A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and... | NCT06662786 | Trialant

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and... | NCT06662786 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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)

Banner MD Anderson Cancer CenterRecruiting

Gilbert, Arizona 85234, United States

St. Bernard's Medical CenterRecruiting

Jonesboro, Arkansas 72401, United States

Highlands Oncology GroupRecruiting

Springdale, Arkansas 72762, United States

CBCC Global ResearchRecruiting

Bakersfield, California 93309, United States

Los Angeles Cancer NetworkRecruiting

Glendale, California 91204, United States

Cancer and Blood Specialty ClinicRecruiting

Los Alamitos, California 90720, United States

USC Norris Comprehensive Cancer CenterRecruiting

Los Angeles, California 90033, United States

UCLARecruiting

Santa Monica, California 90404, United States

Providence Medical FoundationRecruiting

Santa Rosa, California 95403, United States

Torrance Memorial Physicians NetworkRecruiting

Torrance, California 90505, United States

Rocky Mountain Cancer CentersRecruiting

Denver, Colorado 80218, United States

Yale University School Of MedicineRecruiting

New Haven, Connecticut 06519, United States

Georgetown Univ Medical Center Lombardi Cancer CenterRecruiting

Washington D.C., District of Columbia 20007, United States

Florida Cancer Specialists SouthRecruiting

Fort Myers, Florida 33901, United States

AdventHealth Medical Group Oncology and Hematology at OrlandoRecruiting

Orlando, Florida 32804, United States

Florida Cancer Specialists North RegionRecruiting

St. Petersburg, Florida 33701-4553, United States

Florida Cancer Specialists EastRecruiting

West Palm Beach, Florida 33401-3406, United States

Grady Memorial HospitalRecruiting

Atlanta, Georgia 30303, United States

Winship Cancer Institute Emory UniversityRecruiting

Atlanta, Georgia 30322, United States

Illinois Cancer SpecialistsRecruiting

Arlington Heights, Illinois 60005, United States

Illinois CancerCareRecruiting

Peoria, Illinois 61615, United States

Fort Wayne Medical Oncology & HematologyRecruiting

Fort Wayne, Indiana 46804, United States

University of Iowa HospitalRecruiting

Iowa City, Iowa 52242, United States

Mission Cancer BloodRecruiting

Waukee, Iowa 50263, United States

Cancer Center of KansasRecruiting

Wichita, Kansas 67214, United States

Ochsner Clinic FoundationRecruiting

New Orleans, Louisiana 70121, United States

MedStar Franklin Square Medical CenterRecruiting

Baltimore, Maryland 21237, United States

Frederick Health Hospital - James M Stockman Cancer InstituteRecruiting

Frederick, Maryland 21702-4337, United States

VA Ann Arbor Healthcare SystemRecruiting

Ann Arbor, Michigan 48105, United States

University of MichiganRecruiting

Ann Arbor, Michigan 48109, United States

Henry Ford HospitalRecruiting

Detroit, Michigan 48202, United States

Start MidwestRecruiting

Grand Rapids, Michigan 49503, United States

Hattiesburg ClinicRecruiting

Hattiesburg, Mississippi 39401, United States

Washington University School Of MedicineRecruiting

St Louis, Missouri 63110, United States

Nebraska Cancer Specialists Midwest Cancer CenterRecruiting

Omaha, Nebraska 68130, United States

Comprehensive Cancer Centers of NevadaRecruiting

Las Vegas, Nevada 89169, United States

Astera Cancer CareRecruiting

East Brunswick, New Jersey 08816, United States

Rutgers Cancer InstituteRecruiting

New Brunswick, New Jersey 08901, United States

University of New Mexico Cancer CenterRecruiting

Albuquerque, New Mexico 87102, United States

Perlmutter Cancer Center at NYU Long IslandRecruiting

Mineola, New York 11501, United States

Mount SinaiRecruiting

New York, New York 10003, United States

Mount Sinai WestRecruiting

New York, New York 10009, United States

NYU Langone Medical Center NYU Hematology AssociatesRecruiting

New York, New York 10016, United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterRecruiting

