A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Non Small Cell Lung Cancer, KRAS Activating Mutation

In brief

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.

Key facts

Study ID

NCT04620330

Run by

Verastem, Inc.

People needed

90

Starts

2020-12-31

Expected to finish

2023-12-12

Last updated by the study team

2024-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• City of Hope — Duarte, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers — Lone Tree, Colorado, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists — St. Petersburg, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago Medical Center-Duchossois Center for Advanced Medicine — Chicago, Illinois, United States
• Illinois Cancer Specialists — Niles, Illinois, United States
• Hematology/Oncology Clinic, LLP — Baton Rouge, Louisiana, United States
• Maryland Oncology Hematology P.A — Columbia, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Henry Ford Cancer Institute/Henry Ford Health System — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Northwell Health-Monter Cancer Center — Lake Success, New York, United States
• Zangmeister Cancer Center — Columbus, Ohio, United States
• Northwest Cancer Specialists, P.C. — Portland, Oregon, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Univ. of Pittsburgh Med Center — Pittsburgh, Pennsylvania, United States
• Chattanooga Oncology Hematology Assoc. — Chattanooga, Tennessee, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Texas Oncology — Dallas, Texas, United States
• Texas Oncology Ft Worth Cancer Center — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.