drugset / Trial / NCT00453362

A Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib

NCT00453362 ↗

Phase 1/2 Completed 88 enrolled Genentech, Inc. Roche Pharma AG · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm, open-label, multicenter, international pilot study to evaluate changes that occur in 2-deoxy-2-\[18F\]fluoro-D-glucose (FDG)- and 3'-deoxy-3'-\[18F\]fluorothymidine(FLT)-PET (Positron Emission Tomography) imaging as a result of treatment with erlotinib in patients with recurrent or refractory non-small cell lung cancer (NSCLC). The study will enroll approximately 30 patients at approximately 4 sites in Australia and 2 sites in the United States.

Timeline

Start
2006-12
Primary completion
2010-04
Completion
2010-04-23

Outcome

Mixed primary results

registry Erlotinib_FDG Responders vs Erlotinib_ FDG Non-Responders; p = 0.017; Hazard Ratio (HR) 0.31 (95% CI 0.11 to 0.87); Log Rank NCT00453362 ↗

registry Erlotinib_FDG Responders With CT SD at Day 56 vs Erlotinib_FDG Progressive Disease With CT SD at Day 56; p = 0.076; Hazard Ratio (HR) 0.3 (95% CI 0.06 to 1.42); Log Rank NCT00453362 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg Oral