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An Open-Label Randomized Phase II Study of Combining Osimertinib with and without Ramucirumab in TKI-naïve EGFR-mutant Locally Advanced or Metastatic NSCLC
The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.
Primary Objective: Determine whether, in patients with TKI-naïve locally advanced or metastatic EGFR mutant NSCLC the addition of ramucirumab to osimertinib improves progression free survival, compared to osimertinib alone Secondary Objectives: Determine whether osimertinib plus ramucirumab improves objective response rate (ORR) compared with osimertinib alone. Determine whether osimertinib plus ramucirumab improves overall survival (OS) compared with osimertinib alone. Determine whether osimertinib plus ramucirumab improves disease control rate (DCR) compared with osimertinib alone. Determine the safety and tolerability of combining osimertinib with ramucirumab compared with osimertinib alone.