Docetaxel Intermittent-Erlotinib (Tarceva®) In Metastatic Non Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

• •1. Male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic NSCLC will be enrolled.
• •2. Patients must have not been previously treated with anticancer drugs for advanced disease.
• •3. ECOG performance status of 0 - 1.
• •4. Life expectancy of at least 12 weeks.
• •5. Patients must be able to take oral medication.
• •6. At least 4 weeks since any prior major surgery or extended-field radiotherapy. Patients who, in the opinion of the investigator, have fully recovered from limited surgery or have undergone limited-field radiotherapy within 2 weeks may also be considered eligible for the study
• •7. Granulocyte count \> 1,500/mm3 and platelet count \> 100,000/mm3. Haemoglobin ³ 9.0g/dl.
• •8. SGOT (AST) and SGPT (ALT) \< 2,5 x ULN in the absence of liver metastases or up to 5 x ULN in case of liver metastases
• •9. Alkaline phosphatase (ALP) \< 2,5 x ULN. If alkaline phosphatase is \> 2.5 x ULN, SGOT (AST) and SGPT (ALT) must be \< 1.5 x ULN. If alkaline phosphatase is ³ 2.5 x ULN in the presence of liver metastases, SGOT and SGPT must be \< 5 x ULN
• •10. Serum creatinine \<= 1.5 ULN or creatinine clearance \> 60 ml/min.
• •11. Normal serum calcium.
• •12. For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting Tarceva/placebo treatment.
• •13. Patients with reproductive potential must use effective contraception.
• •14. Able to comply with study and follow-up procedures.
• •15. Written (signed) Informed Consent to participate in the study.
• •16. Written (signed) Informed Consent for use of tumour samples.
• •17. Presence of measurable or evaluable disease (lesions that are present but do not fulfil the criteria for measurable disease).
• •18. Formalin-fixed, paraffin-embedded tumour tissue samples representative of the tumour will be provided to sponsor within 3 weeks of the patient starting chemotherapy