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

C

CellSight Technologies

Status and phase

Enrolling
Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: [18F]F AraG

Study type

Interventional

Funder types

Industry

Identifiers

NCT04726215
CST-FARAG-IO-MULT-201

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

3

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Central trial contact

SAMUEL QUEZADA

Data sourced from clinicaltrials.gov

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