Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
Revolution Medicines, Inc.
Study ID
NCT05054725
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • RMC-4630 — DRUG
    RMC-4630 administered orally as a capsule
  • Sotorasib — DRUG
    Sotorasib administered orally as a tablet

Study Details

The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC

Key Dates

Start date
Dec 30, 2021
Status verified
Dec 2025
Primary completion
Jul 3, 2024
Completion
Aug 29, 2024

Study Design

Enrollment
47 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: RMC-4630 and sotorasib, Safety Run-in
    Safety Run-In: RMC-4630 and sotorasib
  • Experimental: RMC-4630 and sotorasib, Expansion
    Dose Expansion: RMC-4630 and sotorasib

Primary Outcome Measure

Objective Response Rate (ORR) as Assessed Per RECIST v1.1 [ Time Frame: 31 months ]

Locations (23)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33901-
BRCR Medical Center Inc.PlantationFlorida33322-
Cancer Specialists of North FloridaSaint AugustineFlorida32086-
GenHarp Clinical SolutionsEvergreen ParkIllinois60805-
Hematology Oncology ClinicBaton RougeLouisiana70809-
New England Cancer SpecialistsScarboroughMaine04074-
American Oncology Partners of Maryland, PABethesdaMaryland20817-
Maryland Oncology Hematology, P.A.ColumbiaMaryland21044-
Minnesota Oncology Hematology, P.A.MinneapolisMinnesota55404-
Nebraska Cancer SpecialistsOmahaNebraska68130-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
New Jersey Center for Cancer ResearchBrickNew Jersey08724-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87131-
Roswell Park cancer InstituteBuffaloNew York14263-
Clinical Research Alliance, Inc.New YorkNew York10021-
Zangmeister Cancer CenterColumbusOhio43219-
Charleston OncologyCharlestonSouth Carolina29414-
Tennessee OncologyChattanoogaTennessee37404-
Sarah Cannon Research InstituteNashvilleTennessee37203-
CHRISTUS St. Michael-Colom and Carney Clinic P.ATexarkanaTexas75503-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Virginia Oncology AssociatesNorfolkVirginia23502-
Northwest Cancer specialists, P.C.VancouverWashington98684-

Related coverage on Hipa.ai

Find similar trials in Fort Myers, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Florida Cancer Specialists· Fort Myers, FLBRCR Medical Center Inc.· Plantation, FLCancer Specialists of North Florida· Saint Augustine, FLGenHarp Clinical Solutions· Evergreen Park, ILHematology Oncology Clinic· Baton Rouge, LANew England Cancer Specialists· Scarborough, ME

Related Studies