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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
NCT06662786 · Janssen Research & Development, LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Randomized, Open-label Phase 3 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
About this study
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 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)
Study design
Enrollment target: 1000 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-10-18
Estimated completion: 2032-01-30
Last updated: 2026-04-13
Interventions
Biological: AmivantamabBiological: CetuximabDrug: 5-fluorouracilDrug: Leucovorin calcium/LevoleucovorinDrug: OxaliplatinDrug: Irinotecan Hydrochloride
Primary outcomes
- • Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) (Up to 4 years and 2 months)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (234)
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
St. Bernard's Medical CenterRecruiting
Jonesboro, Arkansas, United States
Highlands Oncology GroupRecruiting
Springdale, Arkansas, United States
CBCC Global ResearchRecruiting
Bakersfield, California, United States
Los Angeles Cancer NetworkRecruiting
Glendale, California, United States
Cancer and Blood Specialty ClinicRecruiting
Los Alamitos, California, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
UCLARecruiting
Santa Monica, California, United States
Providence Medical FoundationRecruiting
Santa Rosa, California, United States
Torrance Memorial Physicians NetworkRecruiting
Torrance, California, United States
Rocky Mountain Cancer CentersRecruiting
Denver, Colorado, United States
Yale University School Of MedicineRecruiting
New Haven, Connecticut, United States
Georgetown Univ Medical Center Lombardi Cancer CenterRecruiting
Washington D.C., District of Columbia, United States
Florida Cancer Specialists SouthRecruiting
Fort Myers, Florida, United States
AdventHealth Medical Group Oncology and Hematology at OrlandoRecruiting
Orlando, Florida, United States
Florida Cancer Specialists North RegionRecruiting
St. Petersburg, Florida, United States
Florida Cancer Specialists EastRecruiting
West Palm Beach, Florida, United States
Grady Memorial HospitalRecruiting
Atlanta, Georgia, United States
Winship Cancer Institute Emory UniversityRecruiting
Atlanta, Georgia, United States
Illinois CancerCareRecruiting
Peoria, Illinois, United States
Fort Wayne Medical Oncology & HematologyRecruiting
Fort Wayne, Indiana, United States
University of Iowa HospitalRecruiting
Iowa City, Iowa, United States
Mission Cancer BloodRecruiting
Waukee, Iowa, United States
Cancer Center of KansasRecruiting
Wichita, Kansas, United States
Ochsner Clinic FoundationRecruiting
New Orleans, Louisiana, United States
MedStar Franklin Square Medical CenterRecruiting
Baltimore, Maryland, United States
VA Ann Arbor Healthcare SystemRecruiting
Ann Arbor, Michigan, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Henry Ford HospitalRecruiting
Detroit, Michigan, United States
Start MidwestRecruiting
Grand Rapids, Michigan, United States
Hattiesburg ClinicRecruiting
Hattiesburg, Mississippi, United States
Washington University School Of MedicineRecruiting
St Louis, Missouri, United States
Nebraska Cancer Specialists Midwest Cancer CenterRecruiting
Omaha, Nebraska, United States
Comprehensive Cancer Centers of NevadaRecruiting
Las Vegas, Nevada, United States
Astera Cancer CareRecruiting
East Brunswick, New Jersey, United States
Rutgers Cancer InstituteRecruiting
New Brunswick, New Jersey, United States
University of New Mexico Cancer CenterRecruiting
Albuquerque, New Mexico, United States
Perlmutter Cancer Center at NYU Long IslandRecruiting
Mineola, New York, United States
Mount SinaiRecruiting
New York, New York, United States
Mount Sinai WestRecruiting
New York, New York, United States
NYU Langone Medical Center NYU Hematology AssociatesRecruiting
New York, New York, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterRecruiting
