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 · NCT06252649 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 14 US states.
- Ironwood Cancer and Research Centers Scottsdale - Chandler, Arizona, United States
- Providence Saint Jude Medical Center - Fullerton, California, United States
- City of Hope National Medical Center - Long Beach, California, United States
- Cancer and Blood Research Center, LLC - Los Alamitos, California, United States
- California Research Institute - Los Angeles, California, United States
- Norwalk Hospital - Norwalk, Connecticut, United States
- Cancer Specialists of North Florida - Southpoint - Jacksonville, Florida, United States
- D and H Cancer Research Center - Margate, Florida, United States
- Mid Florida Hematology and Oncology Centers PA - Orange City, Florida, United States
- Boca Raton Clinical Research Medical Center Inc - Plantation, Florida, United States
- Georgia Cancer Specialists - Atlanta, Georgia, United States
- Insight Research Institute - Chicago, Illinois, United States
- Hope and Healing Cancer Services - Hinsdale, Illinois, United States
- Orchard Healthcare Research Inc - Skokie, Illinois, United States
- Pikeville Medical Center - Pikeville, Kentucky, United States
- Henry Ford Health System - Detroit, Michigan, United States
- Cancer and Hematology Centers of Western Michigan - Grand Rapids, Michigan, United States
- Saint Louis Cancer Care West County - Bridgeton, Missouri, United States
- Minniti Center for Medical Oncology and Hematology - Mickleton, New Jersey, United States
- Duke Cancer Center - Durham, North Carolina, United States
- FirstHealth Cancer Center - Pinehurst, North Carolina, United States
- Thomas Jefferson University - Philadelphia, Pennsylvania, United States
- Carolina Blood and Cancer Care - Rock Hill, South Carolina, United States
- Tennessee Oncology PLLC - Chattanooga - Nashville, Tennessee, United States
- Tennessee Oncology, PLLC - Nashville, Tennessee, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Aalborg Sygehus - Aalborg, Denmark
- Aarhus University Hospital - Aarhus N, Denmark
- Adana Sehir Egitim ve Arastirma Hastanesi - Adana, Turkey (Türkiye)
- Unidade Local de Saude de Almada-Seixal, EPE - Hospital Garcia de Orta - Almada, Portugal
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek - Amsterdam, Netherlands
- Hacettepe Universitesi Tip Fakultesi Hastanesi - Ankara, Turkey (Türkiye)
- Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi - Ankara, Turkey (Türkiye)
- Ankara Universitesi Tip Fakultesi Hastanesi - Ankara, Turkey (Türkiye)
- Ankara Bilkent Sehir Hastanesi - Ankara, Turkey (Türkiye)
- General Hospital Evangelismos - Athens, Greece
- Agios Savvas Anticancer Hospital - Athens, Greece
- Athens Medical Center S.A - Psychikon - Athens, Greece
- Aretaieio Hospital - Athens, Greece
- Hygeia Hospital - Athens, Greece
- Metropolitan Hospital - Athens, Greece
- Siriraj Hospital - Bangkok, Thailand
- Charite - Universitaetsmedizin Berlin, Campus Virchow - Berlin, Germany
- Queen Elizabeth Hospital Birmingham - Birmingham, United Kingdom
- Istituto Ospedaliero Fondazione Poliambulanza - Brescia, Italy
- Masarykuv onkologicky ustav - Brno, Czechia
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc - Brussels, Belgium
- Institut Jules Bordet - Brussels, Belgium
- Institutul Clinic Fundeni - Bucharest, Romania
- Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti - Bucharest, Romania
- Semmelweis Egyetem - Budapest, Hungary
- Orszagos Onkologiai Intezet - Budapest, Hungary
- Hospital Britanico de Buenos Aires - Buenos Aires, Argentina
- Ente Ospedaliero IRCCS Saverio De Bellis - Castellana Grotte, Italy
- Grand Hôpital de Charleroi - Site des Viviers - Charleroi, Belgium
- Klinikum Chemnitz gGmbH - Chemnitz, Germany
- Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing - Clermont-Ferrand, France
- Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca - Cluj-Napoca, Romania
- Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE - Coimbra, Portugal
- Unidade Local de Saude de Coimbra, EPE - Coimbra, Portugal
Showing 60 of 291 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →