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

Phase 2

Recruiting

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT04726215
• Lead Sponsor: CellSight Technologies, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-27
• Study Start: 2021-04-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients with a histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy with concurrent as treatment for advanced/metastatic disease.
2. RECIST measurable disease.
3. ECOG performance status of 0, 1 or 2.
4. Life expectancy >/= 6 months at enrollment.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
[18F]F-AraG uptake signal	two years	\[18F\]F-AraG uptake signal will be measured quantitatively by SUV-bw of the tumor volumes of interest before and after undergoing treatment

Trial Locations

Locations (3)

Sutter Cancer Center; 🇺🇸 Sacramento, California, United States

Palo Alto Veterans Institute of Research; 🇺🇸 Palo Alto, California, United States

Stony Brook University; 🇺🇸 Stony Brook, New York, United States