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ACTIVE NOT RECRUITING

NCT05198934

PHASE3

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

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2022-04-19

Completion Date

2026-05-14

Last Updated

2026-02-06

Healthy Volunteers

Conditions

Colorectal Cancer (CRC)

Interventions

DRUG

Sotorasib

Sotorasib will be administered orally

DRUG

Panitumumab

Panitumumab will be administered as intravenous (IV) infusion

DRUG

Trifluridine and Tipiracil

Trifluridine and Tipiracil will be administered orally

DRUG

Regorafenib

Regorafenib will be administered orally

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.

Locations (105)

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

Naples, Italy

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione Giovanni Pascale

Naples, Italy

Azienda Ospedaliero Universitaria Maggiore della Carita

Novara, Italy

Istituto Oncologico Veneto IRCCS

Padova, 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (105)