Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer

Summary

The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.

Timeline

Start

2003-08-14

Primary completion

2007-08-30

Completion

2007-08-30

Outcome

Missed primary endpoint

registry analysis (superiority test); IV Topotecan + IV Docetaxel vs IV Docetaxel; p = 0.9460; Hazard Ratio (HR) 1.007 (95% CI 0.813 to 1.248); Log Rank NCT00065182 ↗

Drugs

Indications