This is a clinical study for adults with Non-Small Cell Lung Cancer (NSCLC) that has spread outside the lungs, and has a mutation (change) in the BRAF gene. This mutation – which is called BRAFV600E or BRAFV600K or BRAFV600D – can cause abnormal, uncontrolled growth in the tumor.
The purpose of this research study is to determine how safe and effective encorafenib is when given in combination with binimetinib in subjects with metastatic non-small cell lung cancer (NSCLC) who have been found by their doctor to have a gene called BRAFV600E that has mutated. Encorafenib and binimetinib combination treatment has been tested previously in approximately 921 subjects with metastatic BRAFV600E-mutant melanoma.
The standard dose of encorafenib 450 mg orally (by mouth) once a day in combination with binimetinib 45 mg orally (by mouth) twice a day has been approved by the United States Food and Drug Administration (FDA) and in the European Union (EU) for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E mutation as detected by an FDA-approved test, but not for the treatment of NSCLC. Therefore, both these medicines are considered investigational as used in this study.
All study participants will receive the same dose of the study drugs, encorafenib and binimetinib. Encorafenib (450 mg (6 capsules x 75 mg)) are capsules that are taken by mouth, once a day, in the morning. Binimetinib (45 mg (3 capsules x 15 mg)) are tablets that are taken by mouth, twice a day, in the morning and in the evening. No placebo treatments are used in this study.
Study participants will be in the study for approximately 24 months. Following the end of the study, participants may be followed for up to 5 years.