Erlotinib and Sequential Positron Emission Tomography (PET) in Advanced Non Small Cell Lung Cancer (NSCLC)

A Phase-II Clinical Trial to Evaluate the Accuracy of FDG-/FLT-PET for Early Prediction of Non-progression in Patients With Advanced NSCLC Treated With Erlotinib and to Associate PET Findings With Molecular Markers

This is a Phase-II Study to evaluate the accuracy of Fluorodeoxyglucose-/Fluorothymidine-Positron Emission Tomography (FDG-/FLT-PET) analyses for early prediction of non-progression in patients with non-small-cell lung cancer (NSCLC) treated with Erlotinib.

Inclusion Criteria:

• Written informed consent
• ≥ 18 years of age
• Untreated non-small-cell lung cancer stage IIIB/IV
• Life expectancy > 3 months
• Performance status ECOG 0-2

Exclusion Criteria:

• Concurrent systemic immune therapy, chemotherapy or therapy with any anticancer drug not indicated in the study protocol
• Any investigational agent(s) within 4 weeks prior to study entry
• Previous administration of any EGFR-targeted therapy (antibodies, small molecules and others)
• Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information