Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation (CodeBreak300)

A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator's Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib).

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer (CRC)
• Intervention / Treatment: Drug: Sotorasib; Drug: Panitumumab; Drug: Trifluridine and Tipiracil; Drug: Regorafenib

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris Obrien Lifehouse
    • St Leonards, New South Wales, Australia, 2065
      • GenesisCare -North Shore (Oncology)
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
• France
  • Lyon Cédex 3, France, 69437
    • Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot
  • Montpellier, France, 34298
    • Institut régional du Cancer Montpellier
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Pessac, France, 33604
    • Hôpital Haut -lévêque
• Germany
  • Berlin, Germany, 13353
    • Charite Universitaetsmedizin Berlin, Charité Campus Virchow-Klinikum
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden
  • Göttingen, Germany, 37075
    • Universitaetsmedizin Goettingen - Georg-August-Universitaet
  • München, Germany, 81377
    • Klinikum der Universitaet Muenchen Campus Grosshadern
  • Tübingen, Germany, 72076
    • Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen
• Greece
  • Athens, Greece, 11527
    • General Hospital of Athens Laiko
  • Athens, Greece, 15123
    • Hygeia Hospital
  • Athens, Greece, 11528
    • Evgenidio Hospital I Agia Trias
  • Heraklion - Crete, Greece, 71500
    • University Hospital of Heraklion
  • Pátrai, Greece, 26504
    • University Hospital of Patras
  • Thessaloniki, Greece, 55236
    • Agios Loukas Clinic
  • Thessaloniki, Greece, 54007
    • Theagenion Anticancer Hospital
• Italy
  • Brescia, Italy, 25124
    • Istituto Ospedaliero Fondazione Poliambulanza
  • Catania, Italy, 95122
    • Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima
  • Confreria (CN), Italy, 12100
    • Azienda Ospedaliera Santa Croce E Carle
  • Florence, Italy, 50134
    • Azienda Ospedaliera Universitaria Careggi
  • Genova, Italy, 16132
    • Ospedale Policlinico San Martino IRCCS
  • La Spezia, Italy, 19100
    • Azienda Sanitaria Locale 5 Spezzino Ospedale S Andrea
  • Lecce, Italy, 73100
    • Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Milan, Italy, 20162
    • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Monserrato CA, Italy, 09042
    • Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula
  • Naples, Italy, 80131
    • Azienda Ospedaliero Universitaria Luigi Vanvitelli
  • Naples, Italy, 80131
    • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
  • Novara, Italy, 28100
    • Azienda Ospedaliero Universitaria Maggiore della Carità
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto IRCCS
  • Pisa, Italy, 56126
    • Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara
  • Potenza, Italy, 85100
    • Azienda Ospedaliera San Carlo
  • Reggio Emilia, Italy, 42100
    • Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova
  • Roma, Italy, 00168
    • Policlinico Universitario Agostino Gemelli
  • Roma, Italy, 00184
    • Azienda Ospedaliera San Giovanni Addolorata
  • Roma (RM), Italy, 00133
    • Fondazione Policlinico Tor Vergata
  • Tricase, Italy, 73039
    • Azienda Ospedaliera Cardinale Giovanni Panico
  • Vicenza, Italy, 36100
    • Azienda Unita Locale Socio Sanitaria Berica 8
• Japan
  • Aichi-ken
    • Nagakute-shi, Aichi-ken, Japan, 480-1195
      • Aichi Medical University Hospital
  • Chiba
    • Chiba, Chiba, Japan, 260-8717
      • Chiba Cancer Center
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • National Hospital Organization Shikoku Cancer Center
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 811-1395
      • National Hospital Organization Kyushu Cancer Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Hyōgo
