Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer

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.

Inclusion criteria

• Histologically proven NSCLC (
• Mutational status of EGFR : wild type or unknown
• Stage IV disease with cytologic or histologic documentation in patients with a single easily accessible metastasis or metastatic relapses in a non irradiated region from a primary tumor treated with surgery or radiotherapy (with cytologic or histologic documentation of relapse)
• Presence of at least one measurable target lesion (one dimension) in a non irradiated region (at least 10 mm on spiral computed tomography).
• Age ≥ 18 years
• Performance status 0,1,2 exception : age > 74 years only PS 0 or 1
• Normal hepatic function
• Normal renal function
• Normal calcemia
• Normal haematological function
• Life expectancy > 12 weeks.
• Women of child bearing potential must use effective contraception.
• Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment.
• Written informed consent to participate in the study.

Exclusion criteria

• PS > 2, exception : age > 74 years only PS ≥ 2
• Presence of another cancer
• Previous treatment with an anti egfr agent or docetaxel
• QT prolongation (>470 ms)
• Uncontrolled arterial hypertension.
• Concurrent radiotherapy, except for palliative bone irradiation.
• Stroke less than 6 months before study entry.
• Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial
• Uncontrolled infection.
• Caval syndrome
• Other organic disorders preventing inclusion in the trial
• Malabsorption syndrome
• Allergy to erlotinib or one of its constituents
• Allergy to docetaxel or one of its constituents
• Pregnancy and breast-feeding
• Surgery less than two months before study entry