E GFR TKI and EGF-P TI C Ombination in EGFR mutA nt NSCL C

Patients will commence daily oral therapy with the EGFR TKI afatinib as soon as possible, preferably on the same day as low dose cyclophosphamide. Afatinib will be prescribed according to the Summary of Product Characteristics (SmPC) of the product, and will continue in nominal 21-day cycles for as long as clinically indicated.

"The first day of dosing with EGF-PTI will be designated Day 1. Immunisation with EGF-PTI will commence 3 days after low dose cyclophosphamide and commencement of EGFR TKI, and will be repeated on Day 14, Day 28, Day 43, and Day 92. After the 5~th vaccination, patients will enter a maintenance phase during which reduced dose vaccinations will be performed every 2 or 3 months in conjunction with the interval between detailed check-up of the patient. As this interval can vary between patients, the interval for maintenance vaccination can also vary between 2 and 3 months."

Eligible patients will receive a single pre-treatment of low dose of intravenous cyclophosphamide 200 mg/m2 (Day -3).