    • Akashi-shi, Hyōgo, Japan, 673-8558
      • Hyogo Cancer Center
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • St Marianna University Hospital
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
  • Osaka
    • Osaka, Osaka, Japan, 540-0006
      • National Hospital Organization Osaka National Hospital
    • Suita-shi, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Saitama
    • Kitaadachi-gun, Saitama, Japan, 362-0806
      • Saitama Cancer Center
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
• Mexico
  • Mexico City, Mexico, 06700
    • Trials In Medicine SC
  • Mexico City
    • Mexico City, Mexico City, Mexico, 03100
      • Health Pharma Professional Research SA de CV
    • Mexico City, Mexico City, Mexico, 06760
      • Superare Centro de Infusion SA de CV
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 06351
    • Samsung Medical Center
• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Andalusia
    • Córdoba, Andalusia, Spain, 14004
      • Hospital Universitario Reina Sofia
    • Granada, Andalusia, Spain, 18014
      • Hospital Universitario Virgen de Las Nieves
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marqués de Valdecilla
  • Catalonia
    • Barcelona, Catalonia, Spain, 08041
      • Hospital De La Santa Creu I Sant Pau
    • Barcelona, Catalonia, Spain, 08035
      • Hospital Universitari Vall D Hebron
  • Galicia
    • Ourense, Galicia, Spain, 32005
      • Complexo Hospitalario Universitario de Ourense
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Hospital Universitario de Navarra
  • Valencia
    • Elche, Valencia, Spain, 03203
      • Hospital General Universitario de Elche
    • Valencia, Valencia, Spain, 46014
      • Hospital General Universitario de Valencia
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taoyuan District, Taiwan, 33305
    • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
• United Kingdom
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West of Scotland Cancer Centre
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • Maidstone, United Kingdom, ME16 9QQ
    • Maidstone Hospital
  • Northwood, United Kingdom, HA6 2RN
    • Mount Vernon Cancer Centre
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Central Alabama Research
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • Orange, California, United States, 92868
      • University of California Irvine
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Johns Hopkins University School of Medicine
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialists of North Florida
    • Miami Lakes, Florida, United States, 33014
      • Lakes Research LLC
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers PC
  • Michigan
    • Ann Arbor, Michigan, United States, 48106-0995
      • University of Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Revive Research Institute
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
    • Sterling Heights, Michigan, United States, 48314
      • Revive Research Institute
  • New York
    • Syracuse, New York, United States, 13210
      • Upstate University Hospital
    • White Plains, New York, United States, 10601
      • White Plains Hospital Center for Cancer Care
  • North Carolina
    • Greensboro, North Carolina, United States, 27403
      • Moses H Cone Memorial Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Mark H Zangmeister Center
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Lancaster General Hospital Ann B Barshinger Cancer Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
  • Texas
    • Houston, Texas, United States, 77025
      • Kelsey Research Foundation
    • Houston, Texas, United States, 77089
      • Best Cancer Care & Hematology
    • Kingwood, Texas, United States, 77339
      • Lumi Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures.
• 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:

