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
CodeBreaK 301
Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
1 other identifier
interventional
450
32 countries
264
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2024
Longer than P75 for phase_3
264 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2024
CompletedFirst Posted
Study publicly available on registry
February 12, 2024
CompletedStudy Start
First participant enrolled
July 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 25, 2032
June 10, 2026
June 1, 2026
4.2 years
January 15, 2024
June 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Up to Approximately 3 Years
Secondary Outcomes (18)
Overall Survival (OS)
Up to Approximately 5 Years
Objective Response Rate (ORR) per RECIST v1.1
Up to Approximately 5 Years
Objective Response (OR) per RECIST v1.1
Up to Approximately 5 Years
Duration of Response (DOR) per RECIST v1.1
Up to Approximately 5 Years
Disease Control Rate (DCR) per RECIST v1.1
Up to Approximately 5 Years
- +13 more secondary outcomes
Study Arms (2)
Arm A: Sotorasib + Panitumumab + FOLFIRI
EXPERIMENTALSotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
Arm B: FOLFIRI with or Without Bevacizumab-awwb
ACTIVE COMPARATORParticipants will receive FOLFIRI Q2W with or without bevacizumab-awwb.
Interventions
Administered via IV infusion Q2W.
Immediate-release solid dosage form administered orally.
Administered via IV infusion Q2W.
Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (290)
Ironwood Cancer and Research Centers Scottsdale
Chandler, Arizona, 85224, United States
Providence Saint Jude Medical Center
Fullerton, California, 92835, United States
City of Hope National Medical Center
Long Beach, California, 90813, United States
Cancer and Blood Research Center, LLC
Los Alamitos, California, 90720, United States
California Research Institute
Los Angeles, California, 90027, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Cancer Specialists of North Florida - Southpoint
Jacksonville, Florida, 32256, United States
D and H Cancer Research Center
Margate, Florida, 33063, United States
Mid Florida Hematology and Oncology Centers PA
Orange City, Florida, 32763, United States
Boca Raton Clinical Research Medical Center Inc
Plantation, Florida, 33322, United States
Georgia Cancer Specialists
Atlanta, Georgia, 30342, United States
Insight Research Institute
Chicago, Illinois, 60616, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521, United States
Orchard Healthcare Research Inc
Skokie, Illinois, 60076, United States
Pikeville Medical Center
Pikeville, Kentucky, 41501, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503, United States
Saint Louis Cancer Care West County
Bridgeton, Missouri, 63044, United States
Minniti Center for Medical Oncology and Hematology
Mickleton, New Jersey, 08056, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Carolina Blood and Cancer Care
Rock Hill, South Carolina, 29732, United States
Tennessee Oncology PLLC - Chattanooga
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Hospital Universitario Fundacion Favaloro
CABA, Buenos Aires, C1093AAS, Argentina
Instituto Argentino de Diagnóstico y Tratamiento
CABA, Buenos Aires, C1093AAS, Argentina
Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL
CABA, Buenos Aires, C1425BGH, Argentina
Cemic
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO, Argentina
Sanatorio Británico de Rosario
La Plata, Buenos Aires, 1900, Argentina
Instituto de Investigaciones clinicas de Mar del Plata
Mar del Plata, Buenos Aires, B7600FZO, Argentina
Hospital Italiano de Córdoba
Córdoba, Córdoba Province, 5000, Argentina
Sanatorio Allende
Córdoba, Córdoba Province, X5000JHQ, Argentina
Clinica Universitaria Privada Reina Fabiola
Córdoba, Córdoba Province, X5004FHP, Argentina
Clinica Viedma
Viedma, Río Negro Province, 8500, Argentina
Exelsus Oncologia Clinica
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, C1280AEB, Argentina
Centro Oncologico Riojano Integral
La Rioja, F5300COE, Argentina
Chris OBrien Lifehouse
Camperdown, New South Wales, 2050, Australia
Toowoomba Hospital
Toowoomba, Queensland, 4350, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Austin Health, Austin Hospital
Heidelberg, Victoria, 3084, Australia
Medizinische Universitaet Graz
Graz, 8036, Austria
Ordensklinikum Linz Barmherzige Schwestern
Linz, 4010, Austria
Landeskrankenhaus Feldkirch
Rankweil, 6830, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Krankenhaus Wiener Neustadt
Wiener Neustadt, 2700, Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Institut Jules Bordet
Brussels, B-1070, Belgium
Grand Hôpital de Charleroi - Site des Viviers
Charleroi, 6060, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Algemeen Ziekenhuis Sint Maarten-Emmaus vzw
Mechelen, 2800, Belgium
AZ Delta Campus Rumbeke
Roeselare, 8800, Belgium
Vitaz campus Sint-Niklaas Moerland
Sint-Niklaas, 9100, Belgium
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, 29308-020, Brazil
Hospital Sirio Libanes Brasilia
Brasília, Federal District, 70200-730, Brazil
Vencer e Oncoclinica
Teresina, Piauí, 64049-200, Brazil
Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, 59075-740, Brazil
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560-030, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220, Brazil
Fundacao pio xII Barretos
Barretos, São Paulo, 14784-400, Brazil
Oncoclinicas Belo Horizonte
Barretos, São Paulo, 14784-400, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Fundacao Antonio Prudente AC Camargo Cancer Center
