Recruiting
Phase 3

Sotorasib & Panitumumab & FOLFIRI

Sponsor:

Amgen

Code:

NCT06252649

Conditions

Metastatic Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FOLFIRI Regimen

Sotorasib

Panitumumab

Bevacizumab-awwb

Study Details

Brief summary:

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.

Conditions

Metastatic Colorectal Cancer

Study ID

NCT06252649

Start date

Jul 17, 2024

Status verified date

Sep, 2026

Completion date

Apr 25, 2032

Anticipated

Primary completion date

Sep 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Arm B: FOLFIRI with or Without Bevacizumab-awwb

Participants will receive FOLFIRI Q2W with or without bevacizumab-awwb.

Interventions

FOLFIRI Regimen

Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.

Sotorasib

Immediate-release solid dosage form administered orally.

Panitumumab

Administered via IV infusion Q2W.

Bevacizumab-awwb

Administered via IV infusion Q2W.

Primary outcome measure

  • PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: Up to Approximately 3 Years ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Ironwood Cancer and Research Centers Scottsdale

Recruiting

Chandler, Arizona, United States, 85224

City of Hope National Medical Center

Recruiting

Long Beach, California, United States, 90813

Cancer and Blood Research Center, LLC

Recruiting

Los Alamitos, California, United States, 90720

Cancer Specialists of North Florida - Southpoint

Recruiting

Jacksonville, Florida, United States, 32256

Insight Research Institute

Recruiting

Chicago, Illinois, United States, 60616

Pikeville Medical Center

Recruiting

Pikeville, Kentucky, United States, 41501

Cancer and Hematology Centers of Western Michigan

Recruiting

Grand Rapids, Michigan, United States, 49503

Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Tennessee Oncology PLLC - Chattanooga

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC

Recruiting

Nashville, Tennessee, United States, 37203

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Arthur J E Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

William Osler Health System - Brampton Civic Hospital

Recruiting

Brampton, Ontario, Canada, L6R 3J7

Sunnybrook Research Institute Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Allan Blair Cancer Centre

Recruiting

Regina, Saskatchewan, Canada, S4T 7T1

Saskatoon Cancer Centre

Recruiting

Saskatoon, Saskatchewan, Canada, S7N 4H4

More Information

Sponsor

Amgen

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Sotorasib
  • Panitumumab
  • FOLFIRI
  • Bevacizumab-awwb
  • Oncology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Amgen on 2026-09-03.