Clinical trial 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
Official title: Imaging of T-Cell Activation With [18F]-AraG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1/PD-L1-Directed Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
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
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: CellSight Technologies, Inc.
First posted: 2019-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fluorine F 18 Ara-G ([18F]-AraG) uptake values in advanced non-small cell lung cancer (NSCLC) before and after treatment with anti-PD-1/PD-L1 therapy obtained
timeFrame: Baseline up to within 2 weeks after starting immunotherapy
Secondary outcomes:
measure: Mean change in SUV
timeFrame: Baseline up to within 2 weeks after starting immunotherapy
measure: Correlation between [18F]-AraG uptake and clinical response
timeFrame: Baseline up to within 2 weeks after starting immunotherapy
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis
name: Julie Sutcliffe
role: PRINCIPAL_INVESTIGATOR
References: