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A Phase 1 Trial of MLN0128 (TAK-228) in Combination with Osimertinib (AZD9291) in Advanced EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC) After Progression on a Previous EGFR Tyrosine Kinase Inhibitor
The purpose of this study is to test the safety of two investigational drugs, MLN0128 (TAK-228) and AZD9291 when given together. MLN0128 (TAK-228) is experimental and AZD9291(osimertinib) is approved by the FDA for lung cancer treatment by itself. Both drugs have been tested in humans but combining MLN0128 (TAK-228) and AZD9291 together has not been tested in humans. This study tests different doses of the drugs to see which dose is safer in people with lung cancer.
Primary Objectives: - Dose Escalation Phase: To determine the safety and recommended phase II dose (RP2D) of MLN0128 (TAK-228) in combination with osimertinib (AZD9291) in patients with advanced EGFRm NSCLC and who are resistant to previous EGFR-TKI therapy. - Dose Expansion Phase: To evaluate the safety and preliminary efficacy of MLN0128 (TAK-228) in combination with osimertinib (AZD9291) in patients with advanced EGFRm NSCLC that is negative for the resistance mutation T790M (T790M-) and who are resistant to previous EGFR-TKI therapy. Secondary Objectives: - To evaluate pharmacokinetic profiles of MLN0128 (TAK-228) in combination with osimertinib (AZD9291). - To evaluate the response rate, disease control rate and progression free survival of the combination. - To explore biomarkers of response and resistance to the combination by studying baseline biopsies, resistance biopsies, and serial plasma DNA specimens.