Last updated 10 days ago
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
1000 patients around the world
Available in Puerto Rico, Brazil
Janssen Research & Development, LLC
2Research sites
1000Patients around the world
This study is for people with
Colorectal cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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).
Sites
AC Camargo Cancer Center
Recruiting
Pan American Center for Oncology Trials
Recruiting
StudyOrigAMI-2
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Colorectal cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06662786
