AzTrials
AzTrials

Colorectal NeoplasmsPhase 3OrigAMI-2NCT06662786

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

A Phase 3 study testing Amivantamab, Cetuximab and 5-fluorouracil in people with Colorectal Neoplasms, run by Janssen Research & Development, LLC at 239 sites in 22 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
Amivantamab, Cetuximab and 5-fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
239 sitesin 22 countries
Study dates
18 Oct 2024to 20 Jan 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

239 sites in 22 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

239 sites in 22 countries

United States81 sites, 81 recruiting

  • Texas Oncology West Texas

    Abilene, Texas, 79606

    Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

    Recruiting

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48105

    Recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting

  • Virginia Cancer Specialists

    Arlington, Virginia, 22201

    Recruiting

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

    Recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

    Recruiting

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • CBCC Global Research

    Bakersfield, California, 93309

    Recruiting

  • MedStar Franklin Square Medical Center

    Baltimore, Maryland, 21237

    Recruiting

  • St Charles Medical Center

    Bend, Oregon, 97701

    Recruiting

  • Gabrail Cancer Center

    Canton, Ohio, 44718

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion

    Cleveland, Ohio, 44111

    Recruiting

  • Taussig Cancer Insititute Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • Texas Oncology DFW

    Dallas, Texas, 75246

    Recruiting

  • UT Southwestern

    Dallas, Texas, 75390

    Recruiting

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

    Recruiting

  • Swedish Cancer Institute Edmonds

    Edmonds, Washington, 98026

    Recruiting

  • Inova Schar Cancer Institute Dept of Fairfax Hospital

    Fairfax, Virginia, 22031

    Recruiting

  • Florida Cancer Specialists South

    Fort Myers, Florida, 33901

    Recruiting

  • Fort Wayne Medical Oncology & Hematology

    Fort Wayne, Indiana, 46804

    Recruiting

  • Frederick Health Hospital - James M Stockman Cancer Institute

    Frederick, Maryland, 21702-4337

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Recruiting

  • Los Angeles Cancer Network

    Glendale, California, 91204

    Recruiting

  • Cancer And Hematology Centers of Western Michigan PC

    Grand Rapids, Michigan, 49503

    Recruiting

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Cleveland Clinic Cancer Center Independence Family Health Center

    Independence, Ohio, 44131

    Recruiting

  • University of Iowa Hospital

    Iowa City, Iowa, 52242

    Recruiting

  • Swedish Cancer Institute Issaquah

    Issaquah, Washington, 98029

    Recruiting

  • St. Bernard's Medical Center

    Jonesboro, Arkansas, 72401

    Recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

    Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Recruiting

  • William S. Middleton Memorial VA

    Madison, Wisconsin, 53705

    Recruiting

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio, 44906

    Recruiting

  • Cleveland Clinic Cancer Center Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

    Recruiting

  • Perlmutter Cancer Center at NYU Long Island

    Mineola, New York, 11501

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Rutgers Cancer Institute

    New Brunswick, New Jersey, 08901

    Recruiting

  • Yale University School Of Medicine

    New Haven, Connecticut, 06519

    Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

    Recruiting

  • Mount Sinai

    New York, New York, 10003

    Recruiting

  • Mount Sinai West

    New York, New York, 10009

    Recruiting

  • NYU Langone Medical Center NYU Hematology Associates

    New York, New York, 10016

    Recruiting

  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

    New York, New York, 10032

    Recruiting

  • Nebraska Cancer Specialists Midwest Cancer Center

    Omaha, Nebraska, 68130

    Recruiting

  • AdventHealth Medical Group Oncology and Hematology at Orlando

    Orlando, Florida, 32804

    Recruiting

  • Illinois CancerCare

    Peoria, Illinois, 61615

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232 1301

    Recruiting

  • Oregon Health And Science University

    Portland, Oregon, 97239

    Recruiting

  • Richmond VA Medical Center

    Richmond, Virginia, 23249

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Recruiting

  • Baylor Scott and White Health 1

    Round Rock, Texas, 78665

    Recruiting

  • Texas Oncology - San Antonio

    San Antonio, Texas, 78240

    Recruiting

  • Cleveland Clinic Cancer Centers Sandusky

    Sandusky, Ohio, 44870

    Recruiting

  • UCLA

    Santa Monica, California, 90404

    Recruiting

  • Providence Medical Foundation

    Santa Rosa, California, 95403

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

    Recruiting

  • New York Cancer and Blood Specialists

    Shirley, New York, 11967

    Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

    Recruiting

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • Florida Cancer Specialists North Region

