A Multicenter, Randomized, Open-label, Phase III Trial to Assess Efficacy and Safety of Cetuximab When Given in Combination With Cisplatin Plus 5 Fluorouracil Versus Cisplatin Plus 5-fluorouracil Alone for the First-line Treatment of Chinese Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Trial Profile

A Multicenter, Randomized, Open-label, Phase III Trial to Assess Efficacy and Safety of Cetuximab When Given in Combination With Cisplatin Plus 5 Fluorouracil Versus Cisplatin Plus 5-fluorouracil Alone for the First-line Treatment of Chinese Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Oct 2017

At a glance

  • Drugs Cetuximab (Primary) ; Cisplatin; Fluorouracil
  • Indications Head and neck cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms CHANGE2
  • Sponsors Merck KGaA
  • Most Recent Events

    • 04 Oct 2017 Planned primary completion date changed from 2 Jul 2018 to 19 Jan 2018.
    • 05 Jun 2017 Planned End Date changed from 1 Apr 2019 to 30 Nov 2018.
    • 05 Jun 2017 Planned primary completion date changed from 1 Aug 2018 to 2 Jul 2018.
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