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
Launched by AMGEN · Feb 8, 2024
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment approach for patients with metastatic colorectal cancer that has a specific genetic change known as the KRAS p.G12C mutation. Researchers want to see if combining three medications—sotorasib, panitumumab, and FOLFIRI—works better than the standard treatment of FOLFIRI alone or with another drug called bevacizumab. The main goal is to find out if this new combination can help patients live longer without their cancer getting worse.
To participate in this trial, you must have a confirmed diagnosis of metastatic colorectal cancer with the KRAS p.G12C mutation. Other requirements include having measurable cancer that meets specific criteria and being in fairly good overall health. If you join, you will receive either the new treatment combination or the standard treatment for comparison. This study is currently looking for participants, and it welcomes individuals aged 65 and older, regardless of gender. It's an important step in exploring better options for patients facing this challenging condition.
Gender
ALL
Eligibility criteria
- 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
About Amgen
Amgen is a leading global biotechnology company dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. With a strong focus on areas such as oncology, cardiovascular disease, and inflammation, Amgen leverages advanced science and technology to address complex medical needs. The company is committed to improving patient outcomes through rigorous clinical trials and robust research initiatives, ensuring the highest standards of safety and efficacy in its products. With a rich pipeline of cutting-edge therapies, Amgen continues to be at the forefront of biopharmaceutical advancements, making a significant impact on healthcare worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nice, , France
Copenhagen, , Denmark
Bangkok, , Thailand
Madrid, , Spain
Madrid, , Spain
Paris, , France
Detroit, Michigan, United States
Sapporo, Hokkaido, Japan
Atlanta, Georgia, United States
Philadelphia, Pennsylvania, United States
Enschede, , Netherlands
Woodville South, South Australia, Australia
Toowoomba, Queensland, Australia
Essen, , Germany
Bedford Park, South Australia, Australia
Norwalk, Connecticut, United States
Maidstone, , United Kingdom
Odense C, , Denmark
Santander, Cantabria, Spain
Granada, , Spain
Gent, , Belgium
Chuo Ku, Tokyo, Japan
Seoul, , Korea, Republic Of
Cordoba, , Spain
Taichung, , Taiwan
Taichung, , Taiwan
Sevilla, , Spain
Creteil, , France
Seoul, , Korea, Republic Of
Athens, , Greece
Athens, , Greece
Seoul, , Korea, Republic Of
Izmir, , Turkey
Seoul, , Korea, Republic Of
Wolfsburg, , Germany
Brno, , Czechia
Rock Hill, South Carolina, United States
Niigata Shi, Niigata, Japan
Sunto Gun, Shizuoka, Japan
Monterrey, , Mexico
Buenos Aires, , Argentina
Praha 10, , Czechia
Barcelona, , Spain
Ploiesti, , Romania
Bucharest, , Romania
Cordoba, , Argentina
Dresden, , Germany
Budapest, , Hungary
Lyon, , France
Praha 5, , Czechia
Northwood, , United Kingdom
Graz, , Austria
Ulm, , Germany
Tallinn, , Estonia
Hradec Kralove, , Czechia
Santiago, , Chile
Pikeville, Kentucky, United States
Aarhus N, , Denmark
Grand Rapids, Michigan, United States
Pisa, , Italy
Chemnitz, , Germany
Brescia, , Italy
Elche, Comunidad Valenciana, Spain
Taipei, , Taiwan
Aalborg, , Denmark
Paris Cedex 10, , France
Milano, , Italy
Larissa, , Greece
Jacksonville, Florida, United States
Skokie, Illinois, United States
Firenze, , Italy
Nashville, Tennessee, United States
Maastricht, , Netherlands
London, , United Kingdom
Zuerich, , Switzerland
Kowloon, , Hong Kong
Burgos, , Spain
Seoul, , Korea, Republic Of
Yokohama Shi, Kanagawa, Japan
Iasi, , Romania
Malaga, , Spain
Camperdown, New South Wales, Australia
Suita Shi, Osaka, Japan
Debrecen, , Hungary
Durham, North Carolina, United States
Monterrey, Nuevo León, Mexico
Hong Kong, , Hong Kong
Madrid, , Spain
Coimbra, , Portugal
Poitiers Cedex, , France
Oviedo, Asturias, Spain
Piraeus, , Greece
Montpellier Cedex 5, , France
Fukuoka Shi, Fukuoka, Japan
Olomouc, , Czechia
Heidelberg, Victoria, Australia
Paris Cedex 13, , France
Wien, , Austria
Thessaloniki, , Greece
Valencia, Comunidad Valenciana, Spain
Itajai, Santa Catarina, Brazil
Chiba Shi, Chiba, Japan
Tokushima Shi, Tokushima, Japan
Matsuyama Shi, Ehime, Japan
Cluj Napoca, , Romania
Plovdiv, , Bulgaria
Pamplona, Navarra, Spain
