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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 12, 2024 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.