This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib plus docetaxel therapy versus docetaxel alone as second line treatment in patients with recurrent non-small cell lung cancer. Patients will be randomized to receive 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. The anticipated time on study treatment is until disease progression. Target sample size is 156. The main of this study is to determine the relevance of the association sequential erlotinib and docetaxel in terms of progression-free survival .
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
docetaxel :75 mg/m² IV day 1 every 3 weeks.
Service de Pneumologie, CHU Angers
Angers, France
Service de pneumologie; Centre Hospitalier d'Annecy
Annecy, France
Service de Pneumologie; Centre Hospitalier
Beauvais, France
Service de Pneumologie
Beauvais, France
Service de Pneumologie
Bordeaux, France
CHU Brest
Brest, France
Service de Pneumologie
Charleville Mezière, France
Service de Pneumologie ; Centre hospitalier
Charleville-Mézières, France
Service de Pneumologie
Créteil, France
Service de Pneumologie; Centre Hospitalier
Draguignan, France
...and 20 more locations
Progression Free Survival at 15 Weeks.
Time frame: at 15 weeks
Survival Rate at 12 Months
Time frame: 12 months
Overall Survival
Time frame: 12 mois
Progression-free Survival
Time frame: 12 months
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