Docetaxel Combined With Cisplatin as First Line in Patients With Metastatic Non-small Cell Lung Cancer

Inclusion Criteria:

* Histologically or cytologically proven non-small cell lung carcinoma
* Stage IV metastatic non-small cell lung carcinoma or stage III with malignant pleural effusion.
* Patient should not be eligible for customization chemotherapy (if available at participating institutions).
* Having at least one measurable lesion
* Patient has life expectancy of 12 weeks or greater.
* Age \> 18 years.
* No prior systemic treatment for metastatic lung cancer. Adjuvant treatment given more than 1 year ago is acceptable.
* WHO performance status 0-2 (See Appendix III )
* Adequate organ function:

  * Hematology: Neutrophils \> 2 x 10 9 /L, platelets \> 100 x 10 9 /L
  * Hepatic function: Total bilirubin \< 1.25 times the upper normal limits, ASAT (SGOT) \< 2 times the upper normal limits
  * Renal function: Creatinine \< 1.5 mg/dL; if value is higher than upper normal limit but less than 2 mg/dL, the creatinine clearance should be \> 60min/ml.
* Able to comply with scheduled follow-up and with management of toxicity
* Signed informed consent from patient or legal representative
* Negative urine pregnancy test (if indicated)

Exclusion Criteria:

* Pregnant or lactating women or women of childbearing potential using inadequate contraception.
* Uncontrolled brain metastatic disease. (CNS disease that is stable \> 4 weeks after radiotherapy in lieu of steroids reduction is eligible).
* Symptomatic peripheral neuropathy \> grade 1 according to the NCI Common Toxicity Criteria Version 3
* Other serious illness or medical condition:

  * Unstable cardiac disease requiring treatment
  * History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures
  * Active uncontrolled infection
* Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening
* Concurrent treatment with any other anti-cancer therapy
* Contraindication of steroid drug administration
* Past (up to 5 years) or concurrent history of other neoplasm except curatively treated non- melanoma skin cancer or in situ carcinoma of the cervix