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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT06662786

Registry updated: 2026-09-25
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Description

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.

Interventions

  • Amivantamab (Biological)
    Amivantamab will be administered.
  • Cetuximab (Biological)
    Cetuximab will be administered.
  • 5-fluorouracil (Drug)
    5-fluorouracil will be administered as chemotherapy regimen.
  • Leucovorin calcium/Levoleucovorin (Drug)
    Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
  • Oxaliplatin (Drug)
    Oxaliplatin will be administered as chemotherapy regimen.
  • Irinotecan Hydrochloride (Drug)
    Irinotecan hydrochloride will be administered as chemotherapy regimen.

Eligibility criteria

Inclusion Criteria: * Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease * Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available) * Must agree to the submission of fresh tumor tissue * Have measurable disease according to RECIST v1.1 * Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (\>) 12 months prior to CRC recurrence/metastases * Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1 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 imaging at screening * Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI * Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s) * Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (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), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)

Conditions

Colorectal Neoplasms

Locations

  • Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
  • St. Bernard's Medical Center — Jonesboro, Arkansas, United States
  • Highlands Oncology Group — Springdale, Arkansas, United States
  • CBCC Global Research — Bakersfield, California, United States
  • Los Angeles Cancer Network — Glendale, California, United States
  • Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
  • USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
  • UCLA — Santa Monica, California, United States
  • Providence Medical Foundation — Santa Rosa, California, United States
  • Torrance Memorial Physicians Network — Torrance, California, United States
  • Rocky Mountain Cancer Centers — Denver, Colorado, United States
  • Yale University School Of Medicine — New Haven, Connecticut, United States
  • Georgetown Univ Medical Center Lombardi Cancer Center — Washington D.C., District of Columbia, United States
  • Florida Cancer Specialists South — Fort Myers, Florida, United States
  • AdventHealth Medical Group Oncology and Hematology at Orlando — Orlando, Florida, United States
  • Florida Cancer Specialists North Region — St. Petersburg, Florida, United States
  • Florida Cancer Specialists East — West Palm Beach, Florida, United States
  • Grady Memorial Hospital — Atlanta, Georgia, United States
  • Winship Cancer Institute Emory University — Atlanta, Georgia, United States
  • Illinois Cancer Specialists — Arlington Heights, Illinois, United States
  • Illinois CancerCare — Peoria, Illinois, United States
  • Fort Wayne Medical Oncology & Hematology — Fort Wayne, Indiana, United States
  • University of Iowa Hospital — Iowa City, Iowa, United States
  • Mission Cancer Blood — Waukee, Iowa, United States
  • Cancer Center of Kansas — Wichita, Kansas, United States
  • Ochsner Clinic Foundation — New Orleans, Louisiana, United States
  • MedStar Franklin Square Medical Center — Baltimore, Maryland, United States
  • Frederick Health Hospital - James M Stockman Cancer Institute — Frederick, Maryland, United States
  • VA Ann Arbor Healthcare System — Ann Arbor, Michigan, United States
  • University of Michigan — Ann Arbor, Michigan, United States
  • Henry Ford Hospital — Detroit, Michigan, United States
  • Start Midwest — Grand Rapids, Michigan, United States
  • Hattiesburg Clinic — Hattiesburg, Mississippi, United States
  • Washington University School Of Medicine — St Louis, Missouri, United States