    St. Petersburg, Florida, 33701-4553

    Recruiting

  • Cleveland Clinic Cancer Center Strongsville

    Strongsville, Ohio, 44136

    Recruiting

  • Baylor Scott and White Health

    Temple, Texas, 76508

    Recruiting

  • Montefiore Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

    Recruiting

  • Torrance Memorial Physicians Network

    Torrance, California, 90505

    Recruiting

  • Cleveland Clinic Cancer Center South Pointe Hospital

    Warrensville Heights, Ohio, 44122

    Recruiting

  • Georgetown Univ Medical Center Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

    Recruiting

  • Mission Cancer Blood

    Waukee, Iowa, 50263

    Recruiting

  • Florida Cancer Specialists East

    West Palm Beach, Florida, 33401-3406

    Recruiting

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

    Recruiting

  • University of Buffalo Kaleida Health Cancer Care

    Williamsville, New York, 14221

    Recruiting

  • Wooster Milltown Specialty and Surgery Center

    Wooster, Ohio, 44691

    Recruiting

Other trials in United States

China22 sites, 22 recruiting

  • Peking University First Hospital

    Beijing, 100034

    Recruiting

  • Beijing Friendship Hospital Capital Medical University

    Beijing, 100050

    Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Recruiting

  • Peking University Third Hospital

    Beijing, 100191

    Recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, 130021

    Recruiting

  • Hunan Cancer hospital

    Changsha, 410013

    Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510062

    Recruiting

  • The Sixth Affiliated Hospital Sun Yat sen University

    Guangzhou, 510655

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, 519041

    Recruiting

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, 310009

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Recruiting

  • Harbin medical university cancer hospital

    Harbin, 150081

    Recruiting

  • Huizhou Central People's Hospital

    Huizhou, 516001

    Recruiting

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Recruiting

  • Liaoning Cancer Hospital and Institute

    Shenyang, 110042

    Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, 518036

    Recruiting

  • West China Hospital of Sichuan University

    Sichuan, 610044

    Recruiting

  • First Hospital of Shanxi Medical University

    Taiyuan, 030001

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, 430079

    Recruiting

Other trials in China

Brazil11 sites, 11 recruiting

  • Fundacao Pio XII

    Barretos, 14780 070

    Recruiting

  • Fundacao Universidade de Caxias do Sul

    Caxias do Sul, 95070 560

    Recruiting

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17210 080

    Recruiting

  • Hospital Nossa Senhora da Conceicao S A

    Porto Alegre, 91350 200

    Recruiting

  • Hospital Santa Izabel Santa Casa de Misericordia da Bahia

    Salvador, 40050 410

    Recruiting

  • Clinica de Hematologia e Oncologia Viver Ltda

    Santa Maria, 97015 450

    Recruiting

  • Funfarme Sjrp

    São José do Rio Preto, 15090-000

    Recruiting

  • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246 000

    Recruiting

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

    Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05651 900

    Recruiting

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

    Vitória, 29043 260

    Recruiting

Other trials in Brazil

Germany10 sites, 10 recruiting

  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum

    Berlin, 13353

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

    Recruiting

  • Essen University Hospital

    Essen, 45147

    Recruiting

  • Krankenhaus NorthWest

    Frankfurt am Main, 60488

    Recruiting

  • Praxis fur interdisziplinare Onkologie & Hamatologie GbR

