OrigAMI-2

• Research type

  Research Study

• Full 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

• IRAS ID

  1010643

• Contact name

  Sue Linnington

• Contact email

  SLinning@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2024-513852-13

• ISRCTN Number

  ISRCTN11118663

• Research summary

  This is a randomised, open-label, active-controlled, parallel-group, multicentre, interventional, Phase 3 study of amivantamab and standard chemotherapy (mFOLFOX6 or FOLFIRI) compared with cetuximab and mFOLFOX6 or FOLFIRI in adult participants who have unresectable (unable to be removed with surgery) or metastatic (cancer that has spread from its original site) left-sided colorectal cancer (CRC) that lacks mutations in genes called KRAS/NRAS and BRAF.

  Despite recent advances in the treatment of metastatic CRC, patients continue to experience significant morbidity and mortality, underscoring the need to improve therapeutic approaches. The purpose of this study is to compare the effects of amivantamab and cetuximab in combination with chemotherapy.

  Participants in this study will be enrolled randomly (equally) into one of two study arms:
  - Arm A: Amivantamab and mFOLFOX6 or FOLFIRI
  - Arm B: Cetuximab and mFOLFOX6 or FOLFIRI

  The study will consist of a Screening period of 28-42 days, a Treatment period consisting of 28-day treatment cycles, an End of Treatment visit 30 days after the final study dose, and a Follow-up period with visits/calls every 12 weeks.

  Amivantamab is injected under the skin (subcutaneously) every week for the first treatment cycle, and then once every 2 weeks thereafter. Cetuximab will be administered through a vein in the arm (intravenously) either weekly or biweekly, depending on local practice. Chemotherapy will be delivered as per standard care.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  24/NW/0275

• Date of REC Opinion

  28 Oct 2024

• REC opinion

  Further Information Favourable Opinion