[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 logo

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Withdrawn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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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