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Open, Randomized, Controlled, Multicenter Phase III Study Comparing CMAB009 Plus FOLFIRI Versus FOLFIRI Alone as First-line Treatment for Epidermal Growth Factor Receptor-expressing, RAS/BRAF Wild-type, Metastatic Colorectal Cancer

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Trial Profile

Open, Randomized, Controlled, Multicenter Phase III Study Comparing CMAB009 Plus FOLFIRI Versus FOLFIRI Alone as First-line Treatment for Epidermal Growth Factor Receptor-expressing, RAS/BRAF Wild-type, Metastatic Colorectal Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2024

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At a glance

  • Drugs Cetuximab (Primary) ; Fluorouracil; Folinic acid; Irinotecan
  • Indications Adenocarcinoma; Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Taizhou Mabtech Pharmaceuticals
  • Most Recent Events

    • 26 Jun 2024 According to a Simcere Pharmaceutical Group media release, the company has recently received approval from the China National Medical Administration (NMPA) for marketing. Enlituo is indicated for use in combination with the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC).
    • 09 Apr 2024 Planned End Date changed from 30 Jun 2023 to 30 Jun 2024.
    • 18 Oct 2022 Planned End Date changed from 30 Jun 2022 to 30 Jun 2023.

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