- Age ≥ 18 years
- Diagnosis of histologically confirmed cutaneous SCC stage Tis-T2N0 for which surgical
treatment is considered suitable.
- In case of SCC, patients must present with a minimum of two co-existing AK lesions.
In case of Keratoacanthoma, one lesion of sufficient size (=1cm) is acceptable.
- All included patients must have both FFPE and frozen material available.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ system function
- Subjects who have current active hepatic or biliary disease
- Other non-controlled malignancy
- Clinically significant gastrointestinal abnormalities that may increase the risk for
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 28 days of study treatment.
- Presence of uncontrolled infection
- History of any one or more of the following cardiovascular conditions within the past
6 months:Cardiac angioplasty or stenting;Myocardial infarction;Unstable
angina;Coronary artery bypass graft surgery;Symptomatic peripheral vascular disease;
Class III or IV congestive heart failure, as defined by the New York Heart
- Poorly controlled hypertension
- History of cerebrovascular accident including transient ischemic attack (TIA),
pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6
- Prior exposure to the study drug lapatinib
- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or
presence of any non-healing wound, fracture, or ulcer