AzTrials
AzTrials

Metastatic Colorectal CancerPhase 3CodeBreaK 301NCT06252649

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

A Phase 3 study testing FOLFIRI Regimen, Sotorasib and Panitumumab in people with Metastatic Colorectal Cancer, run by Amgen at 291 sites in 35 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
FOLFIRI Regimen, Sotorasib and Panitumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
291 sitesin 35 countries
Study dates
17 Jul 2024to 25 Apr 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

291 sites in 35 countries. Contact the study team or a site near you to ask about taking part.

Amgen Call Center contact

866-572-6436

medinfo@amgen.com

291 sites in 35 countries

United States26 sites, 11 recruiting

  • Georgia Cancer Specialists

    Atlanta, Georgia, 30342

    Terminated

  • Saint Louis Cancer Care West County

    Bridgeton, Missouri, 63044

    Terminated

  • Ironwood Cancer and Research Centers Scottsdale

    Chandler, Arizona, 85224

    Recruiting

  • Insight Research Institute

    Chicago, Illinois, 60616

    Recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Terminated

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Recruiting

  • Providence Saint Jude Medical Center

    Fullerton, California, 92835

    Terminated

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

    Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521

    Terminated

  • Cancer Specialists of North Florida - Southpoint

    Jacksonville, Florida, 32256

    Recruiting

  • City of Hope National Medical Center

    Long Beach, California, 90813

    Recruiting

  • Cancer and Blood Research Center, LLC

    Los Alamitos, California, 90720

    Recruiting

  • California Research Institute

    Los Angeles, California, 90027

    Terminated

  • D and H Cancer Research Center

    Margate, Florida, 33063

    Terminated

  • Minniti Center for Medical Oncology and Hematology

    Mickleton, New Jersey, 08056

    Terminated

  • Tennessee Oncology PLLC - Chattanooga

    Nashville, Tennessee, 37203

    Recruiting

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Recruiting

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

    Terminated

  • Mid Florida Hematology and Oncology Centers PA

    Orange City, Florida, 32763

    Terminated

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Terminated

  • Pikeville Medical Center

    Pikeville, Kentucky, 41501

    Recruiting

  • FirstHealth Cancer Center

    Pinehurst, North Carolina, 28374

    Terminated

  • Boca Raton Clinical Research Medical Center Inc

    Plantation, Florida, 33322

    Terminated

  • Carolina Blood and Cancer Care

    Rock Hill, South Carolina, 29732

    Terminated

  • Orchard Healthcare Research Inc

    Skokie, Illinois, 60076

    Terminated

Other trials in United States

Japan21 sites, 21 recruiting

  • Hyogo Cancer Center

    Akashi-shi, Hyōgo, 673-8558

    Recruiting

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603

    Recruiting

  • Tokyo Metropolitan Komagome Hospital

    Bunkyo-ku, Tokyo, 113-8677

    Recruiting

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

    Recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

    Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

    Recruiting

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, 573-1191

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

    Recruiting

  • St Marianna University Hospital

    Kawasaki-shi, Kanagawa, 216-8511

    Recruiting

  • Saitama Cancer Center

    Kitaadachi-gun, Saitama, 362-0806

    Recruiting

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

    Recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

    Recruiting

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

    Recruiting

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

    Recruiting

  • National Hospital Organization Osaka National Hospital

    Osaka, Osaka, 540-0006

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Recruiting

  • The University of Osaka Hospital

    Suita-shi, Osaka, 565-0871

    Recruiting

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

    Recruiting

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

    Recruiting

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

    Recruiting

Other trials in Japan

Spain20 sites, 19 recruiting

  • Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

    Badalona, Catalonia, 08916

    Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

    Recruiting

  • Hospital Universitario de Burgos

    Burgos, Castille and León, 09006

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

    Recruiting

  • Hospital General Universitario de Elche

    Elche, Valencia, 03203

    Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia, 18014

    Recruiting

  • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Catalonia, 08908

    Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Terminated

  • Hospital Universitario La Paz

    Madrid, 28046

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, Andalusia, 29010

    Recruiting

  • Complexo Hospitalario Universitario de Ourense

    Ourense, Galicia, 32005

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

    Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, Valencia, 46010

    Recruiting

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon, 50009

    Recruiting

Other trials in Spain

Italy19 sites, 15 recruiting

  • Istituto Ospedaliero Fondazione Poliambulanza

    Brescia, 25124

    Recruiting

  • Ente Ospedaliero IRCCS Saverio De Bellis

    Castellana Grotte, 70013

    Terminated

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

    Recruiting

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    Foggia, 71100

    Terminated

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132

    Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    Meldola FC, 47014

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Recruiting

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Recruiting

  • Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi

    Naples, 80131

    Recruiting

  • Istituto Nazionale dei Tumori IRCCS Fondazione Giovanni Pascale

    Naples, 80131

    Recruiting

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

    Recruiting

  • Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

    Palermo, 90127

    Recruiting

  • Azienda Sanitaria Territoriale Pesaro Urbino - Presidio San Salvatore Muraglia

    Pesaro, 61122

    Terminated

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

    Recruiting

  • Azienda Unità Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna

    Ravenna, 48121

    Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano MI, 20089

    Recruiting

  • Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

    Recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale Presidio Ospedaliero Santa Maria della Misericordia

    Udine, 33100

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata di Verona Ospedale Civile Maggiore Borgo Trento

    Verona, 37126

    Terminated

Other trials in Italy

Brazil16 sites, 13 recruiting

  • Fundacao pio xII Barretos

    Barretos, São Paulo, 14784-400

    Recruiting

  • Oncoclinicas Belo Horizonte

    Barretos, São Paulo, 14784-400

    Recruiting

  • Hospital Sirio Libanes Brasilia

    Brasília, Federal District, 70200-730

    Recruiting

  • Hospital Evangelico de Cachoeiro de Itapemirim

    Cachoeiro de Itapemirim, Espírito Santo, 29308-020

    Recruiting

  • Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000

    Recruiting

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220

    Terminated

  • Liga Norte-Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59075-740

    Recruiting

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

    Recruiting

  • Associação Hospitalar Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90560-030

