Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG

• Status: Not yet recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This pilot study uses [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in [18F]F AraG PET signal before and while on CkIT therapy and to correlate this change in [18F]F AraG PET signal with radiographic response.

To explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment [18F]F AraG PET/CT scans, and will be followed up for 12 months for assessment of radiographic and clinical outcomes. This study is a single-site, open label, non randomized, single arm pilot trial. Patients and care providers will not be blinded to any part of the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CellSight Technologies, Inc.

Criteria

Inclusion Criteria:

1. Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease.

2. Measurable disease.

3. ECOG performance status of 0, 1 or 2.

4. Subjects are willing to be followed at the University of Iowa.

Exclusion Criteria:

1. Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.

2. Pregnant women or nursing mothers.

3. Patients with severe claustrophobia.