NCT04726215

Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer

Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1 Directed Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: CellSight Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study using \[18F\]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors at multiple study sites. The main objectives of the study are to quantify the change in \[18F\]F AraG PET signal before and after CkIT therapy, and to correlate this change in \[18F\]F AraG PET signal with a radiographic response.

Detailed description

Approximately 50 patients will undergo two research PET/CT scans with \[18F\]F AraG at two time points. Each patient will receive two 5 (+/-10%) mCi doses of \[18F\]F AraG, one for each imaging time point. Eligible subjects will undergo a pre-treatment \[18F\]F AraG PET/CT scan within 7 days prior to treatment, followed by treatment, and an on-treatment \[18F\]F AraG PET/CT within 7-14 days of treatment. Objectives: * Quantify \[18F\]F-AraG uptake in advanced NSCLC tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in patients treated with standard of care immunotherapy (as monotherapy or part of combination therapy). * Correlate change in \[18F\]F AraG uptake in tumor lesions with radiographic response.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	[18F]F AraG	PET imaging agent specific to activated T cells

Timeline

• Start date: 2021-04-15
• Primary completion: 2024-10-15
• Completion: 2024-10-15
• First posted: 2021-01-27
• Last updated: 2023-09-29

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study