    Freiburg im Breisgau, 79110

    Recruiting

  • Asklepios Klinik Altona

    Hamburg, 22763

    Recruiting

  • National Center for Tumor Diseases NCT

    Heidelberg, 69120

    Recruiting

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz

    Mainz, 55131

    Recruiting

  • Klinikum der Universitaet Muenchen

    Munich, 81377

    Recruiting

  • Universitatsklinikum Ulm

    Ulm, 89081

    Recruiting

Other trials in Germany

France9 sites, 9 recruiting

  • Institut Sainte Catherine

    Avignon, 84918

    Recruiting

  • Hopital Claude Huriez

    Lille, 59000

    Recruiting

  • Hopital Prive Jean Mermoz

    Lyon, 69008

    Recruiting

  • Institut du Cancer de Montpellier

    Montpellier, 34298

    Recruiting

  • CHU Nantes

    Nantes, 44000

    Recruiting

  • Hopital Saint Antoine

    Paris, 75571

    Recruiting

  • Hopital Haut Leveque

    Pessac, 33604

    Recruiting

  • CHU De Poitiers

    Poitiers, 86000

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

Japan9 sites, 9 recruiting

  • Chiba Cancer Center

    Chiba, 260 0801

    Recruiting

  • National Cancer Center Hospital

    Chūōku, 104 0045

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277 8577

    Recruiting

  • Aichi Cancer Center

    Nagoya, 464-8681

    Recruiting

  • National Hospital Organization Osaka National Hospital

    Osaka, 540 0006

    Recruiting

  • Osaka International Cancer Institute

    Osaka, 541 8567

    Recruiting

  • Shizuoka Cancer Center

    Shizuoka, 411 8777

    Recruiting

  • The University of Osaka Hospital

    Suita, 565 0871

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

    Recruiting

Other trials in Japan

Poland9 sites, 7 recruiting

  • Wojewodzki Szpital Specjalistyczny

    Biała Podlaska, 21 500

    Completed

  • Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku

    Bialystok, 15 027

    Recruiting

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

    Brzozów, 36 200

    Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

    Recruiting

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

    Gliwice, 44 100

    Recruiting

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93 339

    Completed

  • Szpital Kliniczny MSWiA z WMCO

    Olsztyn, 10 228

    Recruiting

  • SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego

    Opole, 45 061

    Recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02 781

    Recruiting

Other trials in Poland

Turkey (Türkiye)9 sites, 9 recruiting

  • Adana City Hospital

    Adana, 01060

    Recruiting

  • Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010

    Recruiting

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200

    Recruiting

  • Gazi Universitesi Hastanesi

    Ankara, 06560

    Recruiting

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

    Recruiting

  • Bakirkoy Training and Research Hospital

    Istanbul, 34147

    Recruiting

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

    Istanbul, 34899

    Recruiting

  • Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi

    Konya, 42090

    Recruiting

  • Sakarya University Training and Research Hospital

    Sakarya, 54290

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom9 sites, 9 recruiting

  • Birmingham Heartlands Hospital

    Birmingham, B9 5ST

    Recruiting

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

    Recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU

    Recruiting

  • Castle Hill Hospital

    Hull, HU16 5JQ

    Recruiting

  • St James University Hospital

    Leeds, LS9 7TF

    Recruiting

  • St Bartholomew's Hospital

    London, EC1A 7BE

    Recruiting

  • University College Hospital

    London, NW1 2BU

    Recruiting

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN

    Recruiting

  • Royal Marsden Hospital (Sutton)

