Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 3INTERVENTIONAL

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 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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Have diagnosed by tissue sample (biopsy-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 - Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1 Who Should NOT Join This Trial: - 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) or mesenchymal epithelial transition (MET) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 * 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) or mesenchymal epithelial transition (MET)

Treatments Being Tested

BIOLOGICAL

Amivantamab

Amivantamab will be administered.

BIOLOGICAL

Cetuximab

Cetuximab will be administered.

DRUG

5-fluorouracil

5-fluorouracil will be administered as chemotherapy regimen.

DRUG

Leucovorin calcium/Levoleucovorin

Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.

DRUG

Oxaliplatin

Oxaliplatin will be administered as chemotherapy regimen.

DRUG

Irinotecan Hydrochloride

Irinotecan hydrochloride will be administered as chemotherapy regimen.

Locations (20)

Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
St. Bernard's Medical Center
Jonesboro, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
CBCC Global Research
Bakersfield, California, United States
Los Angeles Cancer Network
Glendale, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA
Santa Monica, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
Torrance Memorial Physicians Network
Torrance, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Georgetown Univ Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Florida Cancer Specialists South
Fort Myers, Florida, United States
AdventHealth Medical Group Oncology and Hematology at Orlando
Orlando, Florida, United States
Florida Cancer Specialists North Region
St. Petersburg, Florida, United States
Florida Cancer Specialists East
West Palm Beach, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Winship Cancer Institute Emory University
Atlanta, Georgia, United States
Illinois CancerCare
Peoria, Illinois, United States