Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients

Inclusion Criteria: * Any stage not suitable for radical treatment * Either: Confirmed activating EGFR mutation (exons 18-21; e.g. L858R, exon 19 deletions, exon 20 insertions, T790M, list is not exhaustive), and WHO PS 0-3 Or No tissue suitable for EGFR genotyping, failed genotype, or EGFR genotyping unavailable, and NSCLC Adenocarcinoma sub-type, and Eligible smoking history: Never smoker (\<100 cigarettes in lifetime), or Former smoker (stopped \>1year ago and ≤10 pack-years) and WHO PS 0-2 * Unsuitable for or patient declining chemotherapy due to significant co-morbidity * Measurable disease according to RECIST version 1.1 * Adequate haematopoietic, hepatic and renal function defined as follows: Absolute neutrophil count (ANC) ≤1.5 x 109/L and platelet count ≤100 x 109/L * Bilirubin ≤1.5 x ULN, ALT (SGPT) ≤3 x ULN (or ≤ 5 x ULN in cases of liver metastases) * Serum creatinine clearance ≥45 ml/min * Palliative radiotherapy allowed unless to a solitary target lesion * Age 18 or over (no upper age limit) * Written informed consent that is consistent with ICH-GCP guidelines Exclusion Criteria: * Previous treatment with afatinib (BIBW 2992), or any EGFR-directed inhibitor * Any concurrent anticancer systemic therapy * Prior chemotherapy for relapsed and/or metastatic NSCLC * Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and registration * Suitable for radical radiotherapy * Palliative radiotherapy with…