Non Small Cell Lung Cancer Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 15, 2024 |
Est. primary completion date | October 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Palo Alto Veterans Institute of Research | Palo Alto | California |
United States | Sutter Cancer Center | Sacramento | California |
United States | Stony Brook University | Stony Brook | New York |
Lead Sponsor | Collaborator |
---|---|
CellSight Technologies, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | [18F]F-AraG uptake signal | [18F]F-AraG uptake signal will be measured quantitatively by SUV-bw of the tumor volumes of interest before and after undergoing treatment | two years |
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