Purpose: To devise a prognostic model based on clinical parameters for non-small cell lung cancer (NSCLC) patients treated with erlotinib as a salvage therapy. Patients and Methods: Between July 2006 and September 2008, two hundred fifty-seven metastatic/relapsed NSCLC patients who had been treated with erlotinib as a salvage therapy were analyzed retrospectively. Results: For the 257 patients, the median overall survival (OS) and progression-free survival (PFS) with erlotinib treatment were 12.4 and 2.8 months. Multivariate analysis showed that an ECOG performance status of 2 or more, an elevated serum LDH level, and the absence of skin rash were independent adverse prognostic factors for OS and that the presence of intra-abdominal metastasis, 2 or more prior chemotherapy regimens, and the absence of skin rash were prognostic factors for PFS. Patients were categorized into the following 4 prognosis groups on the basis of each adverse prognostic factor: good, intermediate, poor, and very poor prognosis. The median OS times for the good, intermediate, poor, and very poor prognosis groups were 22.0, 9.3, 5.4, and 2.7 months (p < 0.001) and the median PFS times were 6.5, 3.0, 1.2, and 0.9 months (p < 0.001). Conclusion: This prognostic model based on clinical parameters would be useful to identify patients who might be most likely to benefit from erlotinib therapy in clinical practice. Copyright (C) 2010 S. Karger AG, Basel