Overview

[18F]-AraG for the Detection of T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing PD-1/PD-L1-Directed Therapy

Status:
Recruiting
Trial end date:
2021-12-13
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, Davis
Collaborators:
CellSight Technologies, Inc.
National Cancer Institute (NCI)
Treatments:
9-arabinofuranosylguanine
Criteria
Inclusion Criteria:

- This study is open to all adult subjects with histological confirmation of NSCLC
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

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3 at the
time of enrollment

- Patient with life expectancy >= 24 weeks from the time of screening to the study

- Ability to sign and understand the Institutional Review Board (IRB)-approved consent
form in English

- Ability to remain motionless for up to 30 minutes per scan

Exclusion Criteria:

- Patients with severe claustrophobia (patients with milder forms of claustrophobia that
can be successfully allayed with oral anxiolytic therapy are allowed)

- Severe impaired renal function with estimated glomerular filtration rate < 30
mL/min/1.73 m^2 and/or on dialysis

- Pregnancy

- Breast feeding an infant

- Prior treatment with anti-PD-1/PD-L1 inhibitor

- Localized/locally advanced disease with anti PD-1/PD-L1 given as consolidation