New York, New York 10032, United States

New York Cancer and Blood SpecialistsRecruiting

Shirley, New York 11967, United States

Montefiore Einstein Comprehensive Cancer CenterRecruiting

The Bronx, New York 10461, United States

University of North Carolina at Chapel HillRecruiting

Chapel Hill, North Carolina 27599, United States

Gabrail Cancer CenterRecruiting

Canton, Ohio 44718, United States

University Hospitals Cleveland Medical CenterRecruiting

Cleveland, Ohio 44106, United States

Cleveland Clinic Cancer Center Fairview Hospital Moll PavilionRecruiting

Cleveland, Ohio 44111, United States

Taussig Cancer Insititute Cleveland ClinicRecruiting

Cleveland, Ohio 44195, United States

Cleveland Clinic Cancer Center Independence Family Health CenterRecruiting

Independence, Ohio 44131, United States

Cleveland Clinic Cancer Center MansfieldRecruiting

Mansfield, Ohio 44906, United States

Cleveland Clinic Cancer Center Hillcrest HospitalRecruiting

Mayfield Heights, Ohio 44124, United States

Cleveland Clinic Cancer Centers SanduskyRecruiting

Sandusky, Ohio 44870, United States

Cleveland Clinic Cancer Center StrongsvilleRecruiting

Strongsville, Ohio 44136, United States

Cleveland Clinic Cancer Center South Pointe HospitalRecruiting

Warrensville Heights, Ohio 44122, United States

Wooster Milltown Specialty and Surgery CenterRecruiting

Wooster, Ohio 44691, United States

St Charles Medical CenterRecruiting

Bend, Oregon 97701, United States

Oregon Health And Science UniversityRecruiting

Portland, Oregon 97239, United States

Thomas Jefferson UniversityRecruiting

Philadelphia, Pennsylvania 19107, United States

Fox Chase Cancer CenterRecruiting

Philadelphia, Pennsylvania 19111, United States

University Of Pittsburgh Medical Center UPMC Hillman Cancer CenterRecruiting

Pittsburgh, Pennsylvania 15232 1301, United States

SCRI Oncology PartnersRecruiting

Nashville, Tennessee 37203, United States

Texas Oncology West TexasRecruiting

Abilene, Texas 79606, United States

Texas Oncology DFWRecruiting

Dallas, Texas 75246, United States

UT SouthwesternRecruiting

Dallas, Texas 75390, United States

MD Anderson Cancer CenterRecruiting

Houston, Texas 77030, United States

Baylor Scott and White Health 1Recruiting

Round Rock, Texas 78665, United States

Texas Oncology - San AntonioRecruiting

San Antonio, Texas 78240, United States

Baylor Scott and White HealthRecruiting

Temple, Texas 76508, United States

Virginia Cancer SpecialistsRecruiting

Arlington, Virginia 22201, United States

Inova Schar Cancer Institute Dept of Fairfax HospitalRecruiting

Fairfax, Virginia 22031, United States

Richmond VA Medical CenterRecruiting

Richmond, Virginia 23249, United States

VCU Massey Comprehensive Cancer CenterRecruiting

Richmond, Virginia 23298, United States

Swedish Cancer Institute EdmondsRecruiting

Edmonds, Washington 98026, United States

Swedish Cancer Institute IssaquahRecruiting

Issaquah, Washington 98029, United States

Swedish Cancer InstituteRecruiting

Seattle, Washington 98104, United States

Fred Hutchinson Cancer Research CenterRecruiting

Seattle, Washington 98109, United States

William S. Middleton Memorial VARecruiting

Madison, Wisconsin 53705, United States

Institut Jules BordetRecruiting

Anderlecht, 1070, Belgium

Universitair Ziekenhuis AntwerpenRecruiting

Edegem, 2650, Belgium

AZ Maria MiddelaresActive, not recruiting

Ghent, 9000, Belgium

Hopital de JolimontRecruiting

Haine Saint Paul La Louviere, 7100, Belgium

Az GroeningeRecruiting

Kortrijk, 8500, Belgium

Universitair Ziekenhuis LeuvenRecruiting

Leuven, 3000, Belgium

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart TilmanRecruiting

Liège, 4000, Belgium

Fundacao Pio XIIRecruiting

Barretos, 14780 070, Brazil

Fundacao Universidade de Caxias do SulRecruiting

Caxias do Sul, 95070 560, Brazil

Fundacao Doutor Amaral CarvalhoRecruiting

Jaú, 17210 080, Brazil

Hospital Nossa Senhora da Conceicao S ARecruiting

Porto Alegre, 91350 200, Brazil

Hospital Santa Izabel Santa Casa de Misericordia da BahiaRecruiting

Salvador, 40050 410, Brazil

Clinica de Hematologia e Oncologia Viver LtdaRecruiting

Santa Maria, 97015 450, Brazil

Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De BaseRecruiting

São José do Rio Preto, 15090 000, Brazil

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao PauloRecruiting

São Paulo, 01246 000, Brazil

Fundacao Antonio Prudente A C Camargo Cancer CenterRecruiting

São Paulo, 01509 900, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting

São Paulo, 05651 900, Brazil

Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de CassiaRecruiting

Vitória, 29043 260, Brazil

Arthur J E Child Comprehensive Cancer CentreRecruiting

Calgary, Alberta T2N 5G2, Canada

Ottawa HospitalRecruiting

Ottawa, Ontario K1H 8L6, Canada

Princess Margaret Cancer CentreRecruiting

Toronto, Ontario M5G1X6, Canada

Centre de Recherche du CHUMRecruiting

Montreal, Quebec H2X 0C1, Canada

Peking University First HospitalRecruiting

Beijing, 100034, China

Beijing Friendship Hospital Capital Medical UniversityRecruiting

Beijing, 100050, China

Beijing Cancer HospitalRecruiting

Beijing, 100142, China

Peking University Third HospitalRecruiting

Beijing, 100191, China

The First Bethune Hospital of Jilin UniversityRecruiting

Changchun, 130021, China

Hunan Cancer hospitalRecruiting

Changsha, 410013, China

Sun Yat Sen University Cancer CenterRecruiting

Guangzhou, 510062, China

The Sixth Affiliated Hospital Sun Yat sen UniversityRecruiting

Guangzhou, 510655, China

Guangdong Provincial People's HospitalRecruiting

Guangzhou, 519041, China

The First Affiliated Hospital Zhejiang University College of MedicineRecruiting

Hangzhou, 310003, China

The Second Affiliated Hospital of Zhejiang University College of MedicineRecruiting

