A randomized phase 2 study of maintenance pemetrexed versus docetaxel following pemetrexed plus carboplatin in advanced non-small cell lung cancer

INTERVENTION: Patients were included in the run‐in phase (four cycles of carboplatin plus pemetrexed).The end of the run‐in phase, patients who did not have progressive disease were randomly allocated to pemetrexed. Patients were included in the run‐in phase (four cycles of carboplatin plus pemetrexed).The end of the run‐in phase, patients who did not have progressive disease were randomly allocated to docetaxel. CONDITION: advanced non‐small cell lung cancer PRIMARY OUTCOME: survival without grade 3/4 toxicity SECONDARY OUTCOME: response rate, overall survival, progression free survival, safety INCLUSION CRITERIA: All participants must meet the following criterias 1: Histologically or pathologically proven NSCLC 2: Radiographically measurable lesion 3: Eastern Cooperative Oncology Group (ECOG) performance status of 0‐1 4: Stage 3B/4 NSCLC 5: Age more than 20 years and less than 75 years 6: Neutrophil count: more than 1,500/uL Platelet count: more than 100,000/uL Hemoglobin: more than 9.0 g/dL Aspartate transaminase (AST), alanine transaminase(ALT): 2.5 times the upper limit of normal of the institutional reference range Total bilirubin: less than 1.5mg/dL. PaO2: more than 60 torr Creatinine: less than 1.2mg/dL or a calculated creatinine clearance more than 45 mL/min 7: Life expectancy of more than 12 weeks 8: Written informed consent