A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer

Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)

The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their lung cancer

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:

• Small-cell lung cancer
• Stage of extensive disease
• Adequate function of major organs and systems
• Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

• Prior chemotherapy for small-cell lung cancer
• Prior surgical resection or radiotherapy for SCLC within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases
• Superior vena cava syndrome or obstruction of any vital structure
• Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation
• Known allergy or hypersensitivity to platinum-containing drugs
• Pregnancy or breast-feeding
• Use of any investigational drug within 4 weeks before start of the study