Hangzhou, 310009, China

Zhejiang Cancer HospitalRecruiting

Hangzhou, 310022, China

Harbin medical university cancer hospitalRecruiting

Harbin, 150081, China

Huizhou Central People's HospitalRecruiting

Huizhou, 516001, China

The First Affiliated Hospital of NanChang UniversityRecruiting

Nanchang, 330006, China

Fudan University Shanghai Cancer CenterRecruiting

Shanghai, 200032, China

Liaoning Cancer Hospital and InstituteRecruiting

Shenyang, 110042, China

Peking University Shenzhen HospitalRecruiting

Shenzhen, 518036, China

West China Hospital of Sichuan UniversityRecruiting

Sichuan, 610044, China

First Hospital of Shanxi Medical UniversityRecruiting

Taiyuan, 030001, China

Tianjin Medical University Cancer Institute and HospitalRecruiting

Tianjin, 300060, China

Hubei Cancer HospitalRecruiting

Wuhan, 430079, China

Institut Sainte CatherineRecruiting

Avignon, 84918, France

Hopital Claude HuriezRecruiting

Lille, 59000, France

Hopital Prive Jean MermozRecruiting

Lyon, 69008, France

Institut du Cancer de MontpellierRecruiting

Montpellier, 34298, France

CHU NantesRecruiting

Nantes, 44000, France

Hopital Saint AntoineRecruiting

Paris, 75571, France

Hopital Haut LevequeRecruiting

Pessac, 33604, France

CHU De PoitiersRecruiting

Poitiers, 86000, France

Gustave RoussyRecruiting

Villejuif, 94805, France

Charite Universitatsmedizin Berlin Campus Virchow KlinikumRecruiting

Berlin, 13353, Germany

Universitaetsklinikum Carl Gustav Carus TU DresdenRecruiting

Dresden, 01307, Germany

Essen University HospitalRecruiting

Essen, 45147, Germany

Krankenhaus NorthWestRecruiting

Frankfurt am Main, 60488, Germany

Praxis fur interdisziplinare Onkologie & Hamatologie GbRRecruiting

Freiburg im Breisgau, 79110, Germany

Asklepios Klinik AltonaRecruiting

Hamburg, 22763, Germany

National Center for Tumor Diseases NCTRecruiting

Heidelberg, 69120, Germany

Universitatsmedizin der Johannes Gutenberg Universitat MainzRecruiting

Mainz, 55131, Germany

Klinikum der Universitaet MuenchenRecruiting

Munich, 81377, Germany

Universitatsklinikum UlmRecruiting

Ulm, 89081, Germany

Semmelweis EgyetemRecruiting

Budapest, 1082, Hungary

Markhot Ferenc Oktatokorhaz es RendelointezetRecruiting

Eger, 3300, Hungary

Pecsi TudomanyegyetemCompleted

Pécs, 7624, Hungary

Szegedi TudomanyegyetemRecruiting

Szeged, 6720, Hungary

Rajiv Gandhi Cancer Institute and Research CentreRecruiting

Delhi, 110085, India

B P Poddar Hospital and Medical research LimitedRecruiting

Kolkata, 700053, India

Tata Memorial HospitalRecruiting

Mumbai, 400012, India

Deenanath Mangeshkar Hospital and Research CentreRecruiting

Pune, 411004, India

Mahamana Pandit Madan Mohan Malviya Cancer CentreRecruiting

