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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Contact Information
Primary
Amy Mundisev
amy-mundisev@uiowa.edu
319-356-1445
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 20
Treatments
Experimental: Advanced non small cell lung cancer (NSCLC) patients undergoing PD-1/PD-L1 directed therapy
Sponsors
Leads: CellSight Technologies, Inc.

This content was sourced from clinicaltrials.gov