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

Protocol # :
Non Small Cell Lung Cancer
KRAS Activating Mutation
Disease Sites
Principal Investigator
Janne, Pasi, A
Site Research Nurses
Becker, Simone
Janell, Samantha
Kelley, Elaine
Lam, Ethan
Sullivan, Molly, O'Brien

Trial Description

This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy or
VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.

Eligibility Requirements

Inclusion Criteria:

- Male or female subjects ≥ 18 years of age

- Histologic or cytologic evidence of NSCLC

- Known KRAS or BRAF mutation

- The subject must have received appropriate prior therapy

- Measurable disease according to RECIST 1.1

- An Eastern Cooperative Group (ECOG) performance status ≤ 1

- Adequate organ function

- Adequate recovery from toxicities related to prior treatments

- Agreement to use highly effective method of contraceptive

Exclusion Criteria:

- Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy

- History of prior malignancy, with the exception of curatively treated malignancies

- Major surgery within 4 weeks (excluding placement of vascular access)

- History of treatment with a direct and specific inhibitor of MEK, KRAS or BRAF except
for treatment of BRAF V-600E mutant NSCLC

- Exposure to strong CYP2C9 and CYP3A4 inhibitors or inducers within 7 days prior to the
first dose and during the course of therapy

- Symptomatic brain metastases requiring steroids or other local interventions.

- Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy

- Active skin disorder that has required systemic therapy within the past 1 year

- History of rhabdomyolysis

- Concurrent ocular disorders

- Concurrent heart disease or severe obstructive pulmonary disease

- Subjects with the inability to swallow oral medications