A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT06497556
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Divarasib — DRUG
    Divarasib will be administered orally QD
  • Sotorasib — DRUG
    Sotorasib will be administered orally QD
  • Adagrasib — DRUG
    Adagrasib will be administred orally BID

Study Details

The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).

Key Dates

Start date
Sep 23, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Nov 30, 2029

Study Design

Enrollment
338 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Divarasib
    Participants will receive divarasib orally, once daily (QD).
  • Active Comparator: KRAS G12C inhibitor
    Participants will receive sotorasib orally QD or adagrasib orally twice a day (BID)

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 4 years ]

Locations (25)

FacilityCityStateZIPSite coordinators
Banner Health MD Anderson AZGilbertArizona85234-
Los Angeles Cancer NetworkLos AngelesCalifornia90017-4803-
UCLA Hematology / Oncology ClinicLos AngelesCalifornia90095-
University of California, San FranciscoSan FranciscoCalifornia94158-
Yale Cancer CenterNew HavenConnecticut06519-
University of MiamiMiamiFlorida33136-
Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg)St. PetersburgFlorida33701-4553-
University of Chicago Medical CenterChicagoIllinois60637-
New England Cancer SpecialistsWestbrookMaine04092-
Dana Farber Cancer InstituteBostonMassachusetts02215-
University of MichiganAnn ArborMichigan48109-0934-
Cancer and Hematology Centers of Western MichiganGrand RapidsMichigan49503-
Minnesota Oncology EdinaEdinaMinnesota55435-
Columbia University Medical CenterNew YorkNew York10032-
Taylor Cancer Research CenterMaumeeOhio43537-
Oncology Associates of Oregon, P.CEugeneOregon97401-
Oregon Health & Science UniversityPortlandOregon97239-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Allegheny Cancer CenterPittsburghPennsylvania15212-
Tennessee Oncology, PLLC - ChattanoogaChattanoogaTennessee37404-
Baptist Clinical Research InstituteMemphisTennessee38120-
Tennessee OncologyNashvilleTennessee37203-
JPS Health NetworkFort WorthTexas76104-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology - Northeast TexasLongviewTexas75601-

Find similar trials in Gilbert, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Banner Health MD Anderson AZ· Gilbert, AZLos Angeles Cancer Network· Los Angeles, CAUCLA Hematology / Oncology Clinic· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAYale Cancer Center· New Haven, CTUniversity of Miami· Miami, FL

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