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

Sponsor

CellSight Technologies, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04726215

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

16.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: [18F]F AraG	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Apr 15, 2023

Anticipated Study Completion Date :

May 15, 2023

Outcome Measures

Primary Outcome Measures

[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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
RECIST measurable disease.
ECOG performance status of 0, 1 or 2.
Life expectancy >/= 6 months at enrollment.

Exclusion Criteria:

Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
Pregnant women or nursing mothers.
Patients with severe claustrophobia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Alto Veterans Institute of Research	Palo Alto	California	United States	94304
2	Sutter Cancer Center	Sacramento	California	United States	95816
3	Stony Brook University	Stony Brook	New York	United States	11794

Sponsors and Collaborators

CellSight Technologies, Inc.

Investigators

Principal Investigator: Deepak Behera, MD, CellSight Technologies, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CellSight Technologies, Inc.

ClinicalTrials.gov Identifier:

NCT04726215

Other Study ID Numbers:

CST-FARAG-IO-MULT-201

First Posted:

Jan 27, 2021

Last Update Posted:

Apr 13, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Apr 13, 2022