A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated Jan 12, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Verastem, Inc.
- Interventions being studied
- Drug: avutometinib (VS-6766); Drug: avutometinib (VS-6766) and Defactinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of HopeDuarte, California
- University of Colorado HospitalAurora, Colorado
- Rocky Mountain Cancer CentersLone Tree, Colorado
- Georgetown University Medical CenterWashington D.C., District of Columbia
- Florida Cancer SpecialistsFort Myers, Florida
- Florida Cancer SpecialistsSt. Petersburg, Florida
- Emory University School of MedicineAtlanta, Georgia
- Northwestern UniversityChicago, Illinois
- University of Chicago Medical Center-Duchossois Center for Advanced MedicineChicago, Illinois
- Illinois Cancer SpecialistsNiles, Illinois
- Hematology/Oncology Clinic, LLPBaton Rouge, Louisiana
- Maryland Oncology Hematology P.AColumbia, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 12, 2024. Always confirm current availability with the study team.