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
Phase of Trial: Phase III
Latest Information Update: 02 Feb 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
- 25 Jan 2017 Planned End Date changed from 1 Mar 2018 to 1 Apr 2019.
- 25 Jan 2017 Planned primary completion date changed from 1 Oct 2017 to 1 Aug 2018.
- 08 Sep 2015 Status changed from not yet recruiting to recruiting ass per ClinicalTrials.gov record.