Randomized Open Non Comparative Multicenter Phase II Study of Sequential Erlotinib With Docetaxel Versus Docetaxel Alone in Second Line of Treatment in Patients With Non Small Cell Lung Cancer After Failure of First Line Chemotherapy
In this study, the patient will be randomized in group 1(experimental arm): docetaxel :75
mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 and group 2 (control
arm): docetaxel :75 mg/m² IV day 1 every 3 weeks.
Assessment during treatment: Physical examination, ECG,: every 3 weeks, laboratory tests:
weekly, every 3 weeks pulmonary X-ray .The CT scans:. Measurable targets are assessed by
RECIST compared to the beginning of treatment: at 6 weeks (day 42 EVA 2), 12 weeks (D84 EVA
3), 15 weeks (D105 EVA 4: Evaluation of the SSP) and then every 6 weeks until progression.
Quality of life will be assessed Day 42 then every 6 weeks during chemotherapy, Tolerability
will be assessed at each visit based on CTC v4.0 criteria.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival at 15 weeks.
at 15 weeks
Alain Vergnengre, MD
University Hospital, Limoges
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)