Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.

Inclusion criteria

• Histological verified non-small cell lung cancer. Cytological diagnosis is accepted for doubtless results.
• Present stage IIIb with malignant pleural effusion or stage IV disease. Tumor dissemination should not be irradiable in one field
• Age between 18 and 75 years
• Karnofsky index 70 - 100%
• Measurable or evaluable tumor parameter
• No prior chemotherapy for NSCLC
• Sufficient hematological parameter before start of therapy (leucocytes > 3.500/µl and platelets > 100.000/µl).
• Sufficient liver function (bilirubin < 1,6mg/dl)
• Sufficient renal function (creatinine < 1,5mg/dl and clearance > 60ml/min)
• Minimal estimated life expectancy > 3 months
• Written informed consent for study attendance
• Patient accessibility for therapy and follow up
• No attendance to an other study

Exclusion criteria

• Small-cell lung cancer oder tumors with small-cell fractions
• Local advanced irradiable stage III
• Previous chemotherapy because of other diseases, not longer than 3 years ago
• Simultaneous radiation of all present tumor manifestations
• Simultaneous or not longer than 3 years ago secondary malignancy, except carcinoma in situ of the cervix or dermal cancer, others than melanoma
• Respiratory insufficiency
• Heart insufficiency NYHA III and IV
• Peripheral arteriosclerosis stage III and IV
• Neurological and psychiatric diseases, which affect understanding of the study concept and the possibility to keep conditions of the protocol
• Pregnancy, breastfeeding or not ensured contraception
• HIV-infection
• Active hepatitis B and C
• Manifest infectious diseases before start of therapy
• Minimal estimated life expectancy < 3 months
• No written informed consent of the patient for study attendance and storage and disclosure of disease data according to the protocol