Kashiwa Shi, Chiba, Japan
Koto Ku, Tokyo, Japan
Bruxelles, , Belgium
Barcelona, Cataluña, Spain
Seoul, , Korea, Republic Of
Lisboa, , Portugal
Valencia, Comunidad Valenciana, Spain
Los Angeles, California, United States
Reims, , France
Sevilla, Andalucía, Spain
Rennes Cedex 9, , France
Ourense, Galicia, Spain
Rankweil, , Austria
Brasilia, Distrito Federal, Brazil
Berlin, , Germany
Hirakata Shi, Osaka, Japan
Milano, , Italy
Sofia, , Bulgaria
Athens, , Greece
Timisoara, , Romania
Genova, , Italy
São José Do Rio Preto, , Brazil
Kitaadachi Gun, Saitama, Japan
Istanbul, , Turkey
Leuven, , Belgium
Goyang Si, Gyeonggi Do, , Korea, Republic Of
Seoul, , Korea, Republic Of
Los Alamitos, California, United States
Malatya, , Turkey
Orange City, Florida, United States
Teresina, Piauí, Brazil
Thessaloniki, , Greece
Matosinhos, , Portugal
Ankara, , Turkey
Edirne, , Turkey
La Rioja, , Argentina
Haskovo, , Bulgaria
Barcelona, Cataluña, Spain
Brussels, , Belgium
Roeselare, , Belgium
São José Do Rio Preto, São Paulo, Brazil
Nagoya Shi, Aichi, Japan
Kawasaki Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Goyang Si Gyeonggi Do, , Korea, Republic Of
Foggia, , Italy
Porto Alegre, Rio Grande Do Sul, Brazil
Valdivia, , Chile
Taoyuan, , Taiwan
Istanbul, , Turkey
Linz, , Austria
Cordoba, Andalucía, Spain
Barcelona, , Spain
Sofia, , Bulgaria
Temuco, Cautín, Chile
Lisboa, , Portugal
Akashi Shi, Hyogo, Japan
Athens, , Greece
Birmingham, , United Kingdom
Praha 8, , Czechia
Amsterdam, , Netherlands
Viedma, Río Negro, Argentina
Burgos, Castilla León, Spain
Lisboa, , Portugal
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Natal, Rio Grande Do Norte, Brazil
Providencia, Santiago, Chile
Granada, Andalucía, Spain
San Miguel De Tucuman, Tucuman, Argentina
Ijui, Rio Grande Do Sul, Brazil
Verona, , Italy
Poznan, , Poland
Bucuresti, , Romania
Malaga, Andalucía, Spain
Osaka Shi, Osaka, Japan
Mechelen, , Belgium
Palermo, , Italy
São Paulo, , Brazil
Mexico City, Distrito Federal, Mexico
Thessaloniki, , Greece
Barretos, São Paulo, Brazil
Temuco, , Chile
Viedma, , Argentina
Castellana Grotte, , Italy
Ankara, , Turkey
Rio De Janeiro, , Brazil
Kaposvar, , Hungary
Hinsdale, Illinois, United States
Plovdiv, , Bulgaria
Nyiregyhaza, , Hungary
Gyula, , Hungary
Ankara, , Turkey
Ludwigsburg, , Germany
Craiova, , Romania
Muenchen, , Germany
Pinehurst, North Carolina, United States
Ankara, , Turkey
Cachoeiro De Itapemirim, , Brazil
Thessaloniki, , Greece
Sao Paulo, São Paulo, Brazil
Istanbul, , Turkey
Fullerton, California, United States
Sint Niklaas, , Belgium
Floridablanca, Santander, Colombia
Santiago, , Chile
Adana, , Turkey
São Paulo, , Brazil
Szolnok, , Hungary
Rionegro, Antioquia, Colombia
Udine, , Italy
Lisboa, , Portugal
Coimbra, , Portugal
Santa Maria Da Feira, , Portugal
Almada, , Portugal
Kielce, , Poland
Margate, Florida, United States
Jacksonville, Florida, United States
Saint Priest En Jarez, , France
Bogotá, Cundinamarca, Colombia
Hong Kong, , Hong Kong
Kanagawa, Yokohama, Japan
Taichung City, Xitun District, Taiwan
Plantation, Florida, United States
Bridgeton, Missouri, United States
Mickleton, New Jersey, United States
Caba, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Cordoba, Córdoba, Argentina
Konya, , Turkey
Chandler, Arizona, United States
La Plata, Buenos Aires, Argentina
San Miguel De Tucuman, Tucuman, Argentina
Cordoba, Córdoba, Argentina
Mar Del Plata, Buenos Aires, Argentina
Cachoeiro De Itapemirim, Espírito Santo, Brazil
Sao Paulo, São Paulo, Brazil
Bogota, Cundinamarca, Colombia
Barretos, São Paulo, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Montería, Córdoba, Colombia
Las Condes, Santiago, Chile
Frankfurt Am Main, , Germany
Hamburg, , Germany
Caba, Buenos Aires, Argentina
Vitacura, Santiago, Chile
Montería, Córdoba, Colombia
Benito Juárez, Distrito Federal, Mexico
Stockholm, , Sweden
Clermont Ferrand Cedex 1, , France
Dijon Cedex, , France
Suita Shi, Osaka, Japan
Santiago, , Chile
Vandoeuvre Les Nancy Cedex, , France
Cordoba, Córdoba, Argentina
Charleroi, , Belgium
Pessac, , France
Saint Herblain Cedex, , France
Temuco, Cautín, Chile
Santiago, , Chile
Nashville, Tennessee, United States
Cordoba, , Argentina
Warszawa, , Poland
Pesaro, , Italy
Barretos, , Brazil
Teresina, , Brazil
Badalona, , Spain
Sao Paulo, , Brazil
Cordoba, , Argentina
Barretos, , Brazil
Sao Paulo, , Brazil
Temuco, , Chile
Montería, , Colombia
Medellin, Antioquia, Colombia
Opole, , Poland
Stockholm, , Sweden
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported