Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation
Recruiting now · Phase 3
Conditions studied: Metastatic Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT06252649
- Run by
- Amgen
- People needed
- 450
- Starts
- 2024-07-17
- Expected to finish
- 2032-04-25
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Sanatorio Allende — Córdoba, Córdoba Province, Argentina (enrolling)
- Exelsus Oncologia Clinica — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
- Instituto Argentino de Diagnóstico y Tratamiento — CABA, Buenos Aires, Argentina (enrolling)
- Hospital Italiano de Córdoba — Córdoba, Córdoba Province, Argentina (enrolling)
- Clinica Universitaria Privada Reina Fabiola — Córdoba, Córdoba Province, Argentina (enrolling)
- Clinica Viedma — Viedma, Río Negro Province, Argentina (enrolling)
- Cancer and Blood Research Center, LLC — Los Alamitos, California, United States (enrolling)
- Hospital Universitario Fundacion Favaloro — CABA, Buenos Aires, Argentina (enrolling)
- Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL — CABA, Buenos Aires, Argentina (enrolling)
- Instituto de Investigaciones clinicas de Mar del Plata — Mar del Plata, Buenos Aires, Argentina (enrolling)
- Insight Research Institute — Chicago, Illinois, United States (enrolling)
- City of Hope National Medical Center — Long Beach, California, United States (enrolling)
- Cancer Specialists of North Florida - Southpoint — Jacksonville, Florida, United States (enrolling)
- Pikeville Medical Center — Pikeville, Kentucky, United States (enrolling)
- Henry Ford Health System — Detroit, Michigan, United States (enrolling)
- Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States (enrolling)
- Ironwood Cancer and Research Centers Scottsdale — Chandler, Arizona, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- Duke Cancer Center — Durham, North Carolina, United States (enrolling)
- California Research Institute — Los Angeles, California, United States (enrolling)
- Cemic — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
- Sanatorio Británico de Rosario — La Plata, Buenos Aires, Argentina (enrolling)
- Tennessee Oncology PLLC - Chattanooga — Nashville, Tennessee, United States (enrolling)
- Tennessee Oncology, PLLC — Nashville, Tennessee, United States (enrolling)
- Hospital Britanico de Buenos Aires — Buenos Aires, Argentina (enrolling)
Full record on ClinicalTrials.gov
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