 The Phase 2 is an open-label, 2-arm, randomized study designed to compare the combination of AV-299 formerly SCH900105 and gefitinib versus gefitinib alone in clinically selected Asian subjects with previously untreated lung adenocarcinoma who have a high likelihood of harboring activating EGFR mutations. Subjects who progress after initial disease control in the gefitinib alone arm may crossover to the combination arm. 