Study Comparing Amivantamab with Chemotherapy to Cetuximab with Chemotherapy for First-line Treatment of Unresectable or Metastatic Left-sided Colorectal Cancer

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06662786

Provider View

This clinical trial is evaluating whether a combination of the drug amivantamab with chemotherapy is more effective than cetuximab with chemotherapy in treating adults with advanced left-sided colorectal cancer that cannot be surgically removed or has spread to other parts of the body.

Patient Parameters

Program Overview

The aim of this study is to compare the effectiveness of two treatment options for adults with advanced left-sided colorectal cancer that cannot be removed by surgery or has spread. The study will look at how long patients remain free from disease progression when treated with either amivantamab combined with chemotherapy drugs (mFOLFOX6 or FOLFIRI) or cetuximab combined with the same chemotherapy options. Participants must have a specific type of tumor that does not have certain genetic mutations (KRAS, NRAS, BRAF wild-type).

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with a specific type of left-sided colorectal cancer that cannot be surgically removed or has spread.
  • Tumor must not have certain genetic mutations (KRAS, NRAS, BRAF wild-type).
  • Must agree to provide a fresh tumor sample for testing.
  • Have measurable cancer that can be tracked using standard criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Have a history of or current lung diseases like interstitial lung disease, pneumonitis, or pulmonary fibrosis.
  • Have known allergies or intolerances to the study drugs or their components.
  • Have another type of cancer that could interfere with the study.
  • Have a tumor with certain genetic characteristics (mismatch repair deficiency, high microsatellite instability, or HER2-positive/amplified).
  • Have previously been treated with drugs targeting EGFR or MET.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.