A randomized phase II study of pemetrexed (P) versus pemetrexed-carboplatin (PC) as second line treatment for patients (pts) with advanced non-small-cell lung cancer (NSCLC)- NVALT 7

8050 Background: The role of platinum compounds as part of second line therapies in advanced NSCLC is ill defined. We performed a randomized phase II trial comparing P and PC in pts relapsing after platinum-based chemotherapy. Methods: Main eligibility criteria: histological or cytological proof of advanced NSCLC, relapse > 3 months (mo) after (first-line) platinum-based chemotherapy, normal organ reserve, ECOG PS 0–2, age >18 years and signed informed consent. After stratification, pts were randomized to (A) P 500 mg/m2 i.v. q 3 wks or (B) C AUC 5 and P 500 mg/m2 both iv q 3 wks. Response was assessed 6 weekly according to RECIST and toxicity 3 weekly according to NCI-CTC criteria. The primary endpoint was time to progression (TTP). Secondary endpoints: objective response rate (ORR), overall survival (OS), toxicity. The study was designed to detect a 33% decrease in hazard of progression in the combination arm with 80% power (at α=0.05 two-sided log-rank test). Results: From October 2005 to May 2007 151 ...