Phase II Study of Nimotuzumab (TheraCim-hR3) Concurrent With Cisplatin/Radiotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Epidermal Growth Factor Receptor (EGFR) is overexpressed in Head and Neck Squamous Cell
Carcinoma (HNSCC). EGFR pathway activation is associated with tumor growth, decreased
apoptosis, and increased angiogenesis. These present a putative target for the use of EGFR
inhibitors either in the form of small molecule inhibitors or monoclonal antibodies.
Several studies have been advanced that suggest application of these targeted therapies show
promising responses with little additional toxicity. The addition of EGFR monoclonal
antibodies to radiation results in better response rates and locoregional control compared
to radiation alone. Addition of EGFR monoclonal antibodies compared to chemotherapy alone
also improves the response rates in patients with advanced HNSCC.
Nimotuzumab is a humanized chimeric monoclonal antibody specific to the extracellular domain
of EGFR. Several studies are ongoing and demonstrate promising efficacy of Nimotuzumab as
monotherapy and in combination with radiation in HNSCC, and in combination with
chemoradiation in Nasopharyngeal Carcinoma. This phase II clinical trial examines the
feasibility of EGFR inhibition using Nimotuzumab in combination with concurrent
chemoradiotherapy in locally advanced unresectable HNSCC. Successful and safe incorporation
of an EGFR monoclonal antibody into the concurrent chemoradiation paradigm used to treat
locally advanced HNSCC will represent an important advance in the optimisation of treatment
for this group of patients.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate of locally advanced HNSCC to treatment with Nimotuzumab and concurrent Cisplatin (CDDP) and Radiotherapy (RT).
Wan-Teck Lim, MD
National Cancer Center Singapore
Singapore: Health Sciences Authority