Trial Information

A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)

Cetuximab is an immunoglobulin G1 (IgG1) monoclonal antibody that enhances the effects of
some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping
toxicities with these approaches. This prospective, observational, non-interventional and
multi-centric post marketing surveillance study is being conducted to collect safety
information from subjects with locally advanced or recurrent/metastatic SCCHN treated with
cetuximab based on the locally approved label. Study plans to enroll 200 to 300 subjects,
who are eligible for cetuximab treatment according to the indication in the approved label
of cetuximab by Taiwan Health Authority. Data related to subjects' demographics, relevant
tumor history, and laboratory information (hematology, biochemistry) will be captured and
analyzed descriptively.

OBJECTIVES

Primary objective:

• To obtain safety information on the use of cetuximab in subjects with SCCHN according to
the regulatory approved label and in a regular clinical setting

Secondary objectives:

• To gather clinical efficacy information of the treatment