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

University of California (UC) Davis

Status and phase: Withdrawn; Early Phase 1

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

Treatments: Drug: Fluorine F 18 Ara-G

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04186988

NCI-2019-07768 (Registry Identifier)

CCHO030 (Other Identifier)

1471901

P30CA093373 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• This study is open to all adult subjects with histological confirmation of NSCLC planned to undergo treatment with a PD-1 or PD-L1 inhibitor either as monotherapy or as combination therapy with concurrent chemotherapy as treatment for advanced/metastatic disease
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3 at the time of enrollment
• Patient with life expectancy >= 24 weeks from the time of screening to the study
• Ability to sign and understand the Institutional Review Board (IRB)-approved consent form in English
• Ability to remain motionless for up to 30 minutes per scan

Exclusion criteria

• Patients with severe claustrophobia (patients with milder forms of claustrophobia that can be successfully allayed with oral anxiolytic therapy are allowed)
• Severe impaired renal function with estimated glomerular filtration rate < 30 mL/min/1.73 m^2 and/or on dialysis
• Pregnancy
• Breast feeding an infant
• Prior treatment with anti-PD-1/PD-L1 inhibitor
• Localized/locally advanced disease with anti PD-1/PD-L1 given as consolidation

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Diagnostic ([18F]-AraG)

Experimental group

Description:

Patients receive \[18F\]-AraG 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.

Treatment:

Drug: Fluorine F 18 Ara-G