  • Nebraska Cancer Specialists Midwest Cancer Center — Omaha, Nebraska, United States
  • Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
  • Astera Cancer Care — East Brunswick, New Jersey, United States
  • Rutgers Cancer Institute — New Brunswick, New Jersey, United States
  • University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
  • Perlmutter Cancer Center at NYU Long Island — Mineola, New York, United States
  • Mount Sinai — New York, New York, United States
  • Mount Sinai West — New York, New York, United States
  • NYU Langone Medical Center NYU Hematology Associates — New York, New York, United States
  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center — New York, New York, United States
  • New York Cancer and Blood Specialists — Shirley, New York, United States
  • Montefiore Einstein Comprehensive Cancer Center — The Bronx, New York, United States
  • University of Buffalo Kaleida Health Cancer Care — Williamsville, New York, United States
  • University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
  • Gabrail Cancer Center — Canton, Ohio, United States
  • University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
  • Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion — Cleveland, Ohio, United States
  • Taussig Cancer Insititute Cleveland Clinic — Cleveland, Ohio, United States
  • Cleveland Clinic Cancer Center Independence Family Health Center — Independence, Ohio, United States
  • Cleveland Clinic Cancer Center Mansfield — Mansfield, Ohio, United States
  • Cleveland Clinic Cancer Center Hillcrest Hospital — Mayfield Heights, Ohio, United States
  • Cleveland Clinic Cancer Centers Sandusky — Sandusky, Ohio, United States
  • Cleveland Clinic Cancer Center Strongsville — Strongsville, Ohio, United States
  • Cleveland Clinic Cancer Center South Pointe Hospital — Warrensville Heights, Ohio, United States
  • Wooster Milltown Specialty and Surgery Center — Wooster, Ohio, United States
  • St Charles Medical Center — Bend, Oregon, United States
  • Oregon Health And Science University — Portland, Oregon, United States
  • Thomas Jefferson University — Philadelphia, Pennsylvania, United States
  • Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • SCRI Oncology Partners — Nashville, Tennessee, United States
  • Texas Oncology West Texas — Abilene, Texas, United States
  • Texas Oncology DFW — Dallas, Texas, United States
  • UT Southwestern — Dallas, Texas, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • Baylor Scott and White Health 1 — Round Rock, Texas, United States
  • Texas Oncology - San Antonio — San Antonio, Texas, United States
  • Baylor Scott and White Health — Temple, Texas, United States
  • Virginia Cancer Specialists — Arlington, Virginia, United States
  • Inova Schar Cancer Institute Dept of Fairfax Hospital — Fairfax, Virginia, United States
  • Richmond VA Medical Center — Richmond, Virginia, United States
  • VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
  • Swedish Cancer Institute Edmonds — Edmonds, Washington, United States
  • Swedish Cancer Institute Issaquah — Issaquah, Washington, United States
  • Swedish Cancer Institute — Seattle, Washington, United States
  • Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
  • William S. Middleton Memorial VA — Madison, Wisconsin, United States
  • Institut Jules Bordet — Anderlecht, Belgium
  • Universitair Ziekenhuis Antwerpen — Edegem, Belgium
  • AZ Maria Middelares — Ghent, Belgium
  • Hopital de Jolimont — Haine Saint Paul La Louviere, Belgium
  • Az Groeninge — Kortrijk, Belgium
  • Universitair Ziekenhuis Leuven — Leuven, Belgium
  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman — Liège, Belgium
  • Fundacao Pio XII — Barretos, Brazil
  • Fundacao Universidade de Caxias do Sul — Caxias do Sul, Brazil
  • Fundacao Doutor Amaral Carvalho — Jaú, Brazil
  • Hospital Nossa Senhora da Conceicao S A — Porto Alegre, Brazil
  • Hospital Santa Izabel Santa Casa de Misericordia da Bahia — Salvador, Brazil
  • Clinica de Hematologia e Oncologia Viver Ltda — Santa Maria, Brazil
