Pemetrexed in small-cell lung cancer: background and review of the ongoing GALES pivotal trial.

Abstract

Pemetrexed is a novel, multitargeted antifolate currently under development for the treatment of a number of solid tumors, including small-cell lung cancer. Pemetrexed/platinum combinations appear to compare favorably with other platinum-based doublets in terms of their efficacy and safety profile. The Global Analysis of Pemetrexed in SCLC Extensive Stage (GALES) trial is a direct comparison of pemetrexed and carboplatin with the standard first-line etoposide and carboplatin chemotherapy in extensive-disease small-cell lung cancer. This randomized, multicenter, open-label Phase III study will enroll 1820 patients in 23 countries, with the final analysis planned after 1270 deaths have occurred. An interim analysis will be conducted after 700 patients have been enrolled. The study will also use pharmacogenomic analysis to evaluate biological predictors of response, in particular to pemetrexed.