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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726215
• Other study ID #: CST-FARAG-IO-MULT-201
• Status: Recruiting
• Phase: Phase 2
• Start date: April 15, 2021
• Est. completion date: October 15, 2024

Study information

• Verified date: September 2023
• Source: CellSight Technologies, Inc.
• Contact: SAMUEL QUEZADA
• Phone: 6507991589
• Email: squezada[@]cellsighttech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• [18F]F AraG
PET imaging agent specific to activated T cells

Locations

Country	Name	City	State
United States	Palo Alto Veterans Institute of Research	Palo Alto	California
United States	Sutter Cancer Center	Sacramento	California
United States	Stony Brook University	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
CellSight Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[18F]F-AraG uptake signal	[18F]F-AraG uptake signal will be measured quantitatively by SUV-bw of the tumor volumes of interest before and after undergoing treatment	two years