    Recruiting

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250-205

    Terminated

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

    Recruiting

  • Fundacao Antonio Prudente AC Camargo Cancer Center

    São Paulo, São Paulo, 01246-000

    Terminated

  • Instituto Cancer Sao Paulo Icesp

    São Paulo, 01246-000

    Recruiting

  • Instituto Brasileiro de Controle do Cancer Ibcc

    São Paulo, 04014-002

    Recruiting

  • Oncologia Rede D Or

    São Paulo, 04501-000

    Recruiting

  • Vencer e Oncoclinica

    Teresina, Piauí, 64049-200

    Recruiting

Other trials in Brazil

France16 sites, 16 recruiting

  • Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing

    Clermont-Ferrand, 63003

    Recruiting

  • Hopital Henri Mondor

    Créteil, 94000

    Recruiting

  • Centre Hospitalier Universitaire de Dijon - Hopital du Bocage

    Dijon, 21079

    Recruiting

  • Hopital Prive Jean Mermoz

    Lyon, 69008

    Recruiting

  • Institut regional du Cancer Montpellier

    Montpellier, 34298

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Recruiting

  • Hopital Europeen Georges Pompidou

    Paris, 75015

    Recruiting

  • Hopital Saint Louis

    Paris, 75475

    Recruiting

  • Hopital Pitie-Salpetriere

    Paris, 75651

    Recruiting

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

    Pessac, 33604

    Recruiting

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

    Recruiting

  • Hopital Robert Debre

    Reims, 51092

    Recruiting

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033

    Recruiting

  • Institut de Cancerologie de l Ouest Rene Gauducheau

    Saint-Herblain, 44805

    Recruiting

  • Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord

    Saint-Priest-en-Jarez, 42270

    Recruiting

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    Recruiting

Other trials in France

Argentina13 sites, 10 recruiting

  • Hospital Britanico de Buenos Aires

    Buenos Aires, C1280AEB

    Recruiting

  • Hospital Universitario Fundacion Favaloro

    CABA, Buenos Aires, C1093AAS

    Recruiting

  • Instituto Argentino de Diagnóstico y Tratamiento

    CABA, Buenos Aires, C1093AAS

    Recruiting

  • Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL

    CABA, Buenos Aires, C1425BGH

    Recruiting

  • Cemic

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO

    Terminated

  • Hospital Italiano de Córdoba

    Córdoba, Córdoba Province, 5000

    Recruiting

  • Sanatorio Allende

    Córdoba, Córdoba Province, X5000JHQ

    Terminated

  • Clinica Universitaria Privada Reina Fabiola

    Córdoba, Córdoba Province, X5004FHP

    Recruiting

  • Sanatorio Británico de Rosario

    La Plata, Buenos Aires, 1900

    Recruiting

  • Centro Oncologico Riojano Integral

    La Rioja, F5300COE

    Terminated

  • Instituto de Investigaciones clinicas de Mar del Plata

    Mar del Plata, Buenos Aires, B7600FZO

    Recruiting

  • Exelsus Oncologia Clinica

    San Miguel de Tucumán, Tucumán Province, 4000

    Recruiting

  • Clinica Viedma

    Viedma, Río Negro Province, 8500

    Recruiting

Other trials in Argentina

Turkey (Türkiye)13 sites, 10 recruiting

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Adana, 01370

    Recruiting

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06230

    Recruiting

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06560

    Recruiting

  • Ankara Universitesi Tip Fakultesi Hastanesi

    Ankara, 06590

    Recruiting

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

    Recruiting

  • Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

    Edirne, 22030

    Recruiting

  • Bezmialem Vakif Universitesi Hastanesi

    Istanbul, 34093

    Terminated

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214

    Terminated

  • Acibadem Altunizade Hastanesi

    Istanbul, 34662

    Terminated

  • Kartal Dr Lutfi Kirdar Sehir Hastanesi

    Istanbul, 34865

    Recruiting

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

    Recruiting

  • Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi

    Konya, 42080

    Recruiting

  • Inonu Universitesi Turgut Ozal Tip Merkezi

    Malatya, 44280

    Recruiting

Other trials in Turkey (Türkiye)

Greece11 sites, 7 recruiting

  • General Hospital Evangelismos

    Athens, 10676

    Terminated

  • Agios Savvas Anticancer Hospital

    Athens, 11522

    Terminated

  • Athens Medical Center S.A - Psychikon

    Athens, 11525

    Recruiting

  • Aretaieio Hospital

    Athens, 11528

    Recruiting

  • Hygeia Hospital

    Athens, 15123

    Recruiting

  • Metropolitan Hospital

    Athens, 18547

    Terminated

  • University Hospital of Larissa

    Larissa, 41110

    Recruiting

  • Metaxa Anticancer Hospital

    Piraeus, 18537

    Recruiting

  • Genesis Idiotiki Geniki Maieutiki Gynaikologiki Kliniki S.A.

