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Keep this study
Lead
Verastem, Inc.
This is a multicenter, open-label Phase 2 study designed to evaluate safety and tolerability and efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with KRAS and BRAF mutant NSCLC following treatment with an appropriate platinum-based regimen and an approved immune checkpoint inhibitor (CPI).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer
