At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed NSCLC
- ✓Recurrent or progressive disease after ≥1 chemotherapy regimen for advanced or metastatic NSCLC
- ✓ECOG performance status 0, 1, or 2
- ✓Age ≥18 years
- ✕Prior EGFR inhibitor treatment (erlotinib, gefitinib, or other EGFR inhibitors)
- ✕Chemotherapy, radiotherapy, or investigational treatment within 14 days or 5 half-lives (whichever longer) prior to study entry
- ✕Inability to take oral medications or disease/procedure affecting GI absorption
- ✕Uncontrolled diabetes
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Study of Changes in FDG- and FLT-PET Imaging in Patients With Non-Small Cell Lung Cancer Following Treatment With Erlotinib
In Brief
A Phase 2 clinical trial evaluating 2-deoxy-2-[18F]fluoro-D-glucose (FDG), 3'-deoxy-3'-[18F]fluorothymidine (FLT), and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 88 participants.
Detailed 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.
Study Details
Timeline
Interventions
FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie).
FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection.
Tablets taken orally 150 mg/day.