ABSTRACT Objectives and methods The aim of this study was to evaluate the efficacy and safety of PEM (500 mg/m2 day 1, q3w)/CBDCA (AUC 6 day 1, q3w) followed by PEM maintenance therapy in chemo-naive patients with non-sq NSCLC. This reports the analysis results using data collected up to 18 months after last patient entered treatment (data cutoff, January 2012). Results The study included 69 men and 40 women (n = 109) with a median age of 63 years. Of the 109 patients, stage IIIB, IV and recurrent disease were observed in 33 (30%), 72 (66%) and 4 (4%) patients, respectively. A total of 75 patients (69%) completed four cycles of the induction phase by PEM/CBDCA combination therapy and 60 patients (55%) moved to the PEM maintenance phase. Relative dose intensities were 88.8% for PEM and 89.5% for CBDCA during the induction phase, and 89.4% for PEM maintenance. The overall response rate and disease control rate were 34.9% and 72.5% for the entire study period (n = 109), and 3.3% and 48.3% for the maintenance phase (n = 60), respectively. Median progression-free survival was 5.6 months after beginning PEM/CBDCA and 3.9 months after beginning PEM maintenance. In the entire study period, the most common toxic effects were anorexia (75%), nausea (74%) and fatigue (68%). Grade 3–4 neutropenia, thrombocytopenia and anemia were 56%, 41% and 29%, respectively. Newly emerged or deteriorated toxic effects during the maintenance phase were rarely observed. There were no treatment-related deaths. Updated study data including overall survival will be reported at the conference. Conclusions PEM/CBDCA followed by PEM maintenance therapy had a manageable safety profile. These results suggested efficacy in these patients with non-sq NSCLC.