Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT05198934
Phase
PHASE3
Status
Completed

Conditions

  • Colorectal Cancer (CRC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Sotorasib — DRUG
    Sotorasib will be administered orally
  • Panitumumab — DRUG
    Panitumumab will be administered as intravenous (IV) infusion
  • Trifluridine and Tipiracil — DRUG
    Trifluridine and Tipiracil will be administered orally
  • Regorafenib — DRUG
    Regorafenib will be administered orally

Study Details

The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib).

Key Dates

Start date
Apr 19, 2022
Status verified
Apr 2026
Primary completion
Jul 16, 2025
Completion
Apr 14, 2026

Study Design

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

Arms

  • Experimental: Arm A: Sotorasib 960 mg QD + panitumumab
  • Experimental: Arm B: Sotorasib 240 mg QD + panitumumab
  • Active Comparator: Arm C : Investigator's choice
    Participants will be administered trifluridine and tipiracil, or regorafenib

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Approximately 3 years ]

Locations (20)

FacilityCityStateZIPSite coordinators
Central Alabama ResearchBirminghamAlabama35209-
City of Hope National Medical CenterDuarteCalifornia91010-
University of California IrvineOrangeCalifornia92868-
Johns Hopkins University School of MedicineWashington D.C.District of Columbia20016-
Cancer Specialists of North FloridaJacksonvilleFlorida32256-
Lakes Research LLCMiami LakesFlorida33014-
Northwest Georgia Oncology Centers PCMariettaGeorgia30060-
University of MichiganAnn ArborMichigan48106-0995-
Revive Research InstituteFarmington HillsMichigan48334-
Sparrow Clinical Research InstituteLansingMichigan48912-
Revive Research InstituteSterling HeightsMichigan48314-
Upstate University HospitalSyracuseNew York13210-
White Plains Hospital Center for Cancer CareWhite PlainsNew York10601-
Moses H Cone Memorial HospitalGreensboroNorth Carolina27403-
The Mark H Zangmeister CenterColumbusOhio43210-
Lancaster General Hospital Ann B Barshinger Cancer InstituteLancasterPennsylvania17601-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Best Cancer Care & HematologyHoustonTexas77089-
Kelsey Research FoundationHoustonTexas77025-
Lumi ResearchKingwoodTexas77339-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By research site
Central Alabama Research· Birmingham, ALCity of Hope National Medical Center· Duarte, CAUniversity of California Irvine· Orange, CAJohns Hopkins University School of Medicine· Washington D.C., DCCancer Specialists of North Florida· Jacksonville, FLLakes Research LLC· Miami Lakes, FL

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