  • Funfarme Sjrp — São José do Rio Preto, Brazil
  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo — São Paulo, Brazil
  • Fundacao Antonio Prudente A C Camargo Cancer Center — São Paulo, Brazil
  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo, Brazil
  • Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia — Vitória, Brazil
  • Arthur J E Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
  • Ottawa Hospital — Ottawa, Ontario, Canada
  • Princess Margaret Cancer Centre — Toronto, Ontario, Canada
  • Centre de Recherche du CHUM — Montreal, Quebec, Canada
  • Peking University First Hospital — Beijing, China
  • Beijing Friendship Hospital Capital Medical University — Beijing, China
  • Beijing Cancer Hospital — Beijing, China
  • Peking University Third Hospital — Beijing, China
  • The First Bethune Hospital of Jilin University — Changchun, China
  • Hunan Cancer hospital — Changsha, China
  • Sun Yat Sen University Cancer Center — Guangzhou, China
  • The Sixth Affiliated Hospital Sun Yat sen University — Guangzhou, China
  • Guangdong Provincial People's Hospital — Guangzhou, China
  • The First Affiliated Hospital Zhejiang University College of Medicine — Hangzhou, China
  • The Second Affiliated Hospital of Zhejiang University College of Medicine — Hangzhou, China
  • Zhejiang Cancer Hospital — Hangzhou, China
  • Harbin medical university cancer hospital — Harbin, China
  • Huizhou Central People's Hospital — Huizhou, China
  • The First Affiliated Hospital of NanChang University — Nanchang, China
  • Fudan University Shanghai Cancer Center — Shanghai, China
  • Liaoning Cancer Hospital and Institute — Shenyang, China
  • Peking University Shenzhen Hospital — Shenzhen, China
  • West China Hospital of Sichuan University — Sichuan, China
  • First Hospital of Shanxi Medical University — Taiyuan, China
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin, China
  • Hubei Cancer Hospital — Wuhan, China
  • Institut Sainte Catherine — Avignon, France
  • Hopital Claude Huriez — Lille, France
  • Hopital Prive Jean Mermoz — Lyon, France
  • Institut du Cancer de Montpellier — Montpellier, France
  • CHU Nantes — Nantes, France
  • Hopital Saint Antoine — Paris, France
  • Hopital Haut Leveque — Pessac, France
  • CHU De Poitiers — Poitiers, France
  • Gustave Roussy — Villejuif, France
  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum — Berlin, Germany
  • Universitaetsklinikum Carl Gustav Carus TU Dresden — Dresden, Germany
  • Essen University Hospital — Essen, Germany
  • Krankenhaus NorthWest — Frankfurt am Main, Germany
  • Praxis fur interdisziplinare Onkologie & Hamatologie GbR — Freiburg im Breisgau, Germany
  • Asklepios Klinik Altona — Hamburg, Germany
  • National Center for Tumor Diseases NCT — Heidelberg, Germany
  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz — Mainz, Germany
  • Klinikum der Universitaet Muenchen — Munich, Germany
  • Universitatsklinikum Ulm — Ulm, Germany
  • Semmelweis Egyetem — Budapest, Hungary
  • Markhot Ferenc Oktatokorhaz es Rendelointezet — Eger, Hungary
  • Pecsi Tudomanyegyetem — Pécs, Hungary
  • Szegedi Tudomanyegyetem — Szeged, Hungary
  • Rajiv Gandhi Cancer Institute and Research Centre — Delhi, India
  • B P Poddar Hospital and Medical research Limited — Kolkata, India
  • Tata Memorial Hospital — Mumbai, India
  • Deenanath Mangeshkar Hospital and Research Centre — Pune, India
  • Mahamana Pandit Madan Mohan Malviya Cancer Centre — Varanasi, India
  • Yitzhak Shamir Medical Center — Beer Yaakov, Israel
  • Rambam Medical Center — Haifa, Israel
  • Hadassah University Hospita Ein Kerem — Jerusalem, Israel
  • Rabin Medical Center — Petah Tikva, Israel
  • Sheba Medical Center — Ramat Gan, Israel
  • Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
  • Assuta MC — Tel Aviv, Israel
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori — Meldola, Italy
  • Istituto Dei Tumori Di Milano — Milan, Italy
  • Istituto Oncologico Veneto - IRCCS — Padova, Italy
  • Azienda Ospedaliero Universitaria Pisana — Pisa, Italy