New York, New York, United States
New York Cancer and Blood SpecialistsRecruiting
Shirley, New York, United States
Montefiore Einstein Comprehensive Cancer CenterRecruiting
The Bronx, New York, United States
University of North Carolina at Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Gabrail Cancer CenterRecruiting
Canton, Ohio, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center Fairview Hospital Moll PavilionRecruiting
Cleveland, Ohio, United States
Taussig Cancer Insititute Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center Independence Family Health CenterRecruiting
Independence, Ohio, United States
Cleveland Clinic Cancer Center MansfieldRecruiting
Mansfield, Ohio, United States
Cleveland Clinic Cancer Center Hillcrest HospitalRecruiting
Mayfield Heights, Ohio, United States
Cleveland Clinic Cancer Centers SanduskyRecruiting
Sandusky, Ohio, United States
Cleveland Clinic Cancer Center StrongsvilleRecruiting
Strongsville, Ohio, United States
Cleveland Clinic Cancer Center South Pointe HospitalRecruiting
Warrensville Heights, Ohio, United States
Wooster Milltown Specialty and Surgery CenterRecruiting
Wooster, Ohio, United States
Oregon Health And Science UniversityRecruiting
Portland, Oregon, United States
Thomas Jefferson UniversityRecruiting
Philadelphia, Pennsylvania, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
University Of Pittsburgh Medical Center UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology West TexasRecruiting
Abilene, Texas, United States
Texas Oncology DFWRecruiting
Dallas, Texas, United States
UT SouthwesternRecruiting
Dallas, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Texas Oncology - San AntonioRecruiting
San Antonio, Texas, United States
Baylor Scott and White HealthRecruiting
Temple, Texas, United States
Virginia Cancer SpecialistsRecruiting
Arlington, Virginia, United States
Inova Schar Cancer Institute Dept of Fairfax HospitalRecruiting
Fairfax, Virginia, United States
Richmond VA Medical CenterRecruiting
Richmond, Virginia, United States
VCU Massey Comprehensive Cancer CenterRecruiting
Richmond, Virginia, United States
Swedish Cancer Institute EdmondsRecruiting
Edmonds, Washington, United States
Swedish Cancer Institute IssaquahRecruiting
Issaquah, Washington, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
Fred Hutchinson Cancer Research CenterRecruiting
Seattle, Washington, United States
William S. Middleton Memorial VARecruiting
Madison, Wisconsin, United States
Institut Jules BordetRecruiting
Anderlecht, Belgium
Universitair Ziekenhuis AntwerpenRecruiting
Edegem, Belgium
AZ Maria MiddelaresRecruiting
Ghent, Belgium
Hopital de JolimontRecruiting
Haine Saint Paul La Louviere, Belgium
Az GroeningeRecruiting
Kortrijk, Belgium
Universitair Ziekenhuis LeuvenRecruiting
Leuven, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart TilmanRecruiting
Liège, Belgium
Fundacao Pio XIIRecruiting
Barretos, Brazil
Fundacao Universidade de Caxias do SulRecruiting
Caxias do Sul, Brazil
Fundacao Doutor Amaral CarvalhoRecruiting
Jaú, Brazil
Hospital Nossa Senhora da Conceicao S ARecruiting
Porto Alegre, Brazil
Hospital Santa Izabel Santa Casa de Misericordia da BahiaRecruiting
Salvador, Brazil
Clinica de Hematologia e Oncologia Viver LtdaRecruiting
Santa Maria, Brazil
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De BaseRecruiting
São José do Rio Preto, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao PauloRecruiting
São Paulo, Brazil
Fundacao Antonio Prudente A C Camargo Cancer CenterRecruiting
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting
São Paulo, Brazil
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de CassiaRecruiting
Vitória, Brazil
Arthur J E Child Comprehensive Cancer CentreRecruiting
Calgary, Alberta, Canada
Ottawa HospitalRecruiting
Ottawa, Ontario, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Centre de Recherche du CHUMRecruiting
Montreal, Quebec, Canada
Peking University First HospitalRecruiting
Beijing, China
