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

NCT04186988 | Withdrawn Early Phase 1 DMC FDA Drug

• 4 other identifiers: 1471901NCI-2019-07768CCHO030P30CA093373
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  The positron emission tomography (PET) images will be interpreted qualitatively and semi-quantitatively on a lesion-by-lesion basis. Semi-quantitative analysis will be employed as follows: (a) Regions of interest (ROIs) will be placed around tracer avid foci suspicious for malignancy in order to obtain standardized uptake value (SUV) parameters, including maximum SUV (SUVmax), SUVpeak, SUVmean; (b) SUV data will be recorded along with volumetric and positional information in a standardized form.

  Baseline up to within 2 weeks after starting immunotherapy

Secondary Outcomes (2)

• Mean change in SUV

  Baseline up to within 2 weeks after starting immunotherapy

• Correlation between [18F]-AraG uptake and clinical response

  Baseline up to within 2 weeks after starting immunotherapy

Study Arms (1)

Diagnostic ([18F]-AraG)

EXPERIMENTAL

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.

Drug: Fluorine F 18 Ara-G

Interventions

Fluorine F 18 Ara-G DRUG

Given IV

Also known as: 18F-F-Ara-G, [18F]F-ara-G, [18F]F-AraG

Diagnostic ([18F]-AraG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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 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

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator
• CellSight Technologies, Inc.: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Julie Sutcliffe

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 5, 2019
• Study Start: November 5, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: February 1, 2022

Record last verified: 2022-01