  • Istituto Clinico Humanitas — Rozzano, Italy
  • Chiba Cancer Center — Chiba, Japan
  • National Cancer Center Hospital — Chūōku, Japan
  • National Cancer Center Hospital East — Kashiwa, Japan
  • Aichi Cancer Center — Nagoya, Japan
  • National Hospital Organization Osaka National Hospital — Osaka, Japan
  • Osaka International Cancer Institute — Osaka, Japan
  • Shizuoka Cancer Center — Shizuoka, Japan
  • The University of Osaka Hospital — Suita, Japan
  • The Cancer Institute Hospital of JFCR — Tokyo, Japan
  • Hospital Canselor Tuanku Muhriz UKM — Cheras, Malaysia
  • Hospital Pulau Pinang — George Town, Malaysia
  • Hospital Raja Permaisuri Bainun — Ipoh, Malaysia
  • Hospital Kuala Lumpur — Kuala Lumpur, Malaysia
  • University Malaya Medical Centre — Kuala Lumpur, Malaysia
  • Hospital Umum Sarawak — Kuching, Malaysia
  • National Cancer Institute — Putrajaya, Malaysia
  • Meander Medisch Centrum — Amersfoort, Netherlands
  • Antoni van Leeuwenhoek — Amsterdam, Netherlands
  • Radboud University Medical Center — Nijmegen, Netherlands
  • Erasmus MC — Rotterdam, Netherlands
  • Elisabeth-TweeSteden Ziekenhuis — Tilburg, Netherlands
  • UMC Utrecht — Utrecht, Netherlands
  • Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku — Bialystok, Poland
  • Wojewodzki Szpital Specjalistyczny — Biała Podlaska, Poland
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza — Brzozów, Poland
  • Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach — Gliwice, Poland
  • Instytut Centrum Zdrowia Matki Polki — Lodz, Poland
  • Szpital Kliniczny MSWiA z WMCO — Olsztyn, Poland
  • SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego — Opole, Poland
  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy — Warsaw, Poland
  • Pan American Center for Oncology Trials LLC — Barrio Monacillos, Puerto Rico
  • Kyungpook National University Chilgok Hospital — Daegu, South Korea
  • 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
  • The Catholic University of Korea Seoul St Marys Hospital — Seoul, South Korea
  • Hosp Univ Vall D Hebron — Barcelona, Spain
  • Hosp. de La Santa Creu I Sant Pau — Barcelona, Spain
  • Hosp. Gral. Univ. Gregorio Maranon — Madrid, Spain
  • Hosp. Univ. Ramon Y Cajal — Madrid, Spain
  • Hosp. Univ. 12 de Octubre — Madrid, Spain
  • Clinica Univ. de Navarra — Pamplona, Spain
  • Hosp. Virgen Del Rocio — Seville, Spain
  • Hosp. Clinico Univ. de Valencia — Valencia, Spain
  • Sahlgrenska University Hospital — Gothenburg, Sweden
  • Skanes universitetssjukhus — Lund, Sweden
  • Sodersjukhuset — Stockholm, Sweden
  • Karolinska Universitetssjukhuset — Stockholm, Sweden
  • Uppsala University — Uppsala, Sweden
  • Kaohsiung Medical University Chung Ho Memorial Hospital — Kaohsiung City, Taiwan
  • Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan
  • Adana City Hospital — Adana, Turkey (Türkiye)
  • Gulhane Egitim ve Arastirma Hastanesi — Ankara, Turkey (Türkiye)
  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital — Ankara, Turkey (Türkiye)
  • Gazi Universitesi Hastanesi — Ankara, Turkey (Türkiye)
  • Ankara Bilkent Sehir Hastanesi — Ankara, Turkey (Türkiye)
  • Bakirkoy Training and Research Hospital — Istanbul, Turkey (Türkiye)
  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi — Istanbul, Turkey (Türkiye)
  • Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi — Konya, Turkey (Türkiye)
  • Sakarya University Training and Research Hospital — Sakarya, Turkey (Türkiye)
  • Birmingham Heartlands Hospital — Birmingham, United Kingdom
  • Addenbrooke's Hospital — Cambridge, United Kingdom
  • Western General Hospital — Edinburgh, United Kingdom
  • Castle Hill Hospital — Hull, United Kingdom
  • St James University Hospital — Leeds, United Kingdom
  • St Bartholomew's Hospital — London, United Kingdom
  • University College Hospital — London, United Kingdom
  • Mount Vernon Cancer Centre — Northwood, United Kingdom
  • Royal Marsden Hospital (Sutton) — Sutton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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