Varanasi, 221005, India

Yitzhak Shamir Medical CenterRecruiting

Beer Yaakov, 70300, Israel

Rambam Medical CenterRecruiting

Haifa, 3109601, Israel

Hadassah University Hospita Ein KeremRecruiting

Jerusalem, 9112001, Israel

Rabin Medical CenterRecruiting

Petah Tikva, 4941492, Israel

Sheba Medical CenterCompleted

Ramat Gan, 52621, Israel

Tel Aviv Sourasky Medical CenterRecruiting

Tel Aviv, 6423906, Israel

Assuta MCRecruiting

Tel Aviv, 69710, Israel

Istituto Scientifico Romagnolo per lo Studio e la Cura dei TumoriRecruiting

Meldola, 47014, Italy

Istituto Dei Tumori Di MilanoRecruiting

Milan, 20133, Italy

Istituto Oncologico Veneto - IRCCSRecruiting

Padova, 35128, Italy

Azienda Ospedaliero Universitaria PisanaRecruiting

Pisa, 56126, Italy

Istituto Clinico HumanitasRecruiting

Rozzano, 20089, Italy

Chiba Cancer CenterRecruiting

Chiba, 260 0801, Japan

National Cancer Center HospitalRecruiting

Chūōku, 104 0045, Japan

National Cancer Center Hospital EastRecruiting

Kashiwa, 277 8577, Japan

Aichi Cancer CenterRecruiting

Nagoya, 464-8681, Japan

National Hospital Organization Osaka National HospitalRecruiting

Osaka, 540 0006, Japan

Osaka International Cancer InstituteRecruiting

Osaka, 541 8567, Japan

Shizuoka Cancer CenterRecruiting

Shizuoka, 411 8777, Japan

The University of Osaka HospitalRecruiting

Suita, 565 0871, Japan

The Cancer Institute Hospital of JFCRRecruiting

Tokyo, 135 8550, Japan

Hospital Canselor Tuanku Muhriz UKMRecruiting

Cheras, 56000, Malaysia

Hospital Pulau PinangRecruiting

George Town, 10450, Malaysia

Hospital Raja Permaisuri BainunRecruiting

Ipoh, 30450, Malaysia

Hospital Kuala LumpurRecruiting

Kuala Lumpur, 50586, Malaysia

University Malaya Medical CentreRecruiting

Kuala Lumpur, 59100, Malaysia

Hospital Umum SarawakRecruiting

Kuching, 93586, Malaysia

National Cancer InstituteRecruiting

Putrajaya, 62250, Malaysia

Meander Medisch CentrumRecruiting

Amersfoort, 3813 TZ, Netherlands

Antoni van LeeuwenhoekRecruiting

Amsterdam, 1066 CX, Netherlands

Radboud University Medical CenterRecruiting

Nijmegen, 6525 GA, Netherlands

Erasmus MCRecruiting

Rotterdam, 3015 GD, Netherlands

Elisabeth-TweeSteden ZiekenhuisRecruiting

Tilburg, 5022 GC, Netherlands

UMC UtrechtRecruiting

Utrecht, 3584 CX, Netherlands

Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w BialymstokuRecruiting

Bialystok, 15 027, Poland

Wojewodzki Szpital SpecjalistycznyCompleted

Biała Podlaska, 21 500, Poland

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B MarkiewiczaRecruiting

Brzozów, 36 200, Poland

Uniwersyteckie Centrum KliniczneRecruiting

Gdansk, 80 214, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w GliwicachRecruiting

