ObjectiveTo systematically review the clinical efficacy and safety of afatinib in the treatment of advanced non-small cell lung cancer (NSCLC).MethodsWe electronically searched databases including The Cochrane Library, PubMed, EMbase, CNKI, WanFang Data and VIP to collect randomized controlled trials (RCTs) about the afatinib for advanced non-small cell lung cancer from inception to October 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software. ResultsEight RCTs were included. The results of meta-analysis showed that afatinib could significantly prolonged progression-free survival (PFS) for lung adenocarcinoma patients (HR=0.43, 95%CI 0.32 to 0.57, P<0.000 01), but there was no significant difference between the two groups in terms of overall survival (OS) in patients with lung adenocarcinoma (HR=1.03, 95%CI 0.85 to 1.23, P=0.79). In addition, afatinib significantly increased the patient’s adverse reactions including diarrhea, skin rashes, nausea and vomiting.ConclusionAfatinib can improve PFS in patients with lung adenocarcinoma, but it does not prolong OS. Due to the limited quantity and quality of included studies, the above conclusions are still needed to be verified by more high quality studies.