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

Spain8 sites, 8 recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

    Recruiting

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08041

    Recruiting

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

    Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008

    Recruiting

  • Hosp. Virgen Del Rocio

    Seville, 41013

    Recruiting

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

Belgium7 sites, 6 recruiting

  • Institut Jules Bordet

    Anderlecht, 1070

    Recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

    Recruiting

  • AZ Maria Middelares

    Ghent, 9000

    Active, not recruiting

  • Hopital de Jolimont

    Haine Saint Paul La Louviere, 7100

    Recruiting

  • Az Groeninge

    Kortrijk, 8500

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liège, 4000

    Recruiting

Other trials in Belgium

Israel7 sites, 6 recruiting

  • Yitzhak Shamir Medical Center

    Beer Yaakov, 70300

    Recruiting

  • Rambam Medical Center

    Haifa, 3109601

    Recruiting

  • Hadassah University Hospita Ein Kerem

    Jerusalem, 9112001

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492

    Recruiting

  • Sheba Medical Center

    Ramat Gan, 52621

    Completed

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

    Recruiting

  • Assuta MC

    Tel Aviv, 69710

    Recruiting

Other trials in Israel

Malaysia7 sites, 7 recruiting

  • Hospital Canselor Tuanku Muhriz UKM

    Cheras, 56000

    Recruiting

  • Hospital Pulau Pinang

    George Town, 10450

    Recruiting

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30450

    Recruiting

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

    Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

    Recruiting

  • Hospital Umum Sarawak

    Kuching, 93586

    Recruiting

  • National Cancer Institute

    Putrajaya, 62250

    Recruiting

Other trials in Malaysia

Netherlands6 sites, 6 recruiting

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

    Recruiting

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX

    Recruiting

  • Radboud University Medical Center

    Nijmegen, 6525 GA

    Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD

    Recruiting

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, 5022 GC

    Recruiting

  • UMC Utrecht

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

South Korea6 sites, 6 recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

    Recruiting

Other trials in South Korea

India5 sites, 5 recruiting

  • Rajiv Gandhi Cancer Institute and Research Centre

    Delhi, 110085

    Recruiting

  • B P Poddar Hospital and Medical research Limited

    Kolkata, 700053

    Recruiting

  • Tata Memorial Hospital

    Mumbai, 400012

    Recruiting

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, 411004

    Recruiting

  • Mahamana Pandit Madan Mohan Malviya Cancer Centre

    Varanasi, 221005

    Recruiting

Other trials in India

Italy5 sites, 5 recruiting

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

    Meldola, 47014

    Recruiting

  • Istituto Dei Tumori Di Milano

    Milan, 20133

    Recruiting

  • Istituto Oncologico Veneto - IRCCS

    Padova, 35128

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

Other trials in Italy

Sweden5 sites, 4 recruiting

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

    Completed

  • Skanes universitetssjukhus

    Lund, 222 42

    Recruiting

  • Sodersjukhuset

    Stockholm, 118 83

    Recruiting

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76

    Recruiting

  • Uppsala University

    Uppsala, SE 751 85

    Recruiting

Other trials in Sweden

Taiwan5 sites, 5 recruiting

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756

    Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10043

    Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Canada4 sites, 4 recruiting

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Recruiting

  • Centre de Recherche du CHUM

    Montreal, Quebec, H2X 0C1

    Recruiting

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G1X6

    Recruiting

Other trials in Canada

Hungary4 sites, 3 recruiting

  • Semmelweis Egyetem

    Budapest, 1082

    Recruiting

  • Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, 3300

    Recruiting

  • Pecsi Tudomanyegyetem

    Pécs, 7624

    Completed

  • Szegedi Tudomanyegyetem

    Szeged, 6720

    Recruiting

Other trials in Hungary

Puerto Rico1 site, 1 recruiting

  • Pan American Center for Oncology Trials LLC

    Barrio Monacillos, 00935

    Recruiting

Other trials in Puerto Rico

About this study

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

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.

Being tested
Amivantamab, Cetuximab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin, Oxaliplatin
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmivantamabBiological

    Also called JNJ-61186372

    Amivantamab will be administered.

  • CetuximabBiological

    Also called Erbitux

    Cetuximab will be administered.

  • 5-fluorouracilDrug

    5-fluorouracil will be administered as chemotherapy regimen.

  • Leucovorin calcium/LevoleucovorinDrug

    Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.

  • OxaliplatinDrug

    Oxaliplatin will be administered as chemotherapy regimen.

  • Irinotecan HydrochlorideDrug

    Irinotecan hydrochloride will be administered as chemotherapy regimen.

Study groups in NCT06662786
Study groupRoleWhat they receive
Arm A: Amivantamab in Combination With ChemotherapyExperimentalParticipants will receive amivantamab in combination with chemotherapy (mFOLFOX6 [chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and oxaliplatin] or FOLFIRI [chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride]) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.
Receives: Biological: Amivantamab; Drug: 5-fluorouracil; Drug: Leucovorin calcium/Levoleucovorin; Drug: Oxaliplatin; Drug: Irinotecan Hydrochloride
Arm B: Cetuximab in Combination With ChemotherapyActive comparatorParticipants will receive cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.
Receives: Biological: Cetuximab; Drug: 5-fluorouracil; Drug: Leucovorin calcium/Levoleucovorin; Drug: Oxaliplatin; Drug: Irinotecan Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)

    PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v) 1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date.

    Measured: Up to 4 years and 2 months

Secondary outcomes (20)

  1. Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of participant's death due to any cause. Any participant not known to have died at the time of analysis will be censored based on the last recorded date on which the participant was known to be alive.

    Measured: Up to 7 Years 3 Months

  2. Objective Response Rate (ORR) as Assessed by BICR

    ORR is defined as the proportion of randomized participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR), as determined by BICR using RECIST v1.1 criteria. BOR is defined as best response recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent systemic anti cancer therapy or date of curative-intent procedure, whichever occurs first.

    Measured: Up to 7 Years 3 Months

  3. Objective Response Rate (ORR) as Assessed by Investigator

    ORR is defined as the percentage of randomized participants achieving complete CR or PR, as assessed by the investigator.