• Active brain metastases. Participants who have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible if they meet all of the following criteria: a) residual neurological symptoms grade ≤2; b) on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and c) follow-up magnetic resonance imaging (MRI) performed within 28 days of day 1 shows no progression or new lesions appearing.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm C : Investigator's choice; Participants will be administered trifluridine and tipiracil, or regorafenib	Drug: Trifluridine and Tipiracil; Trifluridine and Tipiracil will be administered orally; Other Names: Lonsurf; Drug: Regorafenib; Regorafenib will be administered orally; Other Names: Stivarga
Experimental: Arm A: Sotorasib 960 mg QD + panitumumab	Drug: Sotorasib; Sotorasib will be administered orally; Other Names: AMG 510, Lumakras, Lumykras; Drug: Panitumumab; Panitumumab will be administered as intravenous (IV) infusion; Other Names: Vectibix
Experimental: Arm B: Sotorasib 240 mg QD + panitumumab	Drug: Sotorasib; Sotorasib will be administered orally; Other Names: AMG 510, Lumakras, Lumykras; Drug: Panitumumab; Panitumumab will be administered as intravenous (IV) infusion; Other Names: Vectibix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free Survival (PFS)	Approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Fatigue Severity as Measured by Item 3 of the Brief Fatigue Inventory (BFI)	Item 3 of the BFI records a participants' fatigue on a scale from 0 to 10. Higher scores indicate a higher severity of fatigue. An increase in score from baseline indicates a worsening of fatigue. A decrease in score from baseline indicates an improvement in fatigue.	Baseline and Week 8
Change from Baseline in Pain Severity as Measured by Item 3 of the Brief Pain Inventory (BPI)	Item 3 of the BPI records a participants' pain on a scale from 1 to 10, where pain is mild (score of 1 to 4), moderate (score of 5 to 6), or severe (score of 7 to 10). An increase in score from baseline indicates a worsening of pain. A decrease in score from baseline indicates a lessening of pain.	Baseline and Week 8
Change from Baseline in Physical Functioning as Measured by the Physical Function Domain of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core Questionnaire (EORTC QLQ-C30)	The physical function domain of the EORTC QLQ-C30 assesses a participants' quality of life regarding their physical function on a scale from 1 to 4, with higher scores indicating a worse outcome. An increase in score from baseline indicates a worsening of physical functioning. A decrease in score from baseline indicates an improvement in physical functioning.	Baseline and Week 8
Change from Baseline in Global Health Status as Measured by Questions 29 and 30 of the EORTC QLQ-C30	Questions 29 and 30 of the EORTC QLQ-C30 assess a participants' global health status on a scale from 1 to 7, with higher scores indicating a better outcome. An increase in score from baseline indicates an improvement in global health status. A decrease in score from baseline indicates a worsening in global health status.	Baseline and Week 8
Change from Baseline For All Subscales of the BFI	The BFI is a questionnaire that includes 3 items to assess fatigue severity and 5 items to assess interference due to fatigue, with each item reported on a numeric rating scale from 0 to 10. Higher scores indicate a higher severity of fatigue. An increase in score from baseline indicates a worsening of fatigue. A decrease in score from baseline indicates an improvement in fatigue.	Baseline and Week 8
Change from Baseline For All Subscales of the BPI	The BPI is a 9-item questionnaire which includes 2 body diagrams, four items to assess pain severity, four items to assess pain interference and one question about percentage of pain relief by analgesics. The level of pain and pain interference assessed can be divided into categories based on score of mild (1 to 4), moderate (5 to 6), and severe (7 to 10). An increase in score from baseline indicates a worsening of pain. A decrease in score from baseline indicates a lessening of pain.	Baseline and Week 8
Change from Baseline For All Subscales and Domains of EORTC QLQ-C30	The EORTC QLQ-C30 is a self-reporting 30-item generic instrument which assesses 5 functional domains (physical, role, emotional, cognitive, social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), and a global health status/quality of life (QOL) scale. Higher scores indicate a worse outcome. An increase in score from baseline indicates a worsening of outcome. A decrease in score from baseline indicates an improvement in outcome.	Baseline and Week 8
Change from Baseline in Visual Analog Scale (VAS) Scores as Measured by EuroQol-5D level 5 (EQ-5D-5L)	The EQ-5D-5L questionnaire is a 2-page, standardized instrument for use as a measure of health outcome. It is comprised of a 5-dimension health status measure and a visual analogue scale. The 5-dimension health status measure evaluates: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on a 5-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.	Baseline and Week 8
Average Score on Single Question on Symptom Bother GP5 from Functional Assessment of Cancer Therapy - General (FACT-G)	The GP5 from the FACT-G is a single item included in the Physical Well-Being subscale of the FACT-G. Responses to the item: "I am bothered by side effects of treatment" are rated on a 5-point Likert scale from "not at all" to "very much".	Approximately 2 years
Average Score of Patient Global Impression of Change (PGIC)	The PGIC scale consists of one item which measures the participants' perception of change in their condition relative to the beginning of the study. Responses are rated on a 7-item response scale ranging from very much improved to very much worse.	Approximately 2 years
Maximum Plasma Concentration (Cmax) of Sotorasib		Day 1 to approximately 2 years
Cmax of Panitumumab		Day 1 to approximately 2 years
Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib		Day 1 to approximately 2 years
AUC of Panitumumab		Day 1 to approximately 2 years
Overall Survival (OS)		Approximately 3 years
Objective Response Rate (ORR)		Approximately 3 years
Duration of Response (DOR)		Approximately 3 years
Time to Response (TTR)		Approximately 3 years
Disease Control Rate (DCR)		Approximately 3 years
Investigator Assessed ORR		Approximately 3 years
Investigator Assessed PFS		Approximately 3 years
Number of Participants with a Treatment-emergent Adverse Event (TEAE)	A TEAE is any untoward medical occurrence in a clinical study participant following first dose of treatment irrespective of a causal relationship with the study treatment. Any clinically significant changes in vital signs and clinical laboratory tests following first dose will be recorded as TEAEs.	Approximately 3 years

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• 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.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Actual): July 16, 2025
• Study Completion (Actual): April 14, 2026

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Panitumumab; Metastatic colorectal cancer; Sotorasib; AMG 510; Kirsten rat sarcoma p.G12C mutation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Panitumumab; trifluridine tipiracil drug combination; regorafenib; sotorasib
• Other Study ID Numbers: 20190172; 2024-511187-81-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No