First-Line EGFR-1 Tyrosine Kinase Inhibition in Patients With NSCLC With Mutant EGFR Gene
Recruitment status was: Recruiting
Current chemotherapy for advanced non-small cell lung cancer, not amenable for curative local treatment (surgery or chemoradiotherapy), has a modest life-prolonging effect and can improve quality of life. There is however no potential for long-term cure for these patients.
Chemotherapy also produces variable and often significant toxicity. Current retrospective evidence suggests that significant clinical responses can be obtained when patients whose cancer cells have an EGFR TKD mutation are treated with an EGFR TKI.
The ease of administration and toxicity profile of TKI compare favourably with that of chemotherapy, even single agents such as for example gemcitabine The present study will establish the clinical benefit rate of TKI as a first line treatment in patients with EGFR mutations and thus estimate the proportion of patients who might benefit for a prolonged period from a treatment with a modest toxicity profile.
Non-Small Cell Lung Cancer
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Evaluation of Small Molecule EGFR-1 Tyrosine Kinase Inhibition as a First-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Harbouring a Mutant EGFR Gene|
- Establish clinical benefit (progression free survival) of first line RTKI in patients with stage IV and stage IIIB NSCLC not eligible for curative-intent treatment (chemo-radiotherapy) carrying a mutant EGFR-1.
- Determine response rate (OR and stable disease) and duration under erlotinib treatment.
- Determine the effect on Quality of Life (QOL) of first-line anti-EGFR-1 treatment.
- Determine the value of positron emission tomography (PET)-scan as an early predictor of response and clinical benefit.
- Overall survival from the time of study entry to the date of death or date of last follow-up.
- Determine biological correlates for response/resistance in tumour tissues.
|Study Start Date:||January 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00339586
|Jette, Belgium, 1090|
|Principal Investigator:||Jacques De Grève, MD PhD||AZ-VUB|