG Uptake in Tumors and Non-Cancer Tissue using PET Imaging in Healthy Subjects and Patients with Non-small Cell Lung Cancer

Inclusion Criteria

• FOR ALL SUBJECTS: Age >= 18 years
• FOR ALL SUBJECTS: Ability to understand the purposes and risks of the trial and has signed an Institutional Review Board (IRB)-approved informed consent form
• FOR ALL SUBJECTS: Willingness and ability to comply with all protocol required procedures
• FOR ALL SUBJECTS: For men and women of child-producing potential, willingness to use of effective double barrier contraceptive methods during the study, up to 1 day after the last administration of the investigational product
• FOR NSCLC SUBJECTS ONLY: Patients with histologically confirmed advanced, locally advanced, or localized NSCLC
• FOR NSCLC SUBJECTS ONLY: Planned to undergo treatment with a PD-1 or PD-L1 inhibitor either as * Monotherapy or as combination therapy with concurrent chemotherapy as treatment for advanced/metastatic disease * As consolidation therapy following chemoradiation for locally advanced disease or * As induction therapy either as monotherapy or combination therapy with chemotherapy prior to planned surgical resection
• FOR NSCLC SUBJECTS ONLY: At least 1 tumor lesion > 1 cm (cannot be only in liver) documented on CT or magnetic resonance imaging (MRI) or fludeoxyglucose F-18 (FDG)-PET/CT (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1; > 1.5 cm for nodal lesions) within 45 days prior to scan date
• FOR NSCLC SUBJECTS ONLY: Per investigator’s assessment and in consultation with oncologists, at least one eligible lesion must be sufficiently separated from tissues with known high [18F]F-AraG uptake, such as salivary glands, bladder, liver and kidneys so that quantification will be feasible
• FOR NSCLC SUBJECTS ONLY: Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• FOR NSCLC SUBJECTS ONLY: Meeting all clinical safety lab values per institution’s standard of care, or investigator’s discretion, for patients receiving cancer treatment

Exclusion Criteria

• Serious comorbidities (nonmalignant disease or other conditions) that in the opinion of the investigator could compromise protocol objectives
• History of COVID-19 infection within the last 2 months OR history of COVID requiring hospitalization with lung injury at investigator’s discretion
• Subjects with a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the scan
• Subjects receiving therapy with nucleoside analogs including but not limited to: acyclovir, valaclovir, penciclovir, famciclovir, ganciclovir, ribavirin, valganciclovir, glanciclovir
• Pregnant women or nursing mothers
• Body weight more than 240 kg (529 pounds)
• FOR NSCLC SUBJECTS ONLY: Prior treatment with anti-PD-1/PD-L1 immunotherapy
• FOR HEALTHY SUBJECTS: No primary care physician