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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellSight Technologies, Inc.

About this trial

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 criteria

Qualifiers

Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease.

Measurable disease.

ECOG performance status of 0, 1 or 2.

Subjects are willing to be followed at the University of Iowa.

Disqualifiers

Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.

Pregnant women or nursing mothers.

Patients with severe claustrophobia.

Trial design

Treatments tested in this trial

  • [18F]F-AraG

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators