Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California
Dates
study started
estimated completion
Principal Investigator
Julie Sutcliffe

Description

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.

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

Details

PRIMARY OBJECTIVES:

  1. 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.

Keywords

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 Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung 9-arabinofuranosylguanine Fluorine F 18 Ara-G

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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 m2 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

Location

  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UC Davis

  • Julie Sutcliffe
    Professor, Hematology and Oncology. Authored (or co-authored) 55 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT04186988
Phase
Phase 1
Study Type
Interventional
Last Updated