Overview

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

Status:
Recruiting
Trial end date:
2023-05-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CellSight Technologies, Inc.
Criteria
Inclusion Criteria:

1. 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.

2. RECIST measurable disease.

3. ECOG performance status of 0, 1 or 2.

4. Life expectancy >/= 6 months at enrollment.

Exclusion Criteria:

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

2. Pregnant women or nursing mothers.

3. Patients with severe claustrophobia.