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A Phase II Trial of AZD9291 (Osimertinib) with or without Bevacizumab in Patients with EGFR Mutation Positive NSCLC and Brain Metastases
The purpose of this study is to see how well osimertinib, with or without bevacizumab works in treating patients with epidermal growth factor receptor(EGFR) positive non-small cell lung cancer (NSCLC) that has spread to the brain.
Primary Objectives: To determine the progression-free survival with AZD9291 (osimertinib) plus bevacizumab compared to AZD9291 (osimertinib) alone. Secondary Objectives: To assess the safety and tolerability of the combination of AZD9291(osimertinib) and bevacizumab. To evaluate the time to progression in the CNS with AZD9291 (osimertinib) plus bevacizumab versus single-agent osimertinib. To determine the overall response rate and the intracranial response rate to the combination versus single agent. To assess the overall survival in patients receiving AZD9291 (osimertinib) plus bevacizumab compared to AZD9291 (osimertinib) alone.