Erlotinib and Sequential Positron Emission Tomography (PET) in Advanced Non Small Cell Lung Cancer (NSCLC)
This trial is active, not recruiting.
|Condition||carcinoma, non-small-cell lung|
|Sponsor||Lung Cancer Group Cologne|
|Start date||October 2007|
|End date||December 2009|
|Trial size||40 participants|
|Trial identifier||NCT00568841, 06159, 2005-005393-73|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Intervention model||single group assignment|
To evaluate the accuracy of FDG-/FLT-PET analyses for early prediction of non-progression in patients with NSCLC treated with Erlotinib
time frame: 34 months
To identify PET characteristics for progression, response and stable disease; To identify EGFR and KRAS sequence characteristics for clinical response and stable disease; Safety; Response rates; One-year FFTF; One-year OS; Median overall survival time
time frame: 34 months
Male or female participants at least 18 years old.
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
|Official title||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|
|Principal investigator||Juergen Wolf, Prof., Dr.|
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