This adjuvant trial will compare the effectiveness of Tykerb, also known as lapatinib, versus placebo given in high-risk patients following surgery.
The design of this phase III trial was based on recent results from two studies that demonstrated the new standard of care in the post-operative treatment of high-risk squamous cell carcinoma head and neck (SCCHN) patients with additional use of chemotherapy.
This phase III study will enroll high-risk patients with locally advanced head and neck cancer that have undergone surgery. The principal objective will be to investigate the length of time without disease symptoms, and overall survival with other clinical factors will also be measured.
“Having already shown promise as a breast cancer treatment, we are very excited to continue investigating lapatinib in SCCHN,” said Paolo Paoletti, senior vice president, Oncology Medicine Development Centre, GSK.
“Lapatinib may represent a new treatment approach to difficult-to-treat tumor types, such as head and neck cancer, offering hope to patients in need of a further treatment option.”