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
Price :
$35
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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
- 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.