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

Part of paid clinical trials in Duarte, California.

Sponsor
Verastem, Inc.
Study ID
NCT04620330
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Dec 31, 2020
Status verified
Jan 2024
Primary completion
Aug 29, 2023
Completion
Dec 12, 2023

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: avutometinib (VS-6766) monotherapy
    in patients with NSCLC KRAS-G12V tumor
  • Experimental: Arm 2: avutometinib (VS-6766) in combination with defactinib
    in patients with a NSCLC KRAS-G12V tumor
  • Experimental: Arm 3: avutometinib (VS-6766) in combination with defactinib
    in patients with a NSCLC KRAS-other (non-G12V) tumor
  • Experimental: Arm 4: avutometinib (VS-6766) in combination with defactinib
    in patients with a NSCLC BRAF-V600E tumor
  • Experimental: Arm 5:avutometinib (VS-6766) in combination with defactinib
    in patients with a NSCLC BRAF-non-V600E tumor

Primary Outcome Measure

To determine the optimal regimen, either avutometinib (VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, in KRAS-G12V NSCLC [ Time Frame: From start of treatment to confirmation of response; 24 weeks ]

Locations (28)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of Colorado HospitalAuroraColorado80045-
Rocky Mountain Cancer CentersLone TreeColorado80124-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Florida Cancer SpecialistsFort MyersFlorida33908-
Florida Cancer SpecialistsSt. PetersburgFlorida33705-
Emory University School of MedicineAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
University of Chicago Medical Center-Duchossois Center for Advanced MedicineChicagoIllinois60637-
Illinois Cancer SpecialistsNilesIllinois60714-
Hematology/Oncology Clinic, LLPBaton RougeLouisiana70809-
Maryland Oncology Hematology P.AColumbiaMaryland21044-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford Cancer Institute/Henry Ford Health SystemDetroitMichigan48202-
Washington University School of MedicineSt LouisMissouri63110-
Hackensack University Medical CenterHackensackNew Jersey07601-
Northwell Health-Monter Cancer CenterLake SuccessNew York11042-
Zangmeister Cancer CenterColumbusOhio43219-
Northwest Cancer Specialists, P.C.PortlandOregon97213-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Univ. of Pittsburgh Med CenterPittsburghPennsylvania15232-
Chattanooga Oncology Hematology Assoc.ChattanoogaTennessee037404-
Tennessee OncologyNashvilleTennessee37203-
Texas OncologyDallasTexas75246-
Texas Oncology Ft Worth Cancer CenterFort WorthTexas76104-
Texas OncologyGrapevineTexas76051-
MD Anderson Cancer CenterHoustonTexas77030-
Virginia Cancer Specialists, PCFairfaxVirginia22031-

Find similar trials in Duarte, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
City of Hope· Duarte, CAUniversity of Colorado Hospital· Aurora, CORocky Mountain Cancer Centers· Lone Tree, COGeorgetown University Medical Center· Washington D.C., DCFlorida Cancer Specialists· Fort Myers, FLFlorida Cancer Specialists· St. Petersburg, FL

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