Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.

Phase II Open-label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily or Twice Daily at 1250 mg as Second-line Monotherapy in Patients With Stage IIIB or Stage IV Non-small-cell Lung Cancer (NSCLC)

The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Inclusion Criteria:

• Non small cell lung cancer, Stage IIIB or Stage IV
• One and only 1 prior platinum-based chemotherapy
• No other uncontrolled concurrent illness
• Use of highly effective birth control methods in males or females with reproductive potential

Exclusion Criteria:

• Previous participation in another trial within the last 4 weeks
• Surgery within 10 days prior to the start of study treatment
• Brain metastases
• Confirmed diagnosis of infection with the human immunodeficiency virus (HIV)
• Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication
• Breast feeding