Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
advanced Non-Small-Cell Lung Cancer, erlotinib, FDG-PET, FLT-PET
Brief summary
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.
Interventions
DRUGerlotinib
erlotinib p.o. (by mouth), 150 mg once daily for week 1-6 (day 1-42)
PROCEDUREFDG-/FLT-PET
Sponsors
Lung Cancer Group Cologne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the accuracy of FDG-/FLT-PET analyses for early prediction of non-progression in patients with NSCLC treated with Erlotinib | 34 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 34 months |
Countries
Germany
Outcome results
None listed