PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)

• Status: Recruiting
• Trial end date: 2027-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called [18F]F-AraG is a helpful imaging agent for detecting changes in cancer's 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 (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: CellSight Technologies, Inc.; Stand Up To Cancer

Criteria

Inclusion Criteria:

• Age 18 years or older and willing and able to provide informed consent.

• Subjects with stage I, II, or III A NSCLC and plan to receive neoadjuvant PD-1/PD-L1 immunotherapy with an intention for curative surgery. Subjects will be receiving neoadjuvant immunotherapy through enrollment in therapeutic clinical trials

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at the time of enrollment.

• For females of childbearing potential, negative serum pregnancy test within a 10 day period will be obtained prior to PET study.

Exclusion Criteria:

• Severe impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73 m2 and/or on dialysis.

• Pregnant female patients; breastfeeding female patients.

• Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.

• Any investigational radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem.

• Administered a radioisotope ≤5 physical half-lives prior to the day of PET/CT.