A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

Last updated: April 25, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

5-fluorouracil

Irinotecan Hydrochloride

Oxaliplatin

Clinical Study ID

NCT06662786
61186372COR3001
2024-513852-13-00
61186372COR3001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have histologically or cytologically confirmed adenocarcinoma of the left-sidedcolorectal cancer. Participants must have unresectable or metastatic disease

  • Be diagnosed to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RASviral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor as determined by local testing

  • Must agree to the submission of fresh tumor tissue

  • Have measurable disease according to RECIST v1.1

  • Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1

Exclusion

Exclusion Criteria:

  • Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis,or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imagingat screening

  • Has known allergies, hypersensitivity, or intolerance to excipients of any of thefollowing: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) anycomponent of FOLFIRI

  • Has a prior or concurrent second malignancy other than the disease under study orone whose natural history or treatment is unlikely to interfere with any studyendpoints of safety or the efficacy of the study treatment(s)

  • Participant with known mismatch repair deficiency (dMMR)/ high microsatelliteinstability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor

  • Has prior exposure to any agents that target epidermal growth factor receptor (EGFR)or mesenchymal epithelial transition (MET)

Study Design

Total Participants: 1000
Treatment Group(s): 6
Primary Treatment: 5-fluorouracil
Phase: 3
Study Start date:
October 18, 2024
Estimated Completion Date:
December 15, 2032

Connect with a study center

  • Institut Jules Bordet

    Anderlecht, 1070
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650
    Belgium

    Active - Recruiting

  • AZ Maria Middelares

    Gent, 9000
    Belgium

    Active - Recruiting

  • Hopital de Jolimont

    Haine Saint Paul La Louviere, 7100
    Belgium

    Active - Recruiting

  • Az Groeninge

    Kortrijk, 8500
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Fundacao Pio XII

    Barretos, 14780 070
    Brazil

    Active - Recruiting

  • Fundacao Universidade de Caxias do Sul

    Caxias do Sul, 95070 560
    Brazil

    Active - Recruiting

  • Fundacao Doutor Amaral Carvalho

    Jau, 17210 080
    Brazil

    Active - Recruiting

  • Hospital Santa Izabel Santa Casa de Misericordia da Bahia

    Salvador, 40050 410
    Brazil

    Active - Recruiting

  • Clinica de Hematologia e Oncologia Viver Ltda

    Santa Maria, 97015 450
    Brazil

    Active - Recruiting

  • Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base

    Sao Jose do Rio Preto, 15090 000
    Brazil

    Active - Recruiting

  • Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base

    Sao Jose do Rio Preto, 15090 000
    Brazil

    Active - Recruiting

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    Sao Paulo, 01509 900
    Brazil

    Active - Recruiting

  • Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia

    Vitoria, 29043 260
    Brazil

    Active - Recruiting

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta T2N 5G2
    Canada

    Active - Recruiting

  • Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G1X6
    Canada

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Active - Recruiting

  • Beijing Friendship Hospital Capital Medical University

    Beijing, 100050
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, 100034
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, 100191
    China

    Active - Recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, 130021
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, 519041
    China

    Active - Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510062
    China

    Active - Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510062
    China

    Active - Recruiting

  • The Sixth Affiliated Hospital Sun Yat sen University

    Guangzhou, 510655
    China

    Active - Recruiting

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, 310009
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022
    China

    Active - Recruiting

  • Huizhou Central People's Hospital

    Huizhou, 516001
    China

    Active - Recruiting

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032
    China

    Active - Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, 518036
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Sichuan, 610044
    China

    Active - Recruiting

  • First Hospital of Shanxi Medical University

    Taiyuan, 030001
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, 430079
    China

