Phase I - Two arms (Monotherapy and Combination therapy) with primary endpoints of Dose Limiting Toxicity Phase II - Two arms Monotherapy Cohort: Primary endpoint is Intracranial Objective Response Rate Combination Cohort: Primary endpoint is overall and extracranial Objective Response Rate among patients treated with the combination of tepotinib and concurrent TKI.
This study will look at how effective the study drug (tepotinib) is at stopping the growth and spread of lung cancer with central nervous system metastasis. In some patients, who have developed resistance to their tyrosine kinase inhibitors (TKIs), this study will look at how effective tepotinib is in combination with TKIs. This study will also measure a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life.