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Search / Trial NCT06750094

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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Dec 20, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients with colorectal cancer that has not responded to previous chemotherapy. Specifically, it is comparing the effectiveness of a combination of a drug called amivantamab with a standard chemotherapy regimen (known as FOLFIRI) against another combination of treatments that includes cetuximab or bevacizumab along with FOLFIRI. The goal is to see which treatment helps patients live longer without their disease worsening and to determine overall survival rates.

To participate in this study, individuals must be diagnosed with a specific type of colorectal cancer that hasn't been treated successfully before and must have certain genetic characteristics, specifically having wild-type KRAS, NRAS, and BRAF genes. Participants should also have measurable disease and a good performance status, meaning they are generally well enough to engage in normal activities. Throughout the trial, participants will receive close monitoring and care, and they will contribute to important research that may help improve treatment options for future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
  • Be diagnosed to have KRAS, NRAS, and BRAF wild-type (WT) tumor as determined by local testing
  • Must agree to the submission of fresh or archival tumor tissue post-progression from the most recent therapy, if clinically feasible
  • Have measurable disease according to RECIST v1.1
  • Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
  • Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy
  • Exclusion Criteria:
  • Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
  • Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI
  • Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is 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 who has not received immunotherapy treatments
  • Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
  • Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)

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.

Locations

Saint Louis, Missouri, United States

Philadelphia, Pennsylvania, United States

Baton Rouge, Louisiana, United States

Temple, Texas, United States

Pessac, , France

Bangkok, , Thailand

Hong Kong, , Hong Kong

Cleveland, Ohio, United States

Denver, Colorado, United States

Houston, Texas, United States

Bangkok, , Thailand

Rozzano, , Italy

Mumbai, , India

Kortrijk, , Belgium

Hull, , United Kingdom

London, , United Kingdom

Los Angeles, California, United States

Athens, Georgia, United States

Shatin, , Hong Kong

Kuala Lumpur, , Malaysia

Atlanta, Georgia, United States

Rotterdam, , Netherlands

London, , United Kingdom

Chiang Mai, , Thailand

Taichung, , Taiwan

Taipei, , Taiwan

Kuala Lumpur, , Malaysia

Nashville, Tennessee, United States

Stockholm, , Sweden

London, , United Kingdom

Tainan, , Taiwan

Stockholm, , Sweden

Edegem, , Belgium

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Leeds, , United Kingdom

Chengdu, , China

Szeged, , Hungary

Hattiesburg, Mississippi, United States

Beijing, , China

Shanghai, , China

Guangzhou, Guangdong, China

Petach Tikva, , Israel

Delhi, , India

Pecs, , Hungary

Hangzhou, , China

Beijing, , China

Northwood, , United Kingdom

Lacey, Washington, United States

Leuven, , Belgium

Harbin, , China

Nijmegen, , Netherlands

Pisa, , Italy

Songkhla, , Thailand

Atlanta, Georgia, United States

Gent, , Belgium

Jonesboro, Arkansas, United States

Seoul, , Korea, Republic Of

Taipei, , Taiwan

Tianjin, , China

Chandler, Arizona, United States

