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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04726215

Enrollment

Registered

2021-01-27

Start date

2021-04-15

Completion date

2024-10-15

Last updated

2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

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.

Interventions

DRUG[18F]F AraG

PET imaging agent specific to activated T cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
[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

Countries

United States

Contacts

Primary ContactSAMUEL QUEZADA

squezada@cellsighttech.com6507991589

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026