RECRUITING Phase 3 ClinicalTrials.gov

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT06750094

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) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.

Interventions

Amivantamab (Biological)
Amivantamab will be administered.
Cetuximab (Biological)
Cetuximab will be administered.
Bevacizumab (Biological)
Bevacizumab 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.
Irinotecan (Drug)
Irinotecan will be administered as chemotherapy regimen.

Eligibility criteria

Inclusion Criteria: * Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease * Determined to have kirsten rat sarcoma viral oncogene/neuroblastoma RAS viral oncogene homolog (KRAS/NRAS), G12, G13 and v-raf murine sarcoma viral oncogene homolog B (BRAF) V600X (X represents any single amino acid change from the original amino acid) wild type status by local and/or central next-generation sequencing (NGS) testing * Must agree to the submission of fresh or archival tumor tissue post progression from the most recent therapy, if clinically feasible * Have measurable disease according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 * Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1 * Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy. Participants can receive anti-VEGF as prior line of therapy 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: amivantamab, cetuximab or bevacizumab or 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 who has not received immunotherapy treatments * Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor * Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)

Conditions

Colorectal Neoplasms

Locations

Ironwood Cancer and Research Center — Chandler, Arizona, United States
Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
Arizona Oncology Associates PC NAHOA — Prescott, 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
University of Colorado Denver Anschultz Medical Campus — Aurora, Colorado, United States
Rocky Mountain Cancer Centers — Denver, Colorado, United States
Eastern Connecticut Hematology & Oncology Assoc. — Norwich, Connecticut, United States
Florida Cancer Specialists South — Fort Myers, Florida, United States
Mount Sinai Medical Center Campus — Miami Beach, Florida, United States
AdventHealth Cancer Institute — Orlando, Florida, United States
Florida Cancer Specialists North Region — St. Petersburg, Florida, United States
Florida Cancer Specialists East — West Palm Beach, Florida, United States
University Cancer And Blood Center LLC — Athens, Georgia, United States
Grady Memorial Hospital — Atlanta, Georgia, United States
Piedmont Cancer Institute — 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
Franciscan Health — Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
Mission Cancer Blood — Waukee, Iowa, United States
Cancer Center of Kansas — Wichita, Kansas, United States
Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States
MedStar Franklin Square Medical Center — Baltimore, Maryland, United States
Frederick Health Hospital - James M Stockman Cancer Institute — Frederick, Maryland, United States
University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States
Henry Ford Hospital — Detroit, Michigan, United States
Cancer And Hematology Centers of Western Michigan PC — Grand Rapids, Michigan, United States
Hattiesburg Clinic — Hattiesburg, Mississippi, United States
Washington University School Of Medicine — St Louis, Missouri, United States
Nebraska Cancer Specialists — Omaha, Nebraska, United States
Astera Cancer Care — East Brunswick, New Jersey, United States
Perlmutter Cancer Center at NYU Long Island — Mineola, New York, United States
NYU Langone Medical Center NYU Hematology Associates — 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
Gabrail Cancer Center — Canton, Ohio, United States
University Hospital of Cleveland — Cleveland, Ohio, United States
Oregon Health And Science University — Portland, Oregon, United States
Alliance Cancer Specialists at Main Line — Penn Wynne, Pennsylvania, 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
Tennessee Oncology Chattanooga — Chattanooga, Tennessee, United States
SCRI Oncology Partners — Nashville, Tennessee, United States
Tennessee Oncology — Nashville, Tennessee, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
Texas Oncology West Texas — Abilene, Texas, United States
Parkland Health and Hospital System — Dallas, Texas, United States
Texas Oncology DFW — Dallas, Texas, United States
UT Southwestern Medical Center — Dallas, Texas, United States
MD Anderson Cancer Center — Houston, Texas, United States
Baylor Scott & White Medical Center — Round Rock, Texas, United States
Texas Oncology - San Antonio — San Antonio, Texas, United States
Scott And White Memorial Hospital — Temple, Texas, United States
UT Health East Texas HOPE Cancer Center — Tyler, Texas, United States
Virginia Cancer Specialists — Arlington, Virginia, United States
Richmond VA Medical Center — Richmond, Virginia, United States
VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
Providence Regional Cancer System — Lacey, Washington, United States
Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
Medical College Of Wisconsin — Milwaukee, Wisconsin, United States
Concord Hospital — Concord, Australia
Warringal Private Hospital — Heidelberg, Australia
Queen Elizabeth Hospital — South Woodville, Australia
Western Health Sunshine Hospital — St Albans, Australia
Institut Jules Bordet — Anderlecht, Belgium
UZ Antwerpen — Edegem, Belgium
AZ Maria Middelares — Ghent, Belgium
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
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
