PET Imaging With [18F]F-AraG in Advanced Non-small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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This is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called [18F]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).

Detailed Description
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The purpose of this study is to find out how the radiotracer called [18F]F-AraG can help investigate changes in cancer's anti-tumor immune response (or activation of T-cell) levels during positron emission tomography (PET) scans. [18F]F-AraG has the potential to serve as a noninvasive imaging biomarker in the monitoring of T-cell mediated anti-tumor immune response following administration of an immunotherapeutic agent. Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include about three clinic visits. A baseline [18F]F-AraG PET-CT will be obtained 0-7 days before a NSCLC patient receives PD-1/PD-L1 immunotherapy. A second [18F]F-AraG PET-CT will be performed 10-14 days after PD-1/PD-L1 immunotherapy is administered.

Official Title
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A Study of PET 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

Conditions
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Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Drug: [18F]F-AraG Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older and willing and able to provide informed consent. Subjects with stage I, II, or III A NSCLC and plan to receive neoadjuvant PD-1/PD-L1 immunotherapy with an intention for curative surgery. Subjects will be receiving neoadjuvant immunotherapy through enrollment in therapeutic clinical trials Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at the time of enrollment. For females of childbearing potential, negative serum pregnancy test within a 10 day period will be obtained prior to PET study. Exclusion Criteria: Severe impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73 m2 and/or on dialysis. Pregnant female patients; breastfeeding female patients. Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject. Any investigational radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem. Administered a radioisotope ≤5 physical half-lives prior to the day of PET/CT.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F]F-AraG<br>A one-time nominal injection dose of 5 millicurie (mCi) +/- will be administered at each PET/CT imaging time point. | Drug: [18F]F-AraG Injection<br>* Single dose of 5 mCi+/- [18F]F-AraG IV injection followed by the PET/CT scan. A baseline [18F]F-AraG PET/CT will be performed at about 0-7 days before patient receives the first dose of PD-1/PD-L1 immunotherapy. A second [18F]F-AraG PET-CT will be performed at less than 14 days after the first dose of PD-1/PD-L1 immunotherapy is administered and before the second dose of PD-1/PD-L1 immunotherapy is given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1 | Percent Change in standard uptake value (SUV) of [18F]F-AraG PET-CT imaging of primary tumor and of lymph nodes at baseline to after the first dose of neoadjuvant therapy. | Baseline and 10-14 days after first dose of neoadjuvant therapy | 
| Percent pathologic response at the time of surgery | 100% minus the percentage of viable tumor remaining in the tumor bed. | At the time of surgery | 
| Correlation between [18F]F-AraG uptake and percent pathologic response as assessed by the Spearman correlation coefficient | Spearman correlation coefficient will be calculated in assessing the correlation between [18F]F-AraG uptake and pathologic response. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD-1, PD-L1, immunotherapy, J19119, PET/CT, [18F]F-AraG, NSCLC