[18F]F-AraG/Total Body PET Imaging and Healthy Subjects and Lung Cancer Patients

Inclusion Criteria

• Age ≥ 18 years.
• Ability to understand the purposes and risks of the trial and has signed an IRB-approved informed consent form.
• Willingness and ability to comply with all protocol required procedures.
• 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.
• Planned to undergo treatment with a PD-1 or PD-L1 inhibitor either as 1) monotherapy or as combination therapy with concurrent chemotherapy as treatment for advanced/metastatic disease; 2) As consolidation therapy following chemoradiation for locally advanced disease or 3) As induction therapy either as monotherapy or combination therapy with chemotherapy prior to planned surgical resection
• At least 1 tumor lesion > 1 cm (cannot be only in liver) documented on CT or MRI or FDG-PET/CT (RECIST criteria 1.1; >1.5 cm for nodal lesions) within 45 days prior to scan date.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Meeting all clinical safety lab values per institution's standard of care, or Investigator's discretion, for patients receiving cancer treatment.

Exclusion Criteria

Subjects are not eligible if they meet ANY of the following criteria:

• Serious comorbidities (nonmalignant disease or other conditions) that in the opinion of the investigator could compromise protocol objectives.
• History of recent 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