    Active - Recruiting

  • Institut Sainte Catherine

    Avignon Cedex 9, 84918
    France

    Active - Recruiting

  • Hopital Claude Huriez

    Lille, 59000
    France

    Active - Recruiting

  • Hopital Prive Jean Mermoz

    Lyon, 69008
    France

    Active - Recruiting

  • Institut du Cancer de Montpellier

    Montpellier, 34298
    France

    Active - Recruiting

  • CHU Nantes

    Nantes Cedex 1, 44000
    France

    Active - Recruiting

  • Hopital Saint Antoine

    Paris, 75571
    France

    Active - Recruiting

  • Hopital Haut Leveque

    Pessac, 33604
    France

    Active - Recruiting

  • CHU De Poitiers

    Poitiers Cedex, 86000
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum

    Berlin, 13353
    Germany

    Active - Recruiting

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • Essen University Hospital

    Essen, 45147
    Germany

    Active - Recruiting

  • Krankenhaus NorthWest

    Frankfurt am Main, 60488
    Germany

    Active - Recruiting

  • Praxis fur interdisziplinare Onkologie & Hamatologie GbR

    Freiburg, 79110
    Germany

    Active - Recruiting

  • Asklepios Klinik Altona

    Hamburg, 22763
    Germany

    Active - Recruiting

  • Klinikum der Universitaet Muenchen

    Munich, 81377
    Germany

    Active - Recruiting

  • Universitatsklinikum Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • Semmelweis Egyetem

    Budapest, 1082
    Hungary

    Active - Recruiting

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, 3300
    Hungary

    Active - Recruiting

  • Pecsi Tudomanyegyetem

    Pecs, 7624
    Hungary

    Active - Recruiting

  • Rajiv Gandhi Cancer Institute and Research Centre

    Delhi, 110085
    India

    Active - Recruiting

  • B P Poddar Hospital and Medical research Limited

    Kolkata, 700053
    India

    Active - Recruiting

  • Tata Memorial Hospital

    Mumbai, 400012
    India

    Active - Recruiting

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, 411004
    India

    Active - Recruiting

  • Yitzhak Shamir Medical Center

    Beer Yaakov, 70300
    Israel

    Active - Recruiting

  • Rambam Medical Center

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Hadassah University Hospita Ein Kerem

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Active - Recruiting

  • Assuta MC

    Tel Aviv Yafo, 69710
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv Yafo, 6423906
    Israel

    Active - Recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014
    Italy

    Active - Recruiting

  • Istituto Dei Tumori Di Milano

    Milano, 20133
    Italy

    Active - Recruiting

  • Istituto Oncologico Veneto - IRCCS

    Padova, 35128
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Chiba Cancer Center

    Chiba, 260 0801
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo Ku, 104 0045
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277 8577
    Japan

    Active - Recruiting

  • Aichi Cancer Center

    Nagoya Shi, 464 8681
    Japan

    Active - Recruiting

  • Osaka International Cancer Institute

    Osaka City, 541 8567
    Japan

    Active - Recruiting

  • National Hospital Organization Osaka National Hospital

    Osaka-Shi, 540 0006
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Shizuoka, 411 8777
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita, 565 0871
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550
    Japan

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • Hospital Canselor Tuanku Muhriz UKM

    Cheras, 56000
    Malaysia

    Active - Recruiting

  • Hospital Pulau Pinang

    Georgetown, 10450
    Malaysia

    Active - Recruiting

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30450
    Malaysia

    Active - Recruiting

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586
    Malaysia

    Active - Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

  • Hospital Umum Sarawak

    Kuching, 93586
    Malaysia

    Active - Recruiting

  • National Cancer Institute

    Putrajaya, 62250
    Malaysia

    Active - Recruiting

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ
    Netherlands

    Active - Recruiting

  • Radboud University Medical Center

    Nijmegen, 6525 GA
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, 5022 GC
    Netherlands

    Active - Recruiting

  • Wojewodzki Szpital Specjalistyczny

    Biala Podlaska, 21 500
    Poland

    Active - Recruiting

  • Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku

    Bialystok, 15 027
    Poland

    Active - Recruiting

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

    Brzozow, 36 200
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach

    Gliwice, 44 100
    Poland

    Active - Recruiting

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93 339
    Poland

    Active - Recruiting

  • SPZOZ Ministerstwa Spraw Wewnetrznych z Warminsko Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn, 10 228
    Poland

