Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Verastem, Inc.
With
Amgen
This is a multicenter, non-randomized, open-label Phase 1/2 study designed to evaluate safety and tolerability and efficacy of avutometinib (VS-6766) in combination with sotorasib with or without defactinib in patients with KRAS G12C mutant NSCLC.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients ≥ 18 years of age
Histologic or cytologic evidence of NSCLC
Known KRAS G12C mutation
Either exposed or not exposed to a KRAS inhibitor to be included in Part A (avutometinib + sotorasib + defactinib) and not exposed to KRAS inhibitor to be included in Part B (avutometinib + sotorasib + defactinib), Cohort 1
Received at least 1 dose of a G12C inhibitor to be included in Part B, Cohort 2 (avutometinib + sotorasib + defactinib)
Must have received appropriate treatment with at least one prior systemic regimen, but no more than 2 prior regimens, for Stage 3B-C or 4 NSCLC
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, minor surgery within 2 weeks (excluding placement of vascular access)
History of treatment with a direct and specific inhibitor of MEK
Exposure to strong CYP3A4 inhibitors or inducers within 14 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
Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active
Active skin disorder that has required systemic therapy within the past year
History of rhabdomyolysis
Concurrent ocular disorders
Concurrent heart disease or severe obstructive pulmonary disease
Inability to swallow oral medications
Female patients that are pregnant or breastfeeding
Previously treated with sotorasib and were dose reduced due to toxicity
