Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Glendale, California and other locations
Dates
study started
study ends around
Principal Investigator
by J. Randolph Hecht, MD
Headshot of J. Randolph Hecht
J. Randolph Hecht

Description

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 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.

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

Keywords

Colorectal Neoplasms, Leucovorin, Oxaliplatin, Fluorouracil, Irinotecan, Cetuximab, Amivantamab-vmjw, Calcium, Levoleucovorin, Amivantamab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin, Irinotecan Hydrochloride

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • Los Angeles Cancer Network accepting new patients
    Glendale California 91204 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States
  • Torrance Memorial Physicians Network accepting new patients
    Torrance California 90505 United States
  • Cancer and Blood Specialty Clinic accepting new patients
    Los Alamitos California 90720 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
Sign up for this study
ID
NCT06662786
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1000 study participants
Last Updated