    Pylaia, Thessaloniki, 55535

    Recruiting

  • Saint Lukes Hospital SA

    Thessaloniki, 55236

    Terminated

  • European Interbalkan Medical Center

    Thessaloniki, 57001

    Recruiting

Other trials in Greece

Germany10 sites, 6 recruiting

  • Charite - Universitaetsmedizin Berlin, Campus Virchow

    Berlin, 13353

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

    Recruiting

  • Universitaetsklinikum Dresden

    Dresden, 01307

    Recruiting

  • Universitaetsklinikum Essen

    Essen, 45147

    Recruiting

  • UCT Universitaeres Zentrum fuer Tumorerkrankungen Frankfurt

    Frankfurt am Main, 60488

    Terminated

  • Haematologisch Onkologische Praxis Eppendorf

    Hamburg, 20246

    Terminated

  • Regional Kliniken Holding Klinikum Ludwigsburg

    Ludwigsburg, 71640

    Terminated

  • Klinikum der LMU Muenchen

    München, 81377

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89081

    Terminated

  • Klinikum der Stadt Wolfsburg

    Wolfsburg, 38440

    Recruiting

Other trials in Germany

United Kingdom10 sites, 10 recruiting

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2TH

    Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

    Recruiting

  • Royal Free Hospital

    London, NW3 2QG

    Recruiting

  • Guys Hospital

    London, SE1 9RT

    Recruiting

  • Royal Marsden Hospital

    London, SW3 6JJ

    Recruiting

  • Sarah Cannon Research Institute UK

    London, W1G 6AD

    Recruiting

  • Maidstone Hospital

    Maidstone, ME16 9QQ

    Recruiting

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN

    Recruiting

  • Weston Park Hospital

    Sheffield, S10 2SJ

    Recruiting

  • Royal Marsden Hospital - Sutton

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

Portugal9 sites, 9 recruiting

  • Unidade Local de Saude de Almada-Seixal, EPE - Hospital Garcia de Orta

    Almada, 2801-951

    Recruiting

  • Instituto Portugues de Oncologia de Coimbra Francisco Gentil, EPE

    Coimbra, 3001-651

    Recruiting

  • Unidade Local de Saude de Coimbra, EPE

    Coimbra, 3004-561

    Recruiting

  • Hospital Cuf Tejo

    Lisbon, 1350-352

    Recruiting

  • Fundacao Champalimaud

    Lisbon, 1400-038

    Recruiting

  • Hospital da Luz, SA

    Lisbon, 1500-650

    Recruiting

  • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

    Lisbon, 1649-035

    Recruiting

  • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

    Matosinhos Municipality, 4464-513

    Recruiting

  • Unidade Local de Saude de Entre Douro e Vouga, EPE - Hospital de Sao Sebastiao

    Santa Maria da Feira, 4520-211

    Recruiting

Other trials in Portugal

Belgium8 sites, 7 recruiting

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200

    Recruiting

  • Institut Jules Bordet

    Brussels, B-1070

    Recruiting

  • Grand Hôpital de Charleroi - Site des Viviers

    Charleroi, 6060

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Recruiting

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

    Recruiting

  • Algemeen Ziekenhuis Sint Maarten-Emmaus vzw

    Mechelen, 2800

    Recruiting

  • AZ Delta Campus Rumbeke

    Roeselare, 8800

    Recruiting

  • Vitaz campus Sint-Niklaas Moerland

    Sint-Niklaas, 9100

    Terminated

Other trials in Belgium

Chile8 sites, 3 recruiting

  • Enroll SpA

    Providencia, Santiago Metropolitan, 7500587

    Terminated

  • Fundacion Arturo Lopez Perez

    Santiago, 7500921

    Recruiting

  • Centro de Oncologia de Precision (Medicina de Precision Celerity)

