NCT04186988

[18F]-AraG for the Detection of T-Cell Activation in Advanced Non-small Cell Lung Cancer Patients Undergoing PD-1/PD-L1-Directed Therapy

Imaging of T-Cell Activation With [18F]-AraG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-Directed Therapy

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well \[18F\]-AraG works in detecting T-cell activation in patients with non-small cell lung cancer that has spread to other places in the body (advanced), who are undergoing PD-1/PD-L1-directed therapy. \[18F\]-AraG is a "radiotracer" which attaches to immune cells directed at the cancer and shines a light that can be seen using a special camera, called a "positron emission tomography" or "PET" scanner. \[18F\]-AraG may improve the ability to detect a response of the cancer in the body to immunotherapy.

Detailed description

PRIMARY OBJECTIVES: I. To quantify fluorine F 18 Ara-G (\[18F\]-AraG) uptake (standardized uptake value \[SUV\]) in advanced non-small cell lung cancer (NSCLC) tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in both patients treated with PD-1/PD-L1 monotherapy and in patients treated with immunotherapy/chemotherapy combination therapy. II. To correlate change in \[18F\]-AraG uptake before and after the start of therapy with radiographic response in patients treated with immunotherapy. OUTLINE: Patients receive \[18F\]-AraG intravenously (IV) and then undergo PET/CT over 2 hours at baseline and within 2 weeks after starting immunotherapy. Patients may also undergo blood sample collection. After completion of study treatment, patients are followed for up to 12 months.

Conditions

• Advanced Lung Non-Small Cell Carcinoma
• Metastatic Lung Non-Small Cell Carcinoma
• Stage III Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Fluorine F 18 Ara-G	Given IV

Timeline

• Start date: 2019-11-05
• Primary completion: 2020-03-12
• Completion: 2020-03-12
• First posted: 2019-12-05
• Last updated: 2022-02-01

Regulatory

• FDA-regulated drug study