A Phase II study of the BRAF inhibitor Encorafenib in combination with the MEK inhibitor Binimetinib in Patients with BRAFV600E-mutant metastatic Non-small Cell Lung Cancer
Name: Encorafenib 75 MG
Name: Binimetinib 15 MG
Name: Docetaxel
Description: Objective Response Rate at 6 months using RECIST1.1 criteria
Measure: Objective response rate Time: 8 weeksDescription: Time from the date of the first documented response (CR or PR) to the earliest date of disease progression (RECIST 1.1), or death due to any cause.
Measure: Duration Response Rate Time: 8 weeksDescription: Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)
Measure: Progression-free Survival Time: about 24 monthsDescription: Time from enrollment until death due to any cause
Measure: Overall Survival Time: about 24 monthsDescription: Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Measure: Incidence, type and severity of adverse events Time: From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)Allocation: Randomized
Crossover Assignment
There is one SNP
Non Small Cell Lung Cancer BRAF V600E Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- V600E ---