Gliwice, 44 100, Poland

Instytut Centrum Zdrowia Matki PolkiRecruiting

Lodz, 93 339, Poland

Szpital Kliniczny MSWiA z WMCORecruiting

Olsztyn, 10 228, Poland

SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza KoszarowskiegoRecruiting

Opole, 45 061, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyRecruiting

Warsaw, 02 781, Poland

Pan American Center for Oncology Trials LLCRecruiting

Barrio Monacillos, 00935, Puerto Rico

Kyungpook National University Chilgok HospitalRecruiting

Daegu, 41404, South Korea

Seoul National University HospitalRecruiting

Seoul, 03080, South Korea

Severance Hospital Yonsei University Health SystemRecruiting

Seoul, 03722, South Korea

Asan Medical CenterRecruiting

Seoul, 05505, South Korea

Samsung Medical CenterRecruiting

Seoul, 06351, South Korea

The Catholic University of Korea Seoul St Marys HospitalRecruiting

Seoul, 06591, South Korea

Hosp. de La Santa Creu I Sant PauRecruiting

Barcelona, 08025, Spain

Hosp Univ Vall D HebronRecruiting

Barcelona, 08035, Spain

Hosp. Gral. Univ. Gregorio MaranonRecruiting

Madrid, 28007, Spain

Hosp. Univ. Ramon Y CajalRecruiting

Madrid, 28034, Spain

Hosp. Univ. 12 de OctubreRecruiting

Madrid, 28041, Spain

Clinica Univ. de NavarraRecruiting

Pamplona, 31008, Spain

Hosp. Virgen Del RocioRecruiting

Seville, 41013, Spain

Hosp. Clinico Univ. de ValenciaRecruiting

Valencia, 46010, Spain

Sahlgrenska University HospitalCompleted

Gothenburg, 413 45, Sweden

Skanes universitetssjukhusRecruiting

Lund, 222 42, Sweden

SodersjukhusetRecruiting

Stockholm, 118 83, Sweden

Karolinska UniversitetssjukhusetRecruiting

Stockholm, 171 76, Sweden

Uppsala UniversityRecruiting

Uppsala, SE 751 85, Sweden

Kaohsiung Medical University Chung Ho Memorial HospitalRecruiting

Kaohsiung City, 80756, Taiwan

Kaohsiung Chang Gung Memorial HospitalRecruiting

Kaohsiung City, 83301, Taiwan

National Cheng Kung University HospitalRecruiting

Tainan, 704, Taiwan

National Taiwan University HospitalRecruiting

Taipei, 10043, Taiwan

Linkou Chang Gung Memorial HospitalRecruiting

Taoyuan, 333, Taiwan

Adana City HospitalRecruiting

Adana, 01060, Turkey (Türkiye)

Gulhane Egitim ve Arastirma HastanesiRecruiting

Ankara, 06010, Turkey (Türkiye)

Dr Abdurrahman Yurtaslan Oncology Training and Research HospitalRecruiting

Ankara, 06200, Turkey (Türkiye)

Gazi Universitesi HastanesiRecruiting

Ankara, 06560, Turkey (Türkiye)

Ankara Bilkent Sehir HastanesiRecruiting

Ankara, 06800, Turkey (Türkiye)

Bakirkoy Training and Research HospitalRecruiting

Istanbul, 34147, Turkey (Türkiye)

Marmara Universitesi Pendik Egitim ve Arastirma HastanesiRecruiting

Istanbul, 34899, Turkey (Türkiye)

Necmettin Erbakan Universitesi Tip Fakultesi HastanesiRecruiting

Konya, 42090, Turkey (Türkiye)

Sakarya University Training and Research HospitalRecruiting

Sakarya, 54290, Turkey (Türkiye)

Birmingham Heartlands HospitalRecruiting

Birmingham, B9 5ST, United Kingdom

Addenbrooke's HospitalRecruiting

Cambridge, CB2 0QQ, United Kingdom

Western General HospitalRecruiting

Edinburgh, EH4 2XU, United Kingdom

Castle Hill HospitalRecruiting

Hull, HU16 5JQ, United Kingdom

St James University HospitalRecruiting

Leeds, LS9 7TF, United Kingdom

St Bartholomew's HospitalRecruiting

London, EC1A 7BE, United Kingdom

University College HospitalRecruiting

London, NW1 2BU, United Kingdom

Mount Vernon Cancer CentreRecruiting

Northwood, HA6 2RN, United Kingdom

Royal Marsden Hospital (Sutton)Recruiting

Sutton, SM2 5PT, United Kingdom