LUX-Lung 4: A Phase II Trial of Afatinib in Patients With Advanced Non–Small-Cell Lung Cancer Who Progressed During Prior Treatment With Erlotinib, Gefitinib, or Both

摘要: Purpose New molecular targeted agents are needed for patients with non–small-cell lung cancer (NSCLC) who progress while receiving erlotinib, gefitinib, or both. Afatinib, an oral irreversible ErbB family blocker, has preclinical activity in epidermal growth factor receptor (EGFR [ErbB1]) mutant models EGFR-activating mutations, including T790M. Patients and Methods This was a Japanese single-arm phase II trial conducted stage IIIB to IV pulmonary adenocarcinoma progressed after ≥ 12 weeks of prior erlotinib and/or gefitinib. received afatinib 50 mg per day. The primary end point objective response rate (complete partial response) by independent review. Secondary points included progression-free survival (PFS), overall (OS), safety. Results Of 62 treated patients, 45 (72.6%) were EGFR mutation positive their tumor according local central laboratory analyses. Fifty-one (82.3%) fulfilled the criteria acquire...