RecruitingPhase 2NCT06107374

Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG

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

Sponsor

CellSight Technologies, Inc.

Enrollment

20 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Non-Small Cell Lung Cancer

Summary

This pilot study uses \[18F\]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in \[18F\]F AraG PET signal before and while on CkIT therapy and to correlate this change in \[18F\]F AraG PET signal with radiographic response. To explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment \[18F\]F AraG PET/CT scans, and will be followed up for 12 months for assessment of radiographic and clinical outcomes. This study is a single-site, open label, non randomized, single arm pilot trial. Patients and care providers will not be blinded to any part of the study.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This imaging study is using a new PET scan tracer called [18F]-FARAG to see how well it can visualize and track immune activity in advanced non-small cell lung cancer (NSCLC) tumors during treatment with immunotherapy (PD-1/PD-L1 checkpoint inhibitors). The goal is to find better ways to predict which patients respond to immunotherapy. **You may be eligible if...** - You have confirmed non-small cell lung cancer (NSCLC) with advanced or metastatic disease - You are planned to receive immunotherapy (PD-1 or PD-L1 directed) as monotherapy or in combination - You have at least one measurable tumor - Your general health is adequate (ECOG 0–2) - You are followed at the University of Iowa **You may NOT be eligible if...** - You have serious health conditions that in the investigator's opinion would interfere with the study - You are pregnant or breastfeeding - You have severe claustrophobia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[18F]F-AraG

Two PET scans

Locations(1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

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NCT06107374

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