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
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- CellSight Technologies, Inc.
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- [18F]F-AraG uptake signal
Study Overview
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.
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
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
[18F]F-AraG uptake signal
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported