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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 May 2022

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At a glance

  • Drugs Cetuximab (Primary) ; Carboplatin; Cisplatin; Fluorouracil
  • Indications Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms CHANGE II; CHANGE2
  • Sponsors Merck KGaA

Most Recent Events

  • 19 Apr 2022 Status changed from active, no longer recruiting to completed.
  • 18 Aug 2021 Primary endpoint (Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC)), has been met as per results published in the European Journal of Cancer.
  • 18 Aug 2021 Results assessing efficacy and safety of a modified chemotherapy regimen (with a reduced dose of both components) and cetuximab versus chemotherapy for the first-line treatment of chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck, published in the European Journal of Cancer.

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