Beijing Friendship Hospital Capital Medical UniversityRecruiting
Beijing, China
Beijing Cancer HospitalRecruiting
Beijing, China
Peking University Third HospitalRecruiting
Beijing, China
The First Bethune Hospital of Jilin UniversityRecruiting
Changchun, China
Hunan Cancer hospitalRecruiting
Changsha, China
Sun Yat Sen University Cancer CenterRecruiting
Guangzhou, China
The Sixth Affiliated Hospital Sun Yat sen UniversityRecruiting
Guangzhou, China
Guangdong Provincial People's HospitalRecruiting
Guangzhou, China
The First Affiliated Hospital Zhejiang University College of MedicineRecruiting
Hangzhou, China
The Second Affiliated Hospital of Zhejiang University College of MedicineRecruiting
Hangzhou, China
Zhejiang Cancer HospitalRecruiting
Hangzhou, China
Harbin medical university cancer hospitalRecruiting
Harbin, China
Huizhou Central People's HospitalRecruiting
Huizhou, China
The First Affiliated Hospital of NanChang UniversityRecruiting
Nanchang, China
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, China
Liaoning Cancer Hospital and InstituteRecruiting
Shenyang, China
Peking University Shenzhen HospitalRecruiting
Shenzhen, China
West China Hospital of Sichuan UniversityRecruiting
Sichuan, China
First Hospital of Shanxi Medical UniversityRecruiting
Taiyuan, China
Tianjin Medical University Cancer Institute and HospitalRecruiting
Tianjin, China
Hubei Cancer HospitalRecruiting
Wuhan, China
Institut Sainte CatherineRecruiting
Avignon, France
Hopital Claude HuriezRecruiting
Lille, France
Hopital Prive Jean MermozRecruiting
Lyon, France
Institut du Cancer de MontpellierRecruiting
Montpellier, France
CHU NantesRecruiting
Nantes, France
Hopital Saint AntoineRecruiting
Paris, France
Hopital Haut LevequeRecruiting
Pessac, France
CHU De PoitiersRecruiting
Poitiers, France
Gustave RoussyRecruiting
Villejuif, France
Charite Universitatsmedizin Berlin Campus Virchow KlinikumRecruiting
Berlin, Germany
Universitaetsklinikum Carl Gustav Carus TU DresdenRecruiting
Dresden, Germany
Essen University HospitalRecruiting
Essen, Germany
Krankenhaus NorthWestRecruiting
Frankfurt am Main, Germany
Praxis fur interdisziplinare Onkologie & Hamatologie GbRRecruiting
Freiburg im Breisgau, Germany
Asklepios Klinik AltonaRecruiting
Hamburg, Germany
National Center for Tumor Diseases NCTRecruiting
Heidelberg, Germany
Universitatsmedizin der Johannes Gutenberg Universitat MainzRecruiting
Mainz, Germany
Klinikum der Universitaet MuenchenRecruiting
Munich, Germany
Universitatsklinikum UlmRecruiting
Ulm, Germany
Semmelweis EgyetemRecruiting
Budapest, Hungary
Markhot Ferenc Oktatokorhaz es RendelointezetRecruiting
Eger, Hungary
Pecsi TudomanyegyetemCompleted
Pécs, Hungary
Szegedi TudomanyegyetemRecruiting
Szeged, Hungary
Rajiv Gandhi Cancer Institute and Research CentreRecruiting
Delhi, India
B P Poddar Hospital and Medical research LimitedRecruiting
Kolkata, India
Tata Memorial HospitalRecruiting
Mumbai, India
Deenanath Mangeshkar Hospital and Research CentreRecruiting
Pune, India
Mahamana Pandit Madan Mohan Malviya Cancer CentreRecruiting
Varanasi, India
Yitzhak Shamir Medical CenterRecruiting
Beer Yaakov, Israel
Rambam Medical CenterRecruiting
Haifa, Israel
Hadassah University Hospita Ein KeremRecruiting
Jerusalem, Israel
Rabin Medical CenterRecruiting
Petah Tikva, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Assuta MCRecruiting
Tel Aviv, Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriRecruiting
Meldola, Italy
Istituto Dei Tumori Di MilanoRecruiting
Milan, Italy
Istituto Oncologico Veneto - IRCCSRecruiting
Padova, Italy
Azienda Ospedaliero Universitaria PisanaRecruiting
Pisa, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Italy
Chiba Cancer CenterRecruiting
Chiba, Japan
National Cancer Center HospitalRecruiting
Chūōku, Japan
National Cancer Center Hospital EastRecruiting
Kashiwa, Japan
Aichi Cancer CenterRecruiting
Nagoya, Japan
National Hospital Organization Osaka National HospitalRecruiting
Osaka, Japan
Osaka International Cancer InstituteRecruiting