Ann Arbor, Michigan, United States

Tel Aviv, , Israel

Santa Monica, California, United States

Omaha, Nebraska, United States

Kuching, , Malaysia

Chihuahua, , Mexico

Anderlecht, , Belgium

Wuhan, , China

Haifa, , Israel

Beijing, , China

Amersfoort, , Netherlands

Orlando, Florida, United States

Nanchang, , China

Daegu, , Korea, Republic Of

Concord, , Australia

Avignon Cedex 9, , France

Suita Shi, , Japan

Jerusalem, , Israel

Chattanooga, Tennessee, United States

Amsterdam, , Netherlands

Kaohsiung City, , Taiwan

Taoyuan, , Taiwan

Gothenburg, , Sweden

Changsha, Hunan, China

Baltimore, Maryland, United States

Padova, , Italy

Madrid, , Spain

Madrid, , Spain

Valencia, , Spain

Eger, , Hungary

Seoul, , Korea, Republic Of

Madrid, , Spain

Changchun, , China

Barcelona, , Spain

Pamplona, , Spain

Sevilla, , Spain

Fort Myers, Florida, United States

Pune, , India

Bakersfield, California, United States

Istanbul, , Turkey

Atlanta, Georgia, United States

Los Alamitos, California, United States

Tilburg, , Netherlands

Liege, , Belgium

East Brunswick, New Jersey, United States

Norwich, Connecticut, United States

Hangzhou, , China

Tyler, Texas, United States

Ankara, , Turkey

Konya, , Turkey

San Antonio, Texas, United States

Ankara, , Turkey

Adana, , Turkey

Mainz, , Germany

Ipoh, , Malaysia

Shenyang, , China

Udine, , Italy

Puebla, , Mexico

Santa Rosa, California, United States

Sakarya, , Turkey

Brasov, , Romania

Lanzhou, , China

Kaohsiung City, , Taiwan

Georgetown, , Malaysia

Vellore, , India

Torrance, California, United States

Lund, , Sweden

Munich, , Germany

Aurora, Colorado, United States

Ankara, , Turkey

Caxias Do Sul, , Brazil

Hyderabad, , India

Shirley, New York, United States

Nashville, Tennessee, United States

Huizhou, , China

Sao Paulo, , Brazil

Guangzhou, , China

Kashiwa, , Japan

Tokyo, , Japan

Glendale, California, United States

Ankara, , Turkey

Queretaro, , Mexico

Bronx, New York, United States

Chuo Ku, , Japan

Osaka Sayama Shi, , Japan

Tel Aviv Yafo, , Israel

Richmond, Virginia, United States

Grand Rapids, Michigan, United States

Biala Podlaska, , Poland

Putrajaya, , Malaysia

Dallas, Texas, United States

Seoul, , Korea, Republic Of

Jau, , Brazil

Porto Alegre, , Brazil

Osaka City, , Japan

Sao Paulo, , Brazil

Shizuoka, , Japan

Milano, , Italy

Haine Saint Paul La Louviere, , Belgium

Brzozow, , Poland

Bucuresti, , Romania

Kaohsiung, , Taiwan

Barcelona, , Spain

Pittsburgh, Pennsylvania, United States

Beer Yaakov, , Israel

Chiba, , Japan

Berlin, , Germany

Nagoya Shi, , Japan

Guangzhou, , China

Sao Jose Do Rio Preto, , Brazil

Osaka Shi, , Japan

Ramat Gan, Hamerkaz, Israel

Heidelberg, , Australia

South Woodville, , Australia

St Albans, , Australia

Barrio Monacillos, , Puerto Rico

Gdansk, , Poland

Lodz, , Poland

Ganzhou, , China

Uppsala, , Sweden

Gliwice, , Poland

İstanbul, , Turkey

Barretos, , Brazil

Vitoria, , Brazil

Kolkata, , India

Olsztyn, , Poland

Opole, , Poland

Warszawa, , Poland

Frankfurt Am Main, , Germany

Bialystok, , Poland

Miami Beach, Florida, United States

San Juan, , Puerto Rico

Craiova, , Romania

Suita City, , Japan

Poitiers Cedex, , France

Salvador, , Brazil

Guangzhou, , China

Ciudad De Mexico, , Mexico

Guadalajara, , Mexico

Queretaro, , Mexico

Saint Petersburg, Florida, United States

West Palm Beach, Florida, United States

Abilene, Texas, United States

Varanasi, , India

Prescott, Arizona, United States

Mineola, New York, United States

New York, New York, United States

Heidelberg, , Germany

Tijuana, , Mexico

Arlington, Virginia, United States

Penn Wynne, Pennsylvania, United States

Patients applied

0 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