A Study of VS-6766 v. VS-6766 + Defactinib in Recurrent G12V or Other KRAS-Mutant Non-Small Cell Lung Cancer
This study will assess the safety and efficacy of VS-6766 monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.
- Non Small Cell Lung Cancer
- KRAS Activating Mutation
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Male or female subjects ≥ 18 years of age - Histologic or cytologic evidence of NSCLC - Known KRAS 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
- 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 or KRAS - 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
- Phase 2
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
|To determine the optimal regimen, either VS-6766 monotherapy or VS-6766 in combination with defactinib, for subsequent evaluation for efficacy in the expansion phase (Part B).||
|To determine the efficacy of the optimal regimen identified from Part A||
- Verastem, Inc.
Study ContactGloria Patrick
This is a multicenter, non-randomized, open-label Phase 1b/2 study designed to evaluate safety and tolerability and efficacy of VS-6766 versus VS-6766 in combination with defactinib in subjects with KRAS-MT NSCLC following treatment with an appropriate platinum-based regimen and an approved immune checkpoint inhibitor (CPI).