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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 Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay. - Central laboratory detection 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 will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
  • Drug: FOLFIRI Regimen
    Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
  • Drug: Sotorasib
    Immediate-release solid dosage form administered orally.
    Other names:
    • AMG 510
    • Lumakras
    • Lumykras
  • Drug: Panitumumab
    Administered via IV infusion Q2W.
    Other names:
    • Vectibix
Active Comparator
Arm B: FOLFIRI with or Without Bevacizumab-awwb 		Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.
  • Drug: FOLFIRI Regimen
    Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
  • Drug: Bevacizumab-awwb
    Administered via IV infusion Q2W.
    Other names:
    • MVASI

Recruiting Locations

Ironwood Cancer and Research Centers Scottsdale
Chandler, Arizona 85224

City of Hope National Medical Center
Long Beach, California 90813

Cancer and Blood Research Center, LLC
Los Alamitos, California 90720

Cancer Specialists of North Florida - Southpoint
Jacksonville, Florida 32256

Insight Research Institute
Chicago, Illinois 60616

Pikeville Medical Center
Pikeville, Kentucky 41501

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

Duke Cancer Center
Durham, North Carolina 27710

Tennessee Oncology PLLC - Chattanooga
Nashville, Tennessee 37203

Tennessee Oncology, PLLC
Nashville, Tennessee 37203

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Pan American Center for Oncology Trials LLC
Rio Piedras, Puerto Rico 00935

More Details

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.