Taxotere-Enoxaparin-(ENOXA)-Study

Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as Single Therapy or in Combination With Enoxaparin in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, a Phase III Study

Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as single therapy or in combination with Enoxaparin in patients aged older than 18 years with locally advanced or metastatic non-small cell lung cancer (stadium IIIb/IV), a phase III study. Study hypothesis: Increase of progressive free survival from 5 to 7.5 months.

Inclusion Criteria:

• Signed informed consent
• Men and women aged 18 and older
• Locally Advanced or Metastatic Non-small Cell Lung Cancer stage IIIB/IV without any previous therapy
• Life expectancy at least 12 weeks
• EOCG performance < 1
• Appropriate renal and hepatic function
• Appropriate Hematology
• No bleeding events within 4 weeks prior to randomization
• No indication for prophylactic or therapeutic anticoagulation therapy
• Appropriate methods of contraception (both: men and women) for women of childbearing potential negative urine pregnancy test within 7 day prior to randomization
• Capability for s.c. injection of Enoxaparin every 24 hrs

Exclusion Criteria:

• History of cancer other than NSCLC
• Known contraindication for Enoxaparin e.g. HIT,
• Known contraindication for Docetaxel, Cisplatin, Carboplatin or co-medication
• Participation in any other clinical trials within 30 days prior to randomization
• Any known medical condition that does not allow therapy according to study protocol
• Seizure disorder