Randomized Phase II Study of First-Line Biweekly Gemcitabine and Carboplatin Versus Biweekly Gemcitabine and Carboplatin plus Maintenance Gemcitabine in Elderly Patients with Untreated Non-Small Cell Lung Cancer: LOGIK0801

Abstract

INTERVENTION: 4 cycles of combined chemotherapy with gemcitabine 1000mg/m2 at day1, 15 and carboplatin AUC3 at day1, 15 followed by chemotherapy with gemcitabine 1000mg/m2 at day1, 15 until PD 4 cycles of combined chemotherapy with gemcitabine 1000mg/m2 at day1, 15 and carboplatin AUC3 at day1, 15. CONDITION: elderly patient untreated non‐small cell lung cancer PRIMARY OUTCOME: Progression free survival SECONDARY OUTCOME: Response rate, Quality of life, Adverse events, Overall survival INCLUSION CRITERIA: 1)Chemotherapy‐naive patients with histologically or cytologically confirmed NSCLC 2)Measurable lesion according to the RECIST 3)Stage IIIB not amenable to curative treatment or stage IV 4)Over 70 years of age 5)PS0, 1 6)Apropriate organ function 7)Life expectancy over 3 months 8)Written informed consent