Non Small Cell Lung Cancer Clinical Trial
Official title:
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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