Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Inclusion Criteria:

1. Histology and staging of the disease

   * Histologically or cytologically confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC
   * Resectable or unresectable NSCLC stage II (T1-2 N1, T3 N0) or stage IIIa (T1-2 N2 or T3 N1-2) or stage IIIb (T1-3 N3 or T4 N0-3)
   * Measurable disease (bidimensionally or unidimensionally according to WHO criteria)
2. General conditions

   * Karnofsky Status \> 70, if age \> 70 years → PS \> 70
   * Adequate hematological function (Hb \> 10 g/dl, ANC \> 2.0 x 109/L, platelets \> 100 x 109/L)
   * Adequate renal and hepatic functions: total bilirubin \< 1 x upper normal limit (UNL), serum creatinine \< 1 x UNL, in case of limit value the creatinine clearance should be \> 60 ml/min, ASAT and ALAT \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL.

Exclusion Criteria:

1. Diagnosis

   * Evidence of brain metastases or other distant metastasis equivalent to stage IV disease
   * History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years
   * Other serious concomitant illness or medical condition:

     * Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia
     * History of significant neurologic or psychiatric disorders, including dementia or seizure
     * Active infection requiring i.v. Antibiotics
     * Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy
   * Hepatic function abnormality: ASAT and/or ALAT \> 1.5 x UNL associated with alkaline phosphatase \> 2.5 x UNL
   * Current peripheral neuropathy WHO grade \> 2
2. Prior or concurrent therapy

   * Prior chemotherapy or immunotherapy for NSCLC, including neoadjuvant or adjuvant treatment
   * Prior surgery or radiotherapy for NSCLC
   * Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy
3. General conditions

   * Pregnant or lactating patients
   * Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.