Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer

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

This trial aimed to assess efficacy and safety of cetuximab when given in combination with chemotherapy compared with chemotherapy alone in Chinese participants with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) as the first-line treatment.

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of SCCHN
• Recurrent and/or metastatic SCCHN, not suitable for local-regional treatment
• Presence of at least 1 measurable lesion according to RECIST Version 1.1
• Signed written informed consent before any trial-related activities are carried out
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

• Prior systemic chemotherapy, except if given as part of multimodal treatment for locally advanced disease, that was completed within 6 months before randomization
• Surgery (excluding prior biopsy for diagnosis) or irradiation within 4 weeks before trial entry
• Previous treatment with monoclonal antibody or signal transduction inhibitors targeting epidermal growth factor receptor
• Nasopharyngeal carcinoma
• Known central nervous system metastasis and/or leptomeningeal disease
• Medical or psychological condition that would not permit the participant to complete the trial or sign informed consent
• Legal incapacity or limited legal capacity
• Other protocol-defined exclusion criteria could apply