    Santiago, 7560907

    Recruiting

  • Biocinetic servicios medicos limitada

    Santiago, 8330336

    Terminated

  • James Lind Centro de Investigacion del Cancer

    Temuco, Cautín, 4800827

    Recruiting

  • Centro de investigacion y desarrollo oncolgico Spa

    Temuco, Cautín, 4810218

    Terminated

  • Clinical Research Chile SpA

    Valdivia, 5110683

    Terminated

  • Clinica Redsalud Vitacura, Instituto del Cancer

    Vitacura, Santiago Metropolitan, 7650018

    Terminated

Other trials in Chile

Poland8 sites, 8 recruiting

  • Szpitale Pomorskie spolka z ograniczona odpowiedzialnoscia

    Gdynia, 81-519

    Recruiting

  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach

    Kielce, 25-734

    Recruiting

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

    Lodz, 93-513

    Recruiting

  • SPZOZ Opolskie Centrum Onkologii imienia prof Tadeusza Koszarowskiego w Opolu

    Opole, 45-061

    Recruiting

  • Wielkopolskie Centrum Onkologii imienia Marii Sklodowskiej-Curie

    Poznan, 61-866

    Recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

    Warsaw, 02-034

    Recruiting

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

    Warsaw, 02-507

    Recruiting

  • Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy

    Warsaw, 04-141

    Recruiting

Other trials in Poland

South Korea8 sites, 4 recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

    Recruiting

  • Korea University Anam Hospital

    Seoul, 02841

    Terminated

  • Seoul National University Hospital

    Seoul, 03080

    Terminated

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

    Terminated

  • Korea University Guro Hospital

    Seoul, 08308

    Terminated

  • Asan Medical Center

    Seoul, 138-736

    Recruiting

Other trials in South Korea

Hungary7 sites, 6 recruiting

  • Semmelweis Egyetem

    Budapest, 1083

    Recruiting

  • Orszagos Onkologiai Intezet

    Budapest, 1122

    Recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

    Recruiting

  • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700

    Recruiting

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

    Recruiting

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

    Nyíregyháza, 4400

    Terminated

  • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, 5000

    Recruiting

Other trials in Hungary

Romania7 sites, 7 recruiting

  • Institutul Clinic Fundeni

    Bucharest, 022328

    Recruiting

  • Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti

    Bucharest, 022338

    Recruiting

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015

    Recruiting

  • Centrul de Oncologie Sf Nectarie SRL

    Craiova, 200542

    Recruiting

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

    Recruiting

  • Spitalul Municipal Ploiesti

    Ploieşti, 100337

    Recruiting

  • SC Oncomed SRL

    Timișoara, 300239

    Recruiting

Other trials in Romania

Australia6 sites, 5 recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

    Recruiting

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050

    Recruiting

  • Austin Health, Austin Hospital

    Heidelberg, Victoria, 3084

    Terminated

  • Toowoomba Hospital

    Toowoomba, Queensland, 4350

    Recruiting

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Recruiting

Other trials in Australia

Canada6 sites, 6 recruiting

  • William Osler Health System - Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

    Recruiting

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Recruiting

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

    Recruiting

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

    Recruiting

  • Sunnybrook Research Institute Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Recruiting

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

    Recruiting

Other trials in Canada

Colombia6 sites, 4 recruiting

  • Instituto Nacional de Cancerologia

    Bogota, Cundinamarca, 111711

    Recruiting

  • Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic

    Bogotá, Cundinamarca, 110131

    Terminated

  • Fundacion Oftalmologica de Santander - Foscal

    Floridablanca, Santander Department, 681004

    Terminated

  • Servicios de Salud Ips Suramericana Sas - Ips Sura Industriales

    Medellín, Antioquia, 050030

    Recruiting

  • Instituto Medico de Alta Tecnologia sas - Imat sas

    Montería, Departamento de Córdoba, 230018

    Recruiting

  • Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA

    Rionegro, Antioquia, 054040

    Recruiting

Other trials in Colombia

Czechia6 sites, 6 recruiting

  • Masarykuv onkologicky ustav

    Brno, 656 53

    Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

    Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

    Recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

    Recruiting

  • Fakultni nemocnice v Motole

    Prague, 150 06

    Recruiting

  • Fakultni nemocnice Bulovka

    Prague, 180 81

    Recruiting

Other trials in Czechia

Netherlands6 sites, 6 recruiting

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek

    Amsterdam, 1066 CX

    Recruiting

  • Albert Schweitzer Ziekenhuis, Locatie Dordwijk

    Dordrecht, 3318 AT

    Recruiting

  • Medisch Spectrum Twente

    Enschede, 7512 KZ

    Recruiting

  • Martini Ziekenhuis

    Groningen, 9728 NT

    Recruiting

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX

    Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

Austria5 sites, 3 recruiting

  • Medizinische Universitaet Graz

    Graz, 8036

    Recruiting

  • Ordensklinikum Linz Barmherzige Schwestern

    Linz, 4010

    Recruiting

  • Landeskrankenhaus Feldkirch

    Rankweil, 6830

    Terminated

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090

    Terminated

  • Krankenhaus Wiener Neustadt

    Wiener Neustadt, 2700

    Recruiting

Other trials in Austria

Bulgaria5 sites, 2 recruiting

  • Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD

    Haskovo, 6300

    Terminated

  • Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

    Plovdiv, 4000

    Terminated

  • Complex Oncology Center Plovdiv EOOD

    Plovdiv, 4004

    Terminated

  • Multiprofile Hospital for Active Treatment Serdikamed EOOD

    Sofia, 1303

    Recruiting

  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

    Sofia, 1606

    Recruiting

Other trials in Bulgaria

Denmark4 sites, 4 recruiting

  • Aalborg Sygehus

    Aalborg, 9000

    Recruiting

  • Aarhus University Hospital

    Aarhus N, 8200

    Recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Recruiting

  • Odense University Hospital

    Odense C, 5000

    Recruiting

Other trials in Denmark

Mexico4 sites, 3 recruiting

  • Centro Especializado en Investigacion y Tratamiento Oncologicos SC

    Benito Juárez, Mexico City, 03104

    Recruiting

  • Health Pharma Professional Research SA de CV

    Mexico City, Mexico City, 03100

    Recruiting

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080

    Recruiting

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

    Terminated

Other trials in Mexico

Taiwan4 sites, 4 recruiting

  • China Medical University Hospital

    Taichung, 40447

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

    Taoyuan, 33305

    Recruiting

Other trials in Taiwan

Hong Kong3 sites, 2 recruiting

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

    Recruiting

  • Princess Margaret Hospital

    Kowloon

    Terminated

  • Tuen Mun Hospital

    New Territories

    Recruiting

Other trials in Hong Kong

Estonia1 site

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

    Active, not recruiting

Other trials in Estonia

Puerto Rico1 site, 1 recruiting

  • Pan American Center for Oncology Trials LLC

    Rio Piedras, 00935

    Recruiting

Other trials in Puerto Rico

Slovakia1 site, 1 recruiting

  • Vychodoslovensky onkologicky ustav, as

    Košice, 041 90

    Recruiting

Other trials in Slovakia

Sweden1 site, 1 recruiting

  • Soedersjukhuset

    Stockholm, 118 83

    Recruiting

Other trials in Sweden

Switzerland1 site

  • Universitaetsspital Zuerich

    Zurich, 8091

    Active, not recruiting

Other trials in Switzerland

Thailand1 site, 1 recruiting

  • Siriraj Hospital

    Bangkok, 10700

    Recruiting

Other trials in Thailand

About this study

Official title: 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)

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.

