Trial Information
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
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
To evaluate the accuracy of FDG-/FLT-PET analyses for early prediction of non-progression in patients with NSCLC treated with Erlotinib
Outcome Time Frame:
34 months
Safety Issue:
Yes
Principal Investigator
Juergen Wolf, Prof., Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Cologne, Lung Cancer Group Cologne
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
2005-005393-73
NCT ID:
NCT00568841
Start Date:
October 2007
Completion Date:
December 2009
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- advanced Non-Small-Cell Lung Cancer
- erlotinib
- FDG-PET
- FLT-PET
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms