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

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

NCT ID: NCT05198934

Condition: Colorectal Cancer (CRC)

Conditions: Official terms:
Colorectal Neoplasms
Sarcoma
Trifluridine
Panitumumab
Sotorasib

Conditions: Keywords:
Sotorasib
AMG 510
Panitumumab
Metastatic colorectal cancer
Kirsten rat sarcoma p.G12C mutation

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Sotorasib
Description: Sotorasib will be administered orally
Arm group label: Arm A: Sotorasib 960 mg QD + panitumumab
Arm group label: Arm B: Sotorasib 240 mg QD + panitumumab

Other name: AMG 510, Lumakras, Lumykras

Intervention type: Drug
Intervention name: Panitumumab
Description: Panitumumab will be administered as intravenous (IV) infusion
Arm group label: Arm A: Sotorasib 960 mg QD + panitumumab
Arm group label: Arm B: Sotorasib 240 mg QD + panitumumab

Other name: Vectibix

Intervention type: Drug
Intervention name: Trifluridine and Tipiracil
Description: Trifluridine and Tipiracil will be administered orally
Arm group label: Arm C : Investigator's choice

Other name: Lonsurf

Intervention type: Drug
Intervention name: Regorafenib
Description: Regorafenib will be administered orally
Arm group label: Arm C : Investigator's choice

Other name: Stivarga

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).

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 100 Years

Healthy volunteers: No

Locations:

Facility:
Name: Central Alabama Research

Address:
City: Birmingham
Zip: 35209
Country: United States

Facility:
Name: City of Hope National Medical Center

Address:
City: Duarte
Zip: 91010
Country: United States

Facility:
Name: University of California Irvine

Address:
City: Orange
Zip: 92868
Country: United States

Facility:
Name: Johns Hopkins University School of Medicine

Address:
City: Washington
Zip: 20016
Country: United States

Facility:
Name: Cancer Specialists of North Florida

Address:
City: Jacksonville
Zip: 32256
Country: United States

Facility:
Name: Lakes Research LLC

Address:
City: Miami Lakes
Zip: 33014
Country: United States

Facility:
Name: Northwest Georgia Oncology Centers PC

Address:
City: Marietta
Zip: 30060
Country: United States

Facility:
Name: University of Michigan

Address:
City: Ann Arbor
Zip: 48106-0995
Country: United States

Facility:
Name: Revive Research Institute

Address:
City: Farmington Hills
Zip: 48334
Country: United States

Facility:
Name: Sparrow Clinical Research Institute

Address:
City: Lansing
Zip: 48912
Country: United States

Facility:
Name: Revive Research Institute

Address:
City: Sterling Heights
Zip: 48314
Country: United States

Facility:
Name: Upstate University Hospital

Address:
City: Syracuse
Zip: 13210
Country: United States

Facility:
Name: White Plains Hospital Center for Cancer Care

Address:
City: White Plains
Zip: 10601
Country: United States

Facility:
Name: Moses H Cone Memorial Hospital

Address:
City: Greensboro
Zip: 27403
Country: United States

Facility:
Name: The Mark H Zangmeister Center

Address:
City: Columbus
Zip: 43210
Country: United States

Facility:
Name: Lancaster General Hospital Ann B Barshinger Cancer Institute

Address:
City: Lancaster
Zip: 17601
Country: United States

Facility:
Name: Sarah Cannon Research Institute

Address:
City: Nashville
Zip: 37203
Country: United States

Facility:
Name: Kelsey Research Foundation

Address:
City: Houston
Zip: 77025
Country: United States

Facility:
Name: Best Cancer Care & Hematology

Address:
City: Houston
Zip: 77089
Country: United States

Facility:
Name: Lumi Research

Address:
City: Kingwood
Zip: 77339
Country: United States

Facility:
Name: Chris OBrien Lifehouse

Address:
City: Camperdown
Zip: 2050
Country: Australia

Facility:
Name: GenesisCare -North Shore (Oncology)

Address:
City: St Leonards
Zip: 2065
Country: Australia

Facility:
Name: Westmead Hospital

Address:
City: Westmead
Zip: 2145
Country: Australia

Facility:
Name: The Queen Elizabeth Hospital

Address:
City: Woodville South
Zip: 5011
Country: Australia

Facility:
Name: Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot

Address:
City: Lyon Cédex 3
Zip: 69437
Country: France

Facility:
Name: Institut regional du Cancer Montpellier

Address:
City: Montpellier Cedex 5
Zip: 34298
Country: France

Facility:
Name: Hôpital Européen Georges Pompidou

Address:
City: Paris
Zip: 75015
Country: France

Facility:
Name: Hôpital Haut -lévêque

Address:
City: Pessac
Zip: 33604
Country: France

Facility:
Name: Charite Universitaetsmedizin Berlin, Charité Campus Virchow-Klinikum

Address:
City: Berlin
Zip: 13353
Country: Germany

Facility:
Name: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

Address:
City: Dresden
Zip: 01307
Country: Germany

Facility:
Name: Universitaetsmedizin Goettingen - Georg-August-Universitaet

Address:
City: Goettingen
Zip: 37075
Country: Germany

Facility:
Name: Klinikum der Universitaet Muenchen Campus Grosshadern

Address:
City: Muenchen
Zip: 81377
Country: Germany

Facility:
Name: Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen

Address:
City: Tuebingen
Zip: 72076
Country: Germany

Facility:
Name: General Hospital of Athens Laiko

Address:
City: Athens
Zip: 11527
Country: Greece

Facility:
Name: Evgenidio Hospital I Agia Trias

Address:
City: Athens
Zip: 11528
Country: Greece

Facility:
Name: Hygeia Hospital

Address:
City: Athens
Zip: 15123
Country: Greece

Facility:
Name: University Hospital of Heraklion

Address:
City: Heraklion - Crete
Zip: 71500
Country: Greece

Facility:
Name: University Hospital of Patras

Address:
City: Patra
Zip: 26504
Country: Greece

Facility:
Name: Theagenion Anticancer Hospital

Address:
City: Thessaloniki
Zip: 54007
Country: Greece

Facility:
Name: Agios Loukas Clinic

Address:
City: Thessaloniki
Zip: 55236
Country: Greece

Facility:
Name: Istituto Ospedaliero Fondazione Poliambulanza

Address:
City: Brescia
Zip: 25124
Country: Italy

Facility:
Name: Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima

Address:
City: Catania
Zip: 95122
Country: Italy

Facility:
Name: Azienda Ospedaliera Santa Croce e Carle

Address:
City: Confreria (CN)
Zip: 12100
Country: Italy

Facility:
Name: Azienda Ospedaliera Universitaria Careggi

Address:
City: Firenze
Zip: 50134
Country: Italy

Facility:
Name: Ospedale Policlinico San Martino IRCCS

Address:
City: Genova
Zip: 16132
Country: Italy

Facility:
Name: Azienda Sanitaria Locale 5 Spezzino Ospedale S Andrea

Address:
City: La Spezia
Zip: 19100
Country: Italy

Facility:
Name: Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II

Address:
City: Lecce
Zip: 73100
Country: Italy

Facility:
Name: Fondazione IRCCS Istituto Nazionale dei Tumori

Address:
City: Milano
Zip: 20133
Country: Italy

Facility:
Name: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Address:
City: Milano
Zip: 20162
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula

Address:
City: Monserrato CA
Zip: 09042
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria Luigi Vanvitelli

Address:
City: Napoli
Zip: 80131
Country: Italy

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

Address:
City: Napoli
Zip: 80131
Country: Italy

Facility:
Name: Azienda Ospedaliero Universitaria Maggiore della Carita

Address:
City: Novara
Zip: 28100
Country: Italy

Facility:
Name: Istituto Oncologico Veneto IRCCS

Address:
City: Padova
Zip: 35128
Country: Italy

Facility:
Name: Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara

Address:
City: Pisa
Zip: 56126
Country: Italy

Facility:
Name: Azienda Ospedaliera San Carlo

Address:
City: Potenza
Zip: 85100
Country: Italy

Facility:
Name: Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova

Address:
City: Reggio Emilia
Zip: 42100
Country: Italy

Facility:
Name: Fondazione Policlinico Tor Vergata

Address:
City: Roma (RM)
Zip: 00133
Country: Italy

Facility:
Name: Policlinico Universitario Agostino Gemelli

Address:
City: Roma
Zip: 00168
Country: Italy

Facility:
Name: Azienda Ospedaliera San Giovanni Addolorata

Address:
City: Roma
Zip: 00184
Country: Italy

Facility:
Name: Azienda Ospedaliera Cardinale Giovanni Panico

Address:
City: Tricase
Zip: 73039
Country: Italy

Facility:
Name: Azienda Unita Locale Socio Sanitaria Berica 8

Address:
City: Vicenza
Zip: 36100
Country: Italy

Facility:
Name: Aichi Medical University Hospital

Address:
City: Nagakute-shi
Zip: 480-1195
Country: Japan

Facility:
Name: Chiba Cancer Center

Address:
City: Chiba-shi
Zip: 260-8717
Country: Japan

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa-shi
Zip: 277-8577
Country: Japan

Facility:
Name: National Hospital Organization Shikoku Cancer Center

Address:
City: Matsuyama-shi
Zip: 791-0280
Country: Japan

Facility:
Name: National Hospital Organization Kyushu Cancer Center

Address:
City: Fukuoka-shi
Zip: 811-1395
Country: Japan

Facility:
Name: Hokkaido University Hospital

Address:
City: Sapporo
Zip: 060-8648
Country: Japan

Facility:
Name: Hyogo Cancer Center

Address:
City: Akashi-shi
Zip: 673-8558
Country: Japan

Facility:
Name: St Marianna University Hospital

Address:
City: Kawasaki-shi
Zip: 216-8511
Country: Japan

Facility:
Name: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Address:
City: Yokohama-shi
Zip: 241-8515
Country: Japan

Facility:
Name: National Hospital Organization Osaka National Hospital

Address:
City: Osaka-shi
Zip: 540-0006
Country: Japan

Facility:
Name: Osaka University Hospital

Address:
City: Suita-shi
Zip: 565-0871
Country: Japan

Facility:
Name: Saitama Cancer Center

Address:
City: Kitaadachi-gun
Zip: 362-0806
Country: Japan

Facility:
Name: Shizuoka Cancer Center

Address:
City: Sunto-gun
Zip: 411-8777
Country: Japan

Facility:
Name: National Cancer Center Hospital

Address:
City: Chuo-ku
Zip: 104-0045
Country: Japan

Facility:
Name: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Address:
City: Koto-ku
Zip: 135-8550
Country: Japan

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Facility:
Name: Severance Hospital Yonsei University Health System

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Superare Centro de Infusion SA de CV

Address:
City: Ciudad de Mexico
Zip: 06760
Country: Mexico

Facility:
Name: Health Pharma Professional Research SA de CV

Address:
City: Mexico City
Zip: 03100
Country: Mexico

Facility:
Name: Trials In Medicine SC

Address:
City: Ciudad de Mexico
Zip: 06700
Country: Mexico

Facility:
Name: Hospital Universitario Reina Sofia

Address:
City: Cordoba
Zip: 14004
Country: Spain

Facility:
Name: Hospital Universitario Virgen de las Nieves

Address:
City: Granada
Zip: 18014
Country: Spain

Facility:
Name: Hospital Universitario Marques de Valdecilla

Address:
City: Santander
Zip: 39008
Country: Spain

Facility:
Name: Hospital Universitari Vall d Hebron

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital de la Santa Creu i Sant Pau

Address:
City: Barcelona
Zip: 08041
Country: Spain

Facility:
Name: Hospital General Universitario de Elche

Address:
City: Elche
Zip: 03203
Country: Spain

Facility:
Name: Hospital General Universitario de Valencia

Address:
City: Valencia
Zip: 46014
Country: Spain

Facility:
Name: Complexo Hospitalario Universitario de Ourense

Address:
City: Ourense
Zip: 32005
Country: Spain

Facility:
Name: Hospital Universitario de Navarra

Address:
City: Pamplona
Zip: 31008
Country: Spain

Facility:
Name: Hospital Universitario La Paz

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital

Address:
City: Kaohsiung
Zip: 80756
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital

Address:
City: Tainan
Zip: 70403
Country: Taiwan

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Zip: 10002
Country: Taiwan

Facility:
Name: Taipei Veterans General Hospital

Address:
City: Taipei
Zip: 11217
Country: Taiwan

Facility:
Name: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

Address:
City: Taoyuan
Zip: 33305
Country: Taiwan

Facility:
Name: Beatson West of Scotland Cancer Centre

Address:
City: Glasgow
Zip: G12 0YN
Country: United Kingdom

Facility:
Name: Royal Free Hospital

Address:
City: London
Zip: NW3 2QG
Country: United Kingdom

Facility:
Name: Royal Marsden Hospital

Address:
City: London
Zip: SW3 6JJ
Country: United Kingdom

Facility:
Name: Maidstone Hospital

Address:
City: Maidstone
Zip: ME16 9QQ
Country: United Kingdom

Facility:
Name: Mount Vernon Cancer Centre

Address:
City: Northwood
Zip: HA6 2RN
Country: United Kingdom

Facility:
Name: Royal Marsden Hospital

Address:
City: Sutton
Zip: SM2 5PT
Country: United Kingdom

Start date: April 19, 2022

Completion date: March 12, 2025

Lead sponsor:
Agency: Amgen
Agency class: Industry

Source: Amgen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05198934
http://www.amgentrials.com