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A Phase I/IB Trial of MEK162 in Combination with Erlotinib in NSCLC Harboring KRAS or EGFR Mutation
The main purpose of this study is to find out if the drugs MEK162 and erlotinib (Tarceva) given in combination are safe and have beneficial effects in patients who have NSCLC. MEK162 is a medicine which has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of people with your medical condition. The medicine being tested in this study is currently not "on the market" (available for you to buy) in any country. Erlotinib is an FDA approved drug for the treatment of Non-Small Cell Lung Cancer.
Phase I Primary Objective: To evaluate the safety of MEK162 plus erlotinib in patients with advanced NSCLC by evaluating toxicities of therapy and establish a recommended phase IB dosing of MEK162 and erlotinib. Phase IB Expansion Cohort Primary Objective: To evaluate the safety of MEK162 + erlotinib in patients specifically with advanced EGFR mutant or KRAS mutant NSCLC.