Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation
NCT ID: NCT05198934
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
160 participants
INTERVENTIONAL
2022-04-19
2026-05-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 2 Basket Trial in Which Patients With Advanced Solid Tumors Carrying the KRAS G12C mUtation Receive Treatment With a Combination of Sotorasib and Panitumumab
NCT05993455
Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer
NCT01412957
Study to Evaluate Mechanisms of Acquired Resistance to Panitumumab
NCT00891930
BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)
NCT01750918
A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations
NCT04854434
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: Sotorasib 960 mg QD + panitumumab
Sotorasib
Sotorasib will be administered orally
Panitumumab
Panitumumab will be administered as intravenous (IV) infusion
Arm B: Sotorasib 240 mg QD + panitumumab
Sotorasib
Sotorasib will be administered orally
Panitumumab
Panitumumab will be administered as intravenous (IV) infusion
Arm C : Investigator's choice
Participants will be administered trifluridine and tipiracil, or regorafenib
Trifluridine and Tipiracil
Trifluridine and Tipiracil will be administered orally
Regorafenib
Regorafenib will be administered orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sotorasib
Sotorasib will be administered orally
Panitumumab
Panitumumab will be administered as intravenous (IV) infusion
Trifluridine and Tipiracil
Trifluridine and Tipiracil will be administered orally
Regorafenib
Regorafenib will be administered orally
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥18 years.
* Pathologically documented metastatic colorectal adenocarcinoma with Kirsten rat sarcoma (KRAS) p.G12C mutation as determined by prospective central testing, using the analytically validated Qiagen Therascreen KRAS RGQ polymerase chain reaction Kit in CRC as an investigational device demonstrating a KRAS p.G12C mutation is present. Local testing and documentation of KRAS p.G12C mutation should have been previously performed as part of standard of care.
* Participants will have received at least 1 prior line of therapy for metastatic disease. Participants must have received and progressed or experienced disease recurrence on or after fluoropyrimidine, irinotecan, and oxaliplatin given for metastatic disease unless the participant, in the opinion of the investigator, is not a candidate for fluoropyrimidine, irinotecan, or oxaliplatin, in which case, the participant may be eligible after investigator discussion with Amgen medical monitor provided participant has received at least one prior line of therapy for metastatic disease and provided trifluridine and tipiracil or regorafenib is deemed the appropriate next line of therapy for the participant.
* Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. Lesions previously radiated are not considered measurable unless they have progressed after radiation.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
* Life expectancy of \>3 months, in the opinion of the investigator.
* Adequate hematologic and end-organ function, defined as the following within 2 weeks prior to cycle 1 day 1:
* Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility).
* Hemoglobin ≥9.0 g/dL (without transfusion within 2 weeks of laboratory test used to determine eligibility).
* Platelet count ≥100 x 10\^9/L (without transfusion within 2 weeks of laboratory test used to determine eligibility).
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal (ULN).
* Serum bilirubin ≤1.0 x ULN. For participants with Gilbert's disease, total bilirubin or direct bilirubin needs to be ≤1.0 x ULN.
* International normalized ratio (INR) and activated partial thromboplastin time (or partial thromboplastin time) ≤1.5 x ULN. Prothrombin time (PT) ≤1.5 x ULN may be used instead of INR for sites whose labs do not report INR.
* Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥30 mL/min/1.73 m\^2.
* Fridericia's Correction Formula (QTcF) ≤470 msec.
Exclusion Criteria
* History or presence of hematological malignancies unless curatively treated with no evidence of disease ≥2 years.
* History of other malignancy within the past 3 years, with the following exceptions:
* Malignancy treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated cervical carcinoma in situ without evidence of disease.
* Adequately treated breast ductal carcinoma in situ without evidence of disease.
* Prostatic intraepithelial neoplasia without evidence of prostate cancer.
* Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ.
* Leptomeningeal disease.
* Significant gastrointestinal (GI) disorder that results in significant malabsorption, requirement for intravenous (IV) alimentation, or inability to take oral medication.
* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis.
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 6 months prior to randomization, unstable arrhythmias or unstable angina.
* Previous treatment with a KRAS G12C inhibitor.
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Central Alabama Research
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
University of California Irvine
Orange, California, United States
Johns Hopkins University School of Medicine
Washington D.C., District of Columbia, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Lakes Research LLC
Miami Lakes, Florida, United States
Northwest Georgia Oncology Centers PC
Marietta, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
Revive Research Institute
Farmington Hills, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Revive Research Institute
Sterling Heights, Michigan, United States
Upstate University Hospital
Syracuse, New York, United States
White Plains Hospital Center for Cancer Care
White Plains, New York, United States
Moses H Cone Memorial Hospital
Greensboro, North Carolina, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
Lancaster General Hospital Ann B Barshinger Cancer Institute
Lancaster, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Kelsey Research Foundation
Houston, Texas, United States
Best Cancer Care & Hematology
Houston, Texas, United States
Lumi Research
Kingwood, Texas, United States
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
GenesisCare -North Shore (Oncology)
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot
Lyon Cédex 3, , France
Institut regional du Cancer Montpellier
Montpellier, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hôpital Haut -lévêque
Pessac, , France
Charite Universitaetsmedizin Berlin, Charité Campus Virchow-Klinikum
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
Dresden, , Germany
Universitaetsmedizin Goettingen - Georg-August-Universitaet
Göttingen, , Germany
Klinikum der Universitaet Muenchen Campus Grosshadern
München, , Germany
Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen
Tübingen, , Germany
General Hospital of Athens Laiko
Athens, , Greece
Evgenidio Hospital I Agia Trias
Athens, , Greece
Hygeia Hospital
Athens, , Greece
University Hospital of Heraklion
Heraklion - Crete, , Greece
University Hospital of Patras
Pátrai, , Greece
Theagenion Anticancer Hospital
Thessaloniki, , Greece
Agios Loukas Clinic
Thessaloniki, , Greece
Istituto Ospedaliero Fondazione Poliambulanza
Brescia, , Italy
Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima
Catania, , Italy
Azienda Ospedaliera Santa Croce e Carle
Confreria (CN), , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Ospedale Policlinico San Martino IRCCS
Genova, , Italy
Azienda Sanitaria Locale 5 Spezzino Ospedale S Andrea
La Spezia, , Italy
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
Lecce, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
Monserrato CA, , Italy
Azienda Ospedaliero Universitaria Luigi Vanvitelli
Napoli, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione Giovanni Pascale
Napoli, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, , Italy
Istituto Oncologico Veneto IRCCS
Padua, , Italy
Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara
Pisa, , Italy
Azienda Ospedaliera San Carlo
Potenza, , Italy
Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
Azienda Ospedaliera San Giovanni Addolorata
Roma, , Italy
Fondazione Policlinico Tor Vergata
Roma (RM), , Italy
Azienda Ospedaliera Cardinale Giovanni Panico
Tricase, , Italy
Azienda Unita Locale Socio Sanitaria Berica 8
Vicenza, , Italy
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, Japan
Chiba Cancer Center
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Hyogo Cancer Center
Akashi-shi, Hyōgo, Japan
St Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
National Hospital Organization Osaka National Hospital
Osaka, Osaka, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Saitama Cancer Center
Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Health Pharma Professional Research SA de CV
Mexico City, Mexico City, Mexico
Superare Centro de Infusion SA de CV
Mexico City, Mexico City, Mexico
Trials In Medicine SC
Mexico City, , Mexico
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, Galicia, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Hospital General Universitario de Elche
Elche, Valencia, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, Spain
Hospital Universitario La Paz
Madrid, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan District, , Taiwan
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Maidstone Hospital
Maidstone, , United Kingdom
Mount Vernon Cancer Centre
Northwood, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fakih MG, Salvatore L, Esaki T, Modest DP, Lopez-Bravo DP, Taieb J, Karamouzis MV, Ruiz-Garcia E, Kim TW, Kuboki Y, Meriggi F, Cunningham D, Yeh KH, Chan E, Chao J, Saportas Y, Tran Q, Cremolini C, Pietrantonio F. Sotorasib plus Panitumumab in Refractory Colorectal Cancer with Mutated KRAS G12C. N Engl J Med. 2023 Dec 7;389(23):2125-2139. doi: 10.1056/NEJMoa2308795. Epub 2023 Oct 22.
Pietrantonio F, Salvatore L, Esaki T, Modest DP, Lopez-Bravo DP, Taieb J, Karamouzis MV, Ruiz-Garcia E, Kim TW, Kuboki Y, Meriggi F, Cunningham D, Yeh KH, Chan E, Chao J, Tran Q, Cremolini C, Fakih M. Overall Survival Analysis of the Phase III CodeBreaK 300 Study of Sotorasib Plus Panitumumab Versus Investigator's Choice in Chemorefractory KRAS G12C Colorectal Cancer. J Clin Oncol. 2025 Jul;43(19):2147-2154. doi: 10.1200/JCO-24-02026. Epub 2025 Apr 11.
Modest DP, Fakih M, Salvatore L, Esaki T, Lopez-Bravo DP, Taieb J, Karamouzis M, Ruiz-Garcia E, Kim TW, Kuboki Y, Meriggi F, Cunningham D, Yeh KH, Cremolini C, Tran Q, Chan E, Chao J, Majer IM, Pietrantonio F. Health-related quality of life in patients with KRASG12C-mutated chemorefractory metastatic colorectal cancer treated with sotorasib plus panitumumab or standard of care (CodeBreaK 300): results from a phase 3, randomised clinical trial. Lancet Oncol. 2025 Sep;26(9):1240-1251. doi: 10.1016/S1470-2045(25)00352-3. Epub 2025 Aug 11.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-511187-81-00
Identifier Type: CTIS
Identifier Source: secondary_id
20190172
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.