Background: Ficlatuzumab is a humanized anti-HGF IgG1 MAb that inhibits activation of the c-Met receptor by neutralizing its only known natural ligand, HGF. HGF/c-Met pathway activation has been implicated in EGFR TKI resistance in NSCLC. In an ongoing phase Ib trial, the combination of ficlatuzumab + G was found to be well tolerated up to the maximum tested dose of 20 mg/kg of ficlatuzumab and 250 mg of G, and demonstrated clinical activity in pts with NSCLC. Methods: It is a multi-center, open-label, 2-arm, randomized study comparing ficlatuzumab + G versus G alone in clinically selected Asian pts with previously untreated lung adenocarcinoma (never- or former-light smokers) who have a high likelihood of harboring activating EGFR mutations. Stratification is by ECOG performance status (0-1 vs. 2), smoking status (nonsmoker vs. light ex-smoker) and gender. Pts will be treated in continuous 28-day cycles, during which all pts will receive G daily (250 mg/day PO), and pts randomized to ficlatuzumab + G will also receive ficlatuzumab (20 mg/kg IV) on Days 1 and 15 of each cycle. Pts who progress after achieving initial disease control (CR, PR, or SD for 12 weeks or longer) in the G alone arm may cross over to the combination arm. The primary objective is to compare the Objective Response Rate (ORR) between the arms. Secondary objectives are to evaluate the safety and tolerability of ficlatuzumab + G, response duration, Progression-Free Survival (PFS), and Overall Survival (OS), to investigate the relationship between the anti-tumor activity of ficlatuzumab + G and molecular markers such as activating EGFR mutations, c‑Met and EGFR gene copy numbers (FISH positivity), HGF, c-Met and p-Met expression, HGF serum levels, and to assess whether acquired resistance to G can be overcome with the addition of ficlatuzumab in pts who progressed after initial demonstration of disease control (CR, PR, or SD for 12 weeks or longer) in the G alone arm. Estimated sample size is 170 pts.