Patients received oral afatinib once daily (starting dose of 40mg), administered in cycles of 28 days. Dose reductions to 30mg and 20mg afatinib applied according to drug related toxicity.

·         Any stage NSCLC patient not suitable for radical treatment who harbour a suspected EGFR mutation or confirmed EGFR mutation.

·         WHO performance status of 0-3.

·         Adequate renal and liver function, serum creatinine clearance ≥ 45 ml/min.

·         No concurrent anticancer treatment.

·         No pre-existing interstitial lung disease.

·         No significant or recent gastrointestinal abnormalities with diarrhoea as a major symptom.

·         No symptomatic heart failure with NYHA classification of 3 or more.