Peking University First Hospital — Beijing, China
Beijing Friendship Hospital Capital Medical University — Beijing, China
Beijing Cancer Hospital — Beijing, China
The First Bethune Hospital of Jilin University — Changchun, China
Hunan Cancer hospital — Changsha, China
West China Hospital of Sichuan University — Chengdu, China
Ganzhou Cancer Hospital — Ganzhou, 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 Second Affiliated Hospital of Zhejiang University — Hangzhou, China
Zhejiang Cancer Hospital — Hangzhou, China
Harbin medical university cancer hospital — Harbin, China
Huizhou Central People's Hospital — Huizhou, China
Gansu Provincial Cancer Hospital — Lanzhou, China
The First Affiliated Hospital of NanChang University — Nanchang, China
Fudan University Shanghai Cancer Center — Shanghai, China
Liaoning Cancer Hospital and Institute — Shenyang, China
Tianjin Medical University Cancer Institute and Hospital — Tianjin, China
Hubei Cancer Hospital — Wuhan, China
Institut Sainte Catherine — Avignon, France
Hopital Haut Leveque — Pessac, France
CHU De Poitiers — Poitiers, France
Charite Universitatsmedizin Berlin Campus Virchow Klinikum — Berlin, Germany
Krankenhaus NorthWest — Frankfurt am Main, Germany
National Center for Tumor Diseases NCT — Heidelberg, Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz — Mainz, Germany
Klinikum der Universitaet Muenchen — Munich, Germany
Queen Mary Hospital — Hong Kong, Hong Kong
Prince Of Wales Hospital — Shatin, Hong Kong
Markhot Ferenc Oktatokorhaz es Rendelointezet — Eger, Hungary
Pecsi Tudomanyegyetem — Pécs, Hungary
Szegedi Tudomanyegyetem — Szeged, Hungary
Rajiv Gandhi Cancer Institute and Research Centre — Delhi, India
Asian Institute Of Gastroenterology — Hyderabad, India
B P Poddar Hospital and Medical research Limited — Kolkata, India
Tata Memorial Hospital — Mumbai, India
Safdarjung Hospital — New Delhi, India
Deenanath Mangeshkar Hospital and Research Centre — Pune, India
Mahamana Pandit Madan Mohan Malviya Cancer Centre — Varanasi, India
Christian medical — Vellore, India
Yitzhak Shamir Medical Center — Beer Yaakov, Israel
Rambam Medical Center — Haifa, Israel
Hadassah Medical Center — 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
Fondazione del Piemonte per I Oncologia IRCC Candiolo — Candiolo, Italy
ARNAS Garibaldi P O Nesima — Catania, Italy
Careggi University Hospital — Florence, 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
Azienda Sanitaria Universitaria Friuli Centrale ASU FC — Udine, 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
Kindai University Hospital — Sakai, Japan
Shizuoka Cancer Center — Shizuoka, Japan
The University of Osaka Hospital — Suita, Japan
The Cancer Institute Hospital of JFCR — Tokyo, Japan
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
Institut Kanser Negara Clinical Research Center — Putrajaya, Malaysia
Centro Oncologico de Chihuahua — Chihuahua City, Mexico
Actualidad Basada En La Investigacion Del Cancer — Guadalajara, Mexico
Centro Oncologico Personalizado Cope S De R L De C V — Mexico City, Mexico
Instituto Nacional de Cancerologia — Mexico City, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez — Monterrey, Mexico
Oncocenter — Puebla City, Mexico
Cuidados Oncologicos — Querétaro, Mexico
Health Pharma Queretaro SA de CV — Querétaro, Mexico
COI Centro Oncologico Internacional Tijuana — Tijuana, Mexico
Meander Medisch Centrum — Amersfoort, Netherlands
Antoni van Leeuwenhoek — Amsterdam, Netherlands
Radboud University Medical Center — Nijmegen, Netherlands
Erasmus MC — Rotterdam, Netherlands
ETZ TweeSteden — Tilburg, 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 — San Juan, Puerto Rico
Centrul Medical Unirea SRL — Brasov, Romania
Spitalul Memorial Baneasa — Bucharest, Romania
Ponderas Academic Hospital — Bucharest, Romania
Neolife Medical Center Bucharest — Bucharest, Romania
Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca — Cluj-Napoca, Romania
Clinica de Oncologie Sf Nectarie — Craiova, Romania
Institutul Regional de Oncologie Iasi — Iași, Romania
Pelican Impex SRL — Oradea, Romania
Kyungpook National University Chilgok Hospital — Daegu, South Korea
Korea University Anam Hospital — Seoul, 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 Mary s Hospital — Seoul, South Korea
Hosp. Univ. de Badajoz — Badajoz, Spain
Hosp. Del Mar — Barcelona, Spain
Hosp. Univ. Quiron Dexeus — Barcelona, Spain
Hosp Univ Vall D Hebron — Barcelona, Spain
Hosp. de La Santa Creu I Sant Pau — Barcelona, Spain
Hosp San Francisco de Asis — Madrid, Spain
Hosp. Gral. Univ. Gregorio Maranon — Madrid, Spain
Hosp. Univ. Ramon Y Cajal — Madrid, Spain
Hosp Univ Fund Jimenez Diaz — Madrid, Spain
Hosp. Univ. 12 de Octubre — Madrid, Spain
Hosp Regional Univ de Malaga — Málaga, Spain
Clinica Univ. de Navarra — Pamplona, Spain
Hosp. Virgen Del Rocio — Seville, Spain
Hosp. Clinico Univ. de Valencia — Valencia, Spain
Sahlgrenska Universitetssjukhuset — 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
Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
Taichung Veterans General Hospital — Taichung, 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 — Taoyuan, Taiwan
Ramathibodi Hospital — Bangkok, Thailand
Siriraj Hospital — Bangkok, Thailand
Chiang Mai University — Chiang Mai, Thailand
Songklanagarind hospital — Songkhla, Thailand
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)
Memorial Antalya Hospital — Antalya, Turkey (Türkiye)
Trakya University Medical Faculty — Edirne, 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
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
Royal Marsden Hospital — London, United Kingdom
Mount Vernon Cancer Centre — Northwood, United Kingdom

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