Osaka, Japan
Shizuoka Cancer CenterRecruiting
Shizuoka, Japan
The University of Osaka HospitalRecruiting
Suita, Japan
The Cancer Institute Hospital of JFCRRecruiting
Tokyo, Japan
Hospital Canselor Tuanku Muhriz UKMRecruiting
Cheras, Malaysia
Hospital Pulau PinangRecruiting
George Town, Malaysia
Hospital Raja Permaisuri BainunRecruiting
Ipoh, Malaysia
Hospital Kuala LumpurRecruiting
Kuala Lumpur, Malaysia
University Malaya Medical CentreRecruiting
Kuala Lumpur, Malaysia
Hospital Umum SarawakRecruiting
Kuching, Malaysia
National Cancer InstituteRecruiting
Putrajaya, Malaysia
Meander Medisch CentrumRecruiting
Amersfoort, Netherlands
Antoni van LeeuwenhoekRecruiting
Amsterdam, Netherlands
Radboud University Medical CenterRecruiting
Nijmegen, Netherlands
Erasmus MCRecruiting
Rotterdam, Netherlands
Elisabeth-TweeSteden ZiekenhuisRecruiting
Tilburg, Netherlands
UMC UtrechtRecruiting
Utrecht, Netherlands
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w BialymstokuRecruiting
Bialystok, Poland
Wojewodzki Szpital SpecjalistycznyRecruiting
Biała Podlaska, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B MarkiewiczaRecruiting
Brzozów, Poland
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w GliwicachRecruiting
Gliwice, Poland
Instytut Centrum Zdrowia Matki PolkiRecruiting
Lodz, Poland
Szpital Kliniczny MSWiA z WMCORecruiting
Olsztyn, Poland
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza KoszarowskiegoRecruiting
Opole, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyRecruiting
Warsaw, Poland
Pan American Center for Oncology Trials LLCRecruiting
Barrio Monacillos, Puerto Rico
Kyungpook National University Chilgok HospitalRecruiting
Daegu, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
The Catholic University of Korea Seoul St Marys HospitalRecruiting
Seoul, South Korea
Hosp. de La Santa Creu I Sant PauRecruiting
Barcelona, Spain
Hosp Univ Vall D HebronRecruiting
Barcelona, Spain
Hosp. Gral. Univ. Gregorio MaranonRecruiting
Madrid, Spain
Hosp. Univ. Ramon Y CajalRecruiting
Madrid, Spain
Hosp. Univ. 12 de OctubreRecruiting
Madrid, Spain
Clinica Univ. de NavarraRecruiting
Pamplona, Spain
Hosp. Virgen Del RocioRecruiting
Seville, Spain
Hosp. Clinico Univ. de ValenciaRecruiting
Valencia, Spain
Sahlgrenska University HospitalRecruiting
Gothenburg, Sweden
Skanes universitetssjukhusRecruiting
Lund, Sweden
SodersjukhusetRecruiting
Stockholm, Sweden
Karolinska UniversitetssjukhusetRecruiting
Stockholm, Sweden
Uppsala UniversityRecruiting
Uppsala, Sweden
Kaohsiung Medical University Chung Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial HospitalRecruiting
Kaohsiung City, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Linkou Chang Gung Memorial HospitalRecruiting
Taoyuan District, Taiwan
Adana City HospitalRecruiting
Adana, Turkey (Türkiye)
Gulhane Egitim ve Arastirma HastanesiRecruiting
Ankara, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research HospitalRecruiting
Ankara, Turkey (Türkiye)
Gazi Universitesi HastanesiRecruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir HastanesiRecruiting
Ankara, Turkey (Türkiye)
Bakirkoy Training and Research HospitalRecruiting
Istanbul, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma HastanesiRecruiting
Istanbul, Turkey (Türkiye)
Necmettin Erbakan Universitesi Tip Fakultesi HastanesiRecruiting
Konya, Turkey (Türkiye)
Sakarya University Training and Research HospitalRecruiting
Sakarya, Turkey (Türkiye)
Birmingham Heartlands HospitalRecruiting
Birmingham, United Kingdom
Addenbrooke's HospitalRecruiting
Cambridge, United Kingdom
Western General HospitalRecruiting
Edinburgh, United Kingdom
Castle Hill HospitalRecruiting
Hull, United Kingdom
St James University HospitalRecruiting
Leeds, United Kingdom
St Bartholomew's HospitalRecruiting
London, United Kingdom
University College HospitalRecruiting
London, United Kingdom
Mount Vernon Cancer CentreRecruiting
Northwood, United Kingdom
Royal Marsden Hospital (Sutton)Recruiting
Sutton, United Kingdom