    Active - Recruiting

  • SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego

    Opole, 45 061
    Poland

    Active - Recruiting

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

    Warszawa, 02 781
    Poland

    Active - Recruiting

  • Pan American Center for Oncology Trials LLC

    Barrio Monacillos, 00935
    Puerto Rico

    Active - Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hosp. Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Sahlgrenska University Hospital

    Goteborg, 413 45
    Sweden

    Active - Recruiting

  • Skanes universitetssjukhus

    Lund, 222 42
    Sweden

    Active - Recruiting

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76
    Sweden

    Active - Recruiting

  • Sodersjukhuset

    Stockholm, 118 83
    Sweden

    Active - Recruiting

  • Uppsala University

    Uppsala, SE 751 85
    Sweden

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 83301
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung, 80756
    Taiwan

    Active - Recruiting

  • Chang Kung Memorial Hospital

    Kaohsiung City, 833
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10043
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Adana City Hospital

    Adana, 01060
    Turkey

    Active - Recruiting

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200
    Turkey

    Active - Recruiting

  • Gazi University Hospital

    Ankara, 06560
    Turkey

    Active - Recruiting

  • Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010
    Turkey

    Active - Recruiting

  • Bakirkoy Training and Research Hospital

    Istanbul, 34147
    Turkey

    Active - Recruiting

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42090
    Turkey

    Active - Recruiting

  • Sakarya University Training and Research Hospital

    Sakarya, 54290
    Turkey

    Active - Recruiting

  • Marmara University Pendik Training Hospital

    İstanbul, 34899
    Turkey

    Active - Recruiting

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU
    United Kingdom

    Active - Recruiting

  • Castle Hill Hospital

    Hull, HU16 5JQ
    United Kingdom

    Active - Recruiting

  • St James University Hospital

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • St Bartholomew's Hospital

    London, EC1A 7BE
    United Kingdom

    Active - Recruiting

  • University College Hospital

    London, NW1 2BU
    United Kingdom

    Active - Recruiting

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital (Sutton)

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

  • St. Bernard's Medical Center

    Jonesboro, Arkansas 72401
    United States

    Active - Recruiting

  • CBCC Global Research

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Providence Medical Foundation

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Torrance Memorial Physicians Network

    Torrance, California 90505
    United States

    Active - Recruiting

  • Yale University School Of Medicine

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Georgetown Univ Medical Center Lombardi Cancer Center

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Winship Cancer Institute Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Fort Wayne Medical Oncology & Hematology

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • MedStar Franklin Square Medical Center

    Baltimore, Maryland 21237
    United States

    Active - Recruiting

  • Hattiesburg Clinic

    Hattiesburg, Mississippi 39401
    United States

    Active - Recruiting

  • Washington University School Of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Nebraska Cancer Specialists Midwest Cancer Center

    Omaha, Nebraska 68130
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Active - Recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey 08816
    United States

    Active - Recruiting

  • Rutgers Cancer Institute

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87102
    United States

    Active - Recruiting

  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Mount Sinai

    New York, New York 10003
    United States

    Active - Recruiting

  • New York Cancer and Blood Specialists

    Shirley, New York 11967
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27516
    United States

    Active - Recruiting

  • Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion

    Cleveland, Ohio 44111
    United States

    Active - Recruiting

  • Taussig Cancer Insititute Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Cleveland Clinic Cancer Center Independence Family Health Center

    Independence, Ohio 44131
    United States

    Active - Recruiting

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio 44906
    United States

    Active - Recruiting

  • Cleveland Clinic Cancer Center Hillcrest Hospital

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

  • Cleveland Clinic Cancer Centers Sandusky

    Sandusky, Ohio 44870
    United States

    Active - Recruiting

  • Cleveland Clinic Cancer Center Strongsville

    Strongsville, Ohio 44136
    United States

    Active - Recruiting

  • Cleveland Clinic Cancer Center South Pointe Hospital

    Warrensville Heights, Ohio 44122
    United States

    Active - Recruiting

  • Wooster Milltown Specialty and Surgery Center

    Wooster, Ohio 44691
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Baylor Scott and White Health

    Temple, Texas 76508
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Edmonds, Washington 98026
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Issaquah, Washington 98029
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Active - Recruiting

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