Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer (CHANGE2)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Squamous Cell of Head and Neck

Treatments: Drug: 5-fluorouracil; Drug: Cetuximab; Drug: Cisplatin/Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02383966

EMR062202-060

Details and patient eligibility

About

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.

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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243 participants in 2 patient groups

Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil

Experimental group

Treatment:

Drug: Cisplatin/Carboplatin

Drug: 5-fluorouracil

Drug: Cetuximab

Cisplatin/Carboplatin + 5-Flurouracil

Active Comparator group

Treatment:

Drug: Cisplatin/Carboplatin

Drug: 5-fluorouracil