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Purpose

The aim of this study is to compare progression free survival (PFS) in treatment-naïve Participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay. - Central confirmation of KRAS p.G12C mutation - Measurable metastatic disease per RECIST v1.1 criteria. - Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1. - Adequate organ function.

Exclusion Criteria

  • Active, untreated brain metastases. - Leptomeningeal disease - Previous treatment with a KRAS p.G12C inhibitor - History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Sotorasib + Panitumumab + FOLFIRI 		Sotorasib was taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI were received every 2 weeks (Q2W) via intravenous infusion (IV).
  • Drug: FOLFIRI Regimen
    Combination of irinotecan, leucovorin, and 5-fluorouracil given intravenously Q2W.
  • Drug: Sotorasib
    Immediate-release solid dosage form administered PO.
    Other names:
    • AMG 510
    • Lumakras
    • Lumykras
  • Drug: Panitumumab
    Administered IV Q2W.
    Other names:
    • Vectibix
Active Comparator
Arm B: FOLFIRI with or Without Bevacizumab-awwb 		Participants received FOLFIRI Q2W with or without bevacizumab-awwb.
  • Drug: FOLFIRI Regimen
    Combination of irinotecan, leucovorin, and 5-fluorouracil given intravenously Q2W.
  • Drug: Bevacizumab-awwb
    Administered IV Q2W.
    Other names:
    • MVASI

Recruiting Locations

Ironwood Cancer and Research Centers Scottsdale
Chandler, Arizona 85224

Providence Saint Jude Medical Center
Fullerton, California 92835

Cancer and Blood Specialty Clinic
Los Alamitos, California 90720

California Research Institute
Los Angeles, California 90027

Norwalk Hospital
Norwalk, Connecticut 06856

Cancer Specialists of North Florida
Jacksonville, Florida 32256

D and H Cancer Research Center
Margate, Florida 33063

Mid Florida Hematology and Oncology Centers PA
Orange City, Florida 32763

Boca Raton Clinical Research Medical Center Inc
Plantation, Florida 33322

Georgia Cancer Specialists
Atlanta, Georgia 30342

Hope and Healing Cancer Services
Hinsdale, Illinois 60521

Orchard Healthcare Research Inc
Skokie, Illinois 60076

Pikeville Medical Center
Pikeville, Kentucky 41501

Henry Ford Health System
Detroit, Michigan 48202

Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan 49503

Saint Louis Cancer Care West County
Bridgeton, Missouri 63044

Minniti Center for Medical Oncology and Hematology
Mickleton, New Jersey 08056

Duke Cancer Center
Durham, North Carolina 27710

FirstHealth Cancer Center
Pinehurst, North Carolina 28374

Thomas Jefferson University
Philadelphia, Pennsylvania 19107

Tennessee Oncology PLLC - Chattanooga
Nashville, Tennessee 37203

Tennessee Oncology PLLC
Nashville, Tennessee 37203

More Details

NCT ID
NCT06252649
Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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