Being tested
FOLFIRI Regimen, Sotorasib, Panitumumab, Bevacizumab-awwb
Keywords
Sotorasib, Panitumumab, FOLFIRI, Bevacizumab-awwb, Oncology
Medical subject headings
Colorectal Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFIRI RegimenDrug

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

  • SotorasibDrug

    Also called AMG 510, Lumakras, Lumykras

    Immediate-release solid dosage form administered orally.

  • PanitumumabDrug

    Also called Vectibix

    Administered via IV infusion Q2W.

  • Bevacizumab-awwbDrug

    Also called MVASI

    Administered via IV infusion Q2W.

Study groups in NCT06252649
Study groupRoleWhat they receive
Arm A: Sotorasib + Panitumumab + FOLFIRIExperimentalSotorasib will be taken daily (QD) as an oral tablet. Panitumumab and FOLFIRI will be received every 2 weeks (Q2W) via intravenous (IV) infusion.
Receives: Drug: FOLFIRI Regimen; Drug: Sotorasib; Drug: Panitumumab
Arm B: FOLFIRI with or Without Bevacizumab-awwbActive comparatorParticipants will receive FOLFIRI Q2W with or without bevacizumab-awwb.
Receives: Drug: FOLFIRI Regimen; Drug: Bevacizumab-awwb

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Measured: Up to Approximately 3 Years

Secondary outcomes (18)

  1. Overall Survival (OS)

    Measured: Up to Approximately 5 Years

  2. Objective Response Rate (ORR) per RECIST v1.1

    Measured: Up to Approximately 5 Years

  3. Objective Response (OR) per RECIST v1.1

    Measured: Up to Approximately 5 Years

  4. Duration of Response (DOR) per RECIST v1.1

    Measured: Up to Approximately 5 Years

  5. Disease Control Rate (DCR) per RECIST v1.1

    Measured: Up to Approximately 5 Years

  6. Time to Response (TTR) per RECIST v1.1

    Measured: Up to Approximately 5 Years

  7. Depth of Response per RECIST v1.1

    Depth of response is measured as the percentage of tumor shrinkage calculated as the best percentage change from baseline in lesion sum diameters.

    Measured: Up to Approximately 5 Years

  8. Time to Early Tumor Shrinkage (ETS) per RECIST v1.1

    Measured: Up to Approximately 5 Years

  9. PFS Based on Investigator's Assessment per RECIST v1.1

    Measured: Up to Approximately 5 Years

  10. ORR Based on Investigator's Assessment per RECIST v1.1

    Measured: Up to Approximately 5 Years

  11. DOR Based on Investigator's Assessment per RECIST v1.1

    Measured: Up to Approximately 5 Years

  12. DCR Based on Investigator's Assessment per RECIST v1.1

    Measured: Up to Approximately 5 Years

  13. TTR Based on Investigator's Assessment per RECIST v1.1

    Measured: Up to Approximately 5 Years

  14. Depth of Response Based on Investigator's Assessment per RECIST v1.1

    Measured: Up to Approximately 5 Years

  15. Time to ETS Based on Investigator's Assessment per RECIST v1.1

    Measured: Up to Approximately 5 Years

  16. Number of Participants Experiencing Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measured: Up to Approximately 5 Years

  17. Pre-dose (Ctrough) Concentrations of Sotorasib

    Measured: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)

  18. Maximum Plasma Concentration (Cmax) of Sotorasib

    Measured: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start17 Jul 2024
  3. Primary completion25 Sep 2028 (estimated)
  4. Study completion25 Apr 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06252649
Sponsor's protocol ID
20210081
Acronym
CodeBreaK 301
Status last verified
Sep 2026
First submitted
15 Jan 2024
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

  • 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.

    PubMed 39752885

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FOLFIRI Regimen, Sotorasib and Panitumumab in people with Metastatic Colorectal Cancer, run by Amgen at 291 sites in 35 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 291 sites in United States, Japan, Spain, Italy, Brazil and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (time frame: Up to Approximately 3 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06252649, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in