drugset / Trial / NCT06107374

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

NCT06107374 ↗

Phase 2 Recruiting 20 enrolled CellSight Technologies, Inc.
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2023-11-01
Primary completion
2025-12-31
Completion
2026-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject F-ARAG Diagnostic / imaging agent — —