The purpose of the RAMP 202 study, also referred to as a trial, is to see whether an investigational drug called VS-6766 given to patients with progressive or active NSCLC with a KRAS or BRAF mutation works better alone or when given in combination with a second investigational drug, defactinib. The trial will measure effectiveness, including overall response rate, and safety. The study is being conducted by cancer specialists.
If you are eligible and agree to participate in this study, you will be treated with either VS-6766 alone or a combination of VS-6766 with defactinib, for up to one year with follow up appointments. This is an open-label trial. Every patient will be treated with an active oral study drug, and their investigator will not be comparing it to a placebo.
VS-6766 and defactinib are investigational compounds that have not been approved by the U.S. Food and Drug Administration (FDA). Defactinib was granted Orphan Drug Designation in ovarian cancer and mesothelioma in the U.S., EU and Australia.
RAMP 202 study also includes BRAF-mutant NSCLC. In Part A of the study, the Company expects to enroll two cohorts comprised of 15 patients each to evaluate the combination in patients with V600E or non V600E BRAF mutations.
Trial is enrolling for BRAF cohort only.