São Paulo, São Paulo, 01246-000, Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, 22250-205, Brazil
Instituto Cancer Sao Paulo Icesp
São Paulo, 01246-000, Brazil
Instituto Brasileiro de Controle do Cancer Ibcc
São Paulo, 04014-002, Brazil
Oncologia Rede D Or
São Paulo, 04501-000, Brazil
Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD
Haskovo, 6300, Bulgaria
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv, 4000, Bulgaria
Complex Oncology Center Plovdiv EOOD
Plovdiv, 4004, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, 1606, Bulgaria
Multiprofile Hospital for Active Treatment Serdikamed EOOD
Sofia, 1632, Bulgaria
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
William Osler Health System - Brampton Civic Hospital
Brampton, Ontario, L6R 3J7, Canada
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
James Lind Centro de Investigacion del Cancer
Temuco, Cautín, 4800827, Chile
Centro de investigacion y desarrollo oncolgico Spa
Temuco, Cautín, 4810218, Chile
Enroll SpA
Providencia, Santiago Metropolitan, 7500587, Chile
Clinica Redsalud Vitacura, Instituto del Cancer
Vitacura, Santiago Metropolitan, 7650018, Chile
Fundacion Arturo Lopez Perez
Santiago, 7500921, Chile
Centro de oncologia de precision Spa
Santiago, 7560907, Chile
Biocinetic servicios medicos limitada
Santiago, 8330336, Chile
Clinical Research Chile SpA
Valdivia, 5110683, Chile
Servicios de Salud Ips Suramericana Sas - Ips Sura Industriales
Medellín, Antioquia, 050030, Colombia
Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
Rionegro, Antioquia, 054040, Colombia
Instituto Nacional de Cancerologia
Bogota, Cundinamarca, 111711, Colombia
Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic
Bogotá, Cundinamarca, 110131, Colombia
Instituto Medico de Alta Tecnologia sas - Imat sas
Montería, Departamento de Córdoba, 230018, Colombia
Fundacion Oftalmologica de Santander - Foscal
Floridablanca, Santander Department, 681004, Colombia
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
Fakultni nemocnice Bulovka
Prague, 180 81, Czechia
Aalborg Sygehus
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus N, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Odense University Hospital
Odense C, 5000, Denmark
North Estonia Medical Centre Foundation
Tallinn, 13419, Estonia
Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing
Clermont-Ferrand, 63003, France
Hopital Henri Mondor
Créteil, 94000, France
Centre Hospitalier Universitaire de Dijon - Hopital du Bocage
Dijon, 21079, France
Hopital Prive Jean Mermoz
Lyon, 69008, France
Institut regional du Cancer Montpellier
Montpellier, 34298, France
Centre Antoine Lacassagne
Nice, 06189, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Hopital Saint Louis
Paris, 75475, France
Hopital Pitie-Salpetriere
Paris, 75651, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac, 33604, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Hopital Robert Debre
Reims, 51092, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033, France
Institut de Cancerologie de l Ouest Rene Gauducheau
Saint-Herblain, 44805, France
Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519, France
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin, 13353, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
Universitaetsklinikum Dresden
Dresden, 01307, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
UCT Universitaeres Zentrum fuer Tumorerkrankungen Frankfurt
Frankfurt am Main, 60488, Germany
Haematologisch Onkologische Praxis Eppendorf
Hamburg, 20246, Germany
Regional Kliniken Holding Klinikum Ludwigsburg
Ludwigsburg, 71640, Germany
Klinikum der LMU Muenchen
München, 81377, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Klinikum der Stadt Wolfsburg
Wolfsburg, 38440, Germany
General Hospital Evangelismos
Athens, 10676, Greece
Agios Savvas Anticancer Hospital
Athens, 11522, Greece
Athens Medical Center S.A - Psychikon
Athens, 11525, Greece
Aretaieio Hospital
Athens, 11528, Greece
Hygeia Hospital
Athens, 15123, Greece
Metropolitan Hospital
Athens, 18547, Greece
University Hospital of Larissa
Larissa, 41110, Greece
Metaxa Anticancer Hospital
Piraeus, 18537, Greece
Bioclinic of Thessaloniki
Thessaloniki, 546 22, Greece
Saint Luke Hospital
Thessaloniki, 55236, Greece
Saint Lukes Hospital SA
Thessaloniki, 55236, Greece
European Interbalkan Medical Center
Thessaloniki, 57001, Greece
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Princess Margaret Hospital
Kowloon, Hong Kong
Tuen Mun Hospital
New Territories, Hong Kong
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
Nyíregyháza, 4400, Hungary
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, 5000, Hungary
Istituto Ospedaliero Fondazione Poliambulanza
Brescia, 25124, Italy
Ente Ospedaliero IRCCS Saverio De Bellis
Castellana Grotte, 70013, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, 71100, Italy
Ospedale Policlinico San Martino IRCCS
Genova, 16132, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola FC, 47014, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi
Naples, 80131, Italy
Istituto Nazionale dei Tumori IRCCS Fondazione Giovanni Pascale
Naples, 80131, Italy
Istituto Oncologico Veneto IRCCS
Padova, 35128, Italy
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, 90127, Italy
Azienda Sanitaria Territoriale Pesaro Urbino - Presidio San Salvatore Muraglia
Pesaro, 61122, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Azienda Unità Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna
Ravenna, 48121, Italy
IRCCS Istituto Clinico Humanitas
Rozzano MI, 20089, Italy
Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia
Udine, 33100, Italy
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento
Verona, 37126, Italy
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Hyogo Cancer Center
Akashi-shi, Hyōgo, 673-8558, Japan
St Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191, Japan
National Hospital Organization Osaka National Hospital
Osaka, Osaka, 540-0006, Japan
The University of Osaka Hospital
Suita-shi, Osaka, 565-0871, Japan
Saitama Cancer Center
Kitaadachi-gun, Saitama, 362-0806, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
Tokushima University Hospital
Tokushima, Tokushima, 770-8503, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550, Japan
Centro Especializado en Investigacion y Tratamiento Oncologicos SC
Benito Juárez, Mexico City, 03104, Mexico
Health Pharma Professional Research SA de CV
Mexico City, Mexico City, 03100, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
Nederlands Kanker Instituut - Antoni van Leeuwenhoek
Amsterdam, 1066 CX, Netherlands
Albert Schweitzer Ziekenhuis, Locatie Dordwijk
Dordrecht, 3318 AT, Netherlands
Medisch Spectrum Twente
Enschede, 7512 KZ, Netherlands
Martini Ziekenhuis
Groningen, 9728 NT, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
Szpitale Pomorskie spolka z ograniczona odpowiedzialnoscia
Gdynia, 81-519, Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
Kielce, 25-734, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, 93-513, Poland
SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu
Opole, 45-061, Poland
Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie
Poznan, 61-866, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, 02-034, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Warsaw, 02-507, Poland
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy
Warsaw, 04-141, Poland
Unidade Local de Saude de Almada-Seixal, EPE - Hospital Garcia de Orta
Almada, 2801-951, Portugal
Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE
Coimbra, 3001-651, Portugal
Unidade Local de Saude de Coimbra, EPE
Coimbra, 3004-561, Portugal
Hospital Cuf Tejo
Lisbon, 1350-352, Portugal
Fundacao Champalimaud
Lisbon, 1400-038, Portugal
Hospital da Luz, SA
Lisbon, 1500-650, Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, 4464-513, Portugal
Unidade Local de Saude de Entre Douro e Vouga, EPE - Hospital de Sao Sebastiao
Santa Maria da Feira, 4520-211, Portugal
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
Bucharest, 022338, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015, Romania
Centrul de Oncologie Sf Nectarie SRL
Craiova, 200542, Romania
Institutul Regional de Oncologie Iasi
Iași, 700483, Romania
Spitalul Municipal Ploiesti
Ploieşti, 100337, Romania
SC Oncomed SRL
Timișoara, 300239, Romania
Vychodoslovensky onkologicky ustav, as
Košice, 041 90, Slovakia
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004, Spain
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, 18014, Spain
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29010, Spain
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013, Spain
Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario de Burgos
Burgos, Castille and León, 09006, Spain
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, 08916, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, 08908, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Galicia, 32005, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital General Universitario de Elche
Elche, Valencia, 03203, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, 46014, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28009, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Soedersjukhuset
Stockholm, 118 83, Sweden
Universitaetsspital Zuerich
Zurich, 8091, Switzerland
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, 33305, Taiwan
Siriraj Hospital
Bangkok, 10700, Thailand
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, 01370, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06230, Turkey (Türkiye)
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, 06560, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, 06590, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi
Edirne, 22030, Turkey (Türkiye)
Bezmialem Vakif Universitesi Hastanesi
Istanbul, 34093, Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Acibadem Altunizade Hastanesi
Istanbul, 34662, Turkey (Türkiye)
Kartal Dr Lutfi Kirdar Sehir Hastanesi
Istanbul, 34865, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
Konya, 42080, Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Tip Merkezi
Malatya, 44280, Turkey (Türkiye)
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Guys Hospital
London, SE1 9RT, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Sarah Cannon Research Institute UK
London, W1G 6AD, United Kingdom
Maidstone Hospital
Maidstone, ME16 9QQ, United Kingdom
Mount Vernon Cancer Centre
Northwood, HA6 2RN, United Kingdom
Weston Park Hospital
Sheffield, S10 2SJ, United Kingdom
Royal Marsden Hospital - Sutton
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Deming DA. Development of KRAS Inhibitors and Their Role for Metastatic Colorectal Cancer. J Natl Compr Canc Netw. 2025 Jan 3;23(1):e247067. doi: 10.6004/jnccn.2024.7067.
PMID: 39752885DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2024
First Posted
February 12, 2024
Study Start
July 17, 2024
Primary Completion (Estimated)
September 25, 2028
Study Completion (Estimated)
April 25, 2032
Last Updated
June 10, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.