Clinical Trial for BRAF Mutant Non-Small Cell Lung Cancer (NSCLC) Now Enrolling BRAF Cohort

Phase 2 clinical trial which includes KRAS and BRAF mutations, with BRAF open and enrolling.

Trial Overview

Study Overview:
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.

Protocol Title:
A Phase 2 Study pf VS-6766 (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination With Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) and BRAF-Mutant (BRAF-MT) Non-Small Cell Lung Cancer (NSCLC) (RAMP 202)

Protocol Numbers:
VS-6766-202 (Verastem, Inc.)
Clinical Trial NCT04620330

Study Drugs or Compounds: VS-6766 and Defactinib (VS-6063)
Study Phase: Phase 2
Total Enrollment: Estimated at 100 patients

Study Short Title:
A Phase 2 Study of VS-6766 Alone and In Combination with Defactinib in Non-Small Cell Lung Cancer (NSCLC)

Sponsor:
Verastem Oncology

People who participate in this trial must meet the following requirements:

You are age 18 or older.
You have recurrent NSCLC.
You have recurrent NSCLC with a tumor gene that makes a protein called KRAS, also called a KRAS gene mutation (KRAS+).
You have previously been treated with at least one prior systemic regimen such as platinum-based chemotherapy, monoclonal antibody, EGFR, or ALK.
You cannot have previously been treated with a direct and specific inhibitor of MEK or KRAS.
You are willing to participate in a clinical trial.

Patients who enroll in the RAMP 202 trial:

Will attend study visits every two weeks.
Will take the study drug at home as an oral formulation.
Will not be charged to participate.
May withdraw from the trial at any time.

To see if you may be eligible, click below

Are you Eligible?