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
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Oct 28, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is examining two different treatment options for adults with advanced left-sided colorectal cancer that cannot be surgically removed. The researchers want to find out which treatment helps people stay disease-free for longer. One group of participants will receive a combination of a new drug called amivantamab along with standard chemotherapy, while the other group will receive cetuximab (another type of drug) with the same chemotherapy.
To be eligible for this study, participants must have a specific type of colorectal cancer that is confirmed by a doctor and cannot be surgically removed. They also need to have a certain genetic profile (KRAS, NRAS, and BRAF wild-type), and their cancer must be measurable. Additionally, participants should be generally healthy with a good performance status. The trial is currently recruiting participants, and those who join can expect to receive careful monitoring and support throughout their treatment. It’s important for potential participants to discuss this opportunity with their healthcare team to see if it’s the right fit for them.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
- • Be diagnosed 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 as determined by local testing
- • Must agree to the submission of fresh tumor tissue
- • Have measurable disease according to RECIST v1.1
- • 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 unlikely 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) or mesenchymal epithelial transition (MET)
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Saint Louis, Missouri, United States
Philadelphia, Pennsylvania, United States
Seattle, Washington, United States
New Orleans, Louisiana, United States
Pessac, , France
Ramat Gan, , Israel
Chapel Hill, North Carolina, United States
Denver, Colorado, United States
Houston, Texas, United States
Albuquerque, New Mexico, United States
Philadelphia, Pennsylvania, United States
Rozzano, , Italy
Mumbai, , India
Kortrijk, , Belgium
Hull, , United Kingdom
London, , United Kingdom
Goteborg, , Sweden
Los Angeles, California, United States
New Haven, Connecticut, United States
Kuala Lumpur, , Malaysia
Ann Arbor, Michigan, United States
Ottawa, Ontario, Canada
Taipei, , Taiwan
Atlanta, Georgia, United States
Rotterdam, , Netherlands
Utrecht, , Netherlands
Taipei, , Taiwan
Kuala Lumpur, , Malaysia
Villejuif, , France
Edinburgh, , United Kingdom
Stockholm, , Sweden
London, , United Kingdom
Tainan, , Taiwan
Stockholm, , Sweden
Tainan, , Taiwan
Ulm, , Germany
Strongsville, Ohio, United States
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Las Vegas, Nevada, United States
Leeds, , United Kingdom
Edegem, , Belgium
Hamburg, , Germany
Szeged, , Hungary
Hattiesburg, Mississippi, United States
Cambridge, , United Kingdom
Beijing, , China
Shanghai, , China
Delhi, , India
Pecs, , Hungary
Meldola, , Italy
Hangzhou, , China
Beijing, , China
Mansfield, Ohio, United States
Lyon, , France
Northwood, , United Kingdom
Leuven, , Belgium
Harbin, , China
Nijmegen, , Netherlands
Pisa, , Italy
Budapest, , Hungary
Essen, , Germany
Gent, , Belgium
Kashiwa, , Japan
Jonesboro, Arkansas, United States
Guangzhou, Guangdong, China
Tianjin, , China
Beijing, , China
Lille, , France
Gilbert, Arizona, United States
Kuching, , Malaysia
Anderlecht, , Belgium
Wuhan, , China
Montpellier, , France
Haifa, , Israel
Kaohsiung, , Taiwan
Beijing, , China
Amersfoort, Utrecht, Netherlands
Daegu, , Korea, Republic Of
Sutton, , United Kingdom
Avignon Cedex 9, , France
Dresden, , Germany
Amsterdam, , Netherlands
Petah Tikva, , Israel
Taoyuan, , Taiwan
Baltimore, Maryland, United States
Padova, , Italy
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Konya, , Turkey
Eger, , Hungary
Seoul, , Korea, Republic Of
Edmonds, Washington, United States
Issaquah, Washington, United States
Toronto, Ontario, Canada
Madrid, , Spain
Changchun, , China
Changsha, , China
Barcelona, , Spain
Pamplona, , Spain
Sevilla, , Spain
Fort Myers, Florida, United States
Pune, , India
Bakersfield, California, United States
Putrajaya, , Malaysia
Istanbul, , Turkey
Seoul, , Korea, Republic Of
Atlanta, Georgia, United States
Montreal, Quebec, Canada
Los Alamitos, California, United States
Liege, , Belgium
East Brunswick, New Jersey, United States
Temple, Texas, United States
Birmingham, , United Kingdom
Shenzhen, , China
Ankara, , Turkey
San Antonio, Texas, United States
Ankara, , Turkey
New Brunswick, New Jersey, United States
Tilburg, , Netherlands
Adana, , Turkey
Taiyuan, , China
Mainz, , Germany
Ipoh, , Malaysia
New York, New York, United States
Hangzhou, , China
Shenyang, , China
Huizhou, Guangdong, China
Santa Rosa, California, United States
Sichuan, Chengdu, China
Sakarya, , Turkey
Fort Wayne, Indiana, United States
Kaohsiung City, , Taiwan
Nantes Cedex 1, , France
Georgetown, , Malaysia
Torrance, California, United States
Lund, , Sweden
Munich, , Germany
Ankara, , Turkey
Caxias Do Sul, , Brazil
Shirley, New York, United States
Nashville, Tennessee, United States
Nanchang, Jiangxi, China
Hangzhou, , China
Sao Paulo, , Brazil
Guangzhou, , China
Kashiwa, , Japan
Tokyo, , Japan
Glendale, California, United States
Ankara, , Turkey
Bronx, New York, United States
Chuo Ku, , Japan
Tel Aviv Yafo, , Israel
Wooster, Ohio, United States
Biala Podlaska, , Poland
Dallas, Texas, United States
New York, New York, United States
Jau, , Brazil
Porto Alegre, , Brazil
Osaka City, , Japan
Shizuoka, , Japan
Suita, , Japan
Haine Saint Paul La Louviere, , Belgium
Milano, , Italy
Brzozow, , Poland
Jerusalem, , Israel
Kaohsiung, , Taiwan
Barcelona, , Spain
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Beer Yaakov, , Israel
Chiba, , Japan
Berlin, , Germany
Nagoya Shi, , Japan
Guangzhou, , China
Sao Jose Do Rio Preto, , Brazil
Calgary, Alberta, Canada
Cheras, , Malaysia
Omaha, Nebraska, United States
Osaka Shi, , Japan
Barrio Monacillos, , Puerto Rico
Gdansk, , Poland
Tel Aviv Yafo, , Israel
Lodz, , Poland
Uppsala, , Sweden
Cleveland, Ohio, United States
Independence, Ohio, United States
Mayfield Heights, Ohio, United States
Sandusky, Ohio, United States
Warrensville Heights, Ohio, United States
Gliwice, , Poland
Warszawa, , Poland
İstanbul, , Turkey
Barretos, , Brazil
Vitoria, , Brazil
Kolkata, , India
Olsztyn, , Poland
Opole, , Poland
Santa Maria, , Brazil
Frankfurt Am Main, , Germany
Freiburg, , Germany
Bialystok, , Poland
Suita City, , Japan
Poitiers Cedex, , France
Guangzhou, , China
Washington, District Of Columbia, United States
Salvador, , Brazil
Saint Petersburg, Florida, United States
West Palm Beach, Florida, United States
New York, New York, United States
Abilene, Texas, United States
Varanasi, , India
Arlington, Virginia, United States
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported