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

This is an interventional treatment trial for Non Small Cell Lung Cancer Read More

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