A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer
NCT ID: NCT04620330
Last Updated: 2024-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2020-12-31
2023-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1: avutometinib (VS-6766) monotherapy
in patients with NSCLC KRAS-G12V tumor
avutometinib (VS-6766)
Monotherapy
Arm 2: avutometinib (VS-6766) in combination with defactinib
in patients with a NSCLC KRAS-G12V tumor
avutometinib (VS-6766) and Defactinib
Combination therapy
Arm 3: avutometinib (VS-6766) in combination with defactinib
in patients with a NSCLC KRAS-other (non-G12V) tumor
avutometinib (VS-6766) and Defactinib
Combination therapy
Arm 4: avutometinib (VS-6766) in combination with defactinib
in patients with a NSCLC BRAF-V600E tumor
avutometinib (VS-6766) and Defactinib
Combination therapy
Arm 5:avutometinib (VS-6766) in combination with defactinib
in patients with a NSCLC BRAF-non-V600E tumor
avutometinib (VS-6766) and Defactinib
Combination therapy
Interventions
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avutometinib (VS-6766)
Monotherapy
avutometinib (VS-6766) and Defactinib
Combination therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Verastem, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ross Camidge, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
MD Verastem
Role: STUDY_DIRECTOR
Verastem, Inc.
Locations
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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
Texas Oncology
Grapevine, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Centre Leon Berard
Lyon, , France
Hopital Nord Marseille
Marseille, , France
Hopital Cochin
Paris, , France
Institute De Cancerologie De L'Ouest Site Paul Papin Oncologie Medicale
Saint-Herblain, , France
Cancerologie Gustave Roussy - Cancer Medicine
Villejuif, , France
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Universitatsklinkum Leipzig
Leipzig, , Germany
Evangelisches Klinkum Bethel
Straße, , Germany
Azienda Ospedaliera Universitaria
Orbassano, Torino, Italy
Irccs, Irts
Meldola, , Italy
UOC di Oncologia Medica
Parma, , Italy
Centro Ricerche Cliniche di Verona
Verona, , Italy
Complejo Hospitalario Universiario a Coruna Teresa
A Coruña, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital 12 de Octubre
Córdoba, , Spain
Universitario de Teatinos
Málaga, , Spain
Hospital Universitario Virgen de la Macarena
Seville, , Spain
Countries
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References
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Capelletto E, Bironzo P, Denis L, Koustenis A, Bungaro M, Novello S. Single agent VS-6766 or VS-6766 plus defactinib in KRAS-mutant non-small-cell lung cancer: the RAMP-202 phase II trial. Future Oncol. 2022 May;18(16):1907-1915. doi: 10.2217/fon-2021-1582. Epub 2022 Mar 14.
Other Identifiers
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VS-6766-202
Identifier Type: -
Identifier Source: org_study_id
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