    Measured: Up to 7 Years 3 Months

  4. Progression Free Survival (PFS) as Assessed by Investigator

    PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by the investigator. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable disease assessment date.

    Measured: Up to 7 Years 3 Months

  5. Duration of Response (DOR) as Assessed by BICR

    DOR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as assessed by BICR using RECIST v1.1 criteria.

    Measured: Up to 7 Years 3 Months

  6. Duration of Response (DOR) as Assessed Investigator

    DOR is defined as time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR, as assessed by the investigator.

    Measured: Up to 7 Years 3 Months

  7. Time to Response (TTR) as Assessed by BICR

    TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by BICR.

    Measured: Up to 7 Years 3 Months

  8. Time to Response as Assessed by Investigator

    TTR is defined as the time from the date of randomization to the date of first documentation of a response (PR or CR) prior to any disease progression or subsequent systemic anti-cancer therapy or curative-intent procedure, for participants who have PR or CR as BOR, as assessed by investigator.

    Measured: Up to 7 Years 3 Months

  9. Progression-free Survival After Subsequent Therapy (PFS2)

    PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first.

    Measured: Up to 7 Years 3 Months

  10. Disease Control Rate (DCR) as Assessed by BICR

    DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by BICR using RECIST v1.1 criteria.

    Measured: Up to 7 Years 3 Months

  11. Disease Control Rate (DCR) as Assessed by Investigator

    DCR is defined as the percentage of randomized participants achieving CR, PR, or stable disease (with minimum duration of 7 weeks) as assessed by the investigator.

    Measured: Up to 7 Years 3 Months

  12. Time to Treatment Failure

    Time to treatment failure is defined as time from randomization to discontinuation of therapy for any reason including death, progression, toxicity, or initiation of new anticancer therapy.

    Measured: Up to 7 Years 3 Months

  13. Curative Resection (R0) Rate

    Curative resection (R0) rate is defined as the proportion of participants from the analysis set who underwent curative-intent surgery, where the residual tumor classification was R0.

    Measured: Up to 7 Years 3 Months

  14. Number of Participants with Adverse Events (AEs) by Severity

    An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. AE severity will be graded according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) v5.0. by using the standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.

    Measured: Up to 7 Years 3 Months

  15. Number of Participants with Abnormalities in Laboratory Values

    Participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.

    Measured: Up to 7 Years 3 Months

  16. Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score

    The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the health-related quality of life (HRQoL) of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms.

    Measured: From Baseline up to 7 Years 3 Months

  17. Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-C30

    The EORTC QLQ-C30, is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales, 3 symptom scales, a global health status / quality of life scale, and 6 single items. Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptom.

    Measured: Up to 7 Years 3 Months

  18. Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC-QLQ-C29) Score

    The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms.

    Measured: From Baseline up to 7 Years 3 Months

  19. Time to Worsening in Symptoms and Functioning as Measured by EORTC QLQ-CR29

    The EORTC QLQ-CR29, is a self-administered, 29-item questionnaire measuring the HRQoL of participants with colorectal cancer. The QLQ CR29 includes items that evaluate symptoms (gastrointestinal, urinary, pain, and others) and functional areas (sexual, body image, weight, and anxiety) that are associated with colorectal cancer and its treatments. Responses are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much". All scores are linearly converted into a scale from 0 to 100. Higher scores indicate greater functioning and more severe symptoms.

    Measured: Up to 7 Years 3 Months

  20. Overall Side Effect Burden as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Item 168 Scale Score

    The EORTC item 168 is a single item used to measure the overall impact of treatment side effects. Responses are rated on a 4-point Likert response scale ranging from 1 "not at all" to 4 "very much." Higher scores indicate severe side effects.

    Measured: Up to 7 Years 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start18 Oct 2024
  3. Primary completion15 Dec 2028 (estimated)
  4. Study completion20 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06662786
Sponsor's protocol ID
61186372COR3001
Other IDs
2024-513852-13-00
Acronym
OrigAMI-2
Status last verified
Nov 2026
First submitted
28 Oct 2024
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amivantamab, Cetuximab and 5-fluorouracil in people with Colorectal Neoplasms, run by Janssen Research & Development, LLC at 239 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 239 sites in United States, China, Brazil, Germany, France and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to 4 years and 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06662786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in