Phase III trial (E5592) comparing cisplatin plus etoposide with cisplatin plus paclitaxel at two dose levels for treatment of advanced non-small-cell lung cancer. Eastern Cooperative Oncology Group.

Non-small-cell lung cancer (NSCLC) is the most common cause of cancer-related death in the United States. Only about 30% of patients present with surgically resectable (and thus curable) disease. Because existing chemotherapeutic regimens are never curative in advanced NSCLC and because the median survival time is only modestly increased, the Eastern Cooperative Oncology Group (ECOG) has concentrated on a broad phase II testing program designed to identify new agents with activity against the disease. Of the more than one dozen drugs that have been thus evaluated during the past 10 years, only paclitaxel (Taxol) has been shown to result in an objective response rate of more than 20%. To determine if the paclitaxel-containing regimen can increase survival, ECOG has, therefore, embarked on a phase III trial (E5592) in which patients with stage IV NSCLC are randomly assigned to receive either cisplatin plus etoposide (the current standard chemotherapy) or cisplatin plus paclitaxel. The trial design should also help to determine the appropriate dose of paclitaxel in this clinical setting.