A Phase II Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease

OBJECTIVES:

Primary

• Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy.

Secondary

• Determine the safety of this drug in these patients.
• Determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug.
• Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment.
• Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients.