drugset / Trial / NCT00447057

Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

NCT00447057 ↗

Phase 2 Completed 204 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelPrevention

Summary

This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival \[PFS\], disease control rate, best response rate, time to treatment failure \[TTTF\], overall survival \[OS\] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.

Timeline

Start
2007-03
Primary completion
2010-07
Completion
2011-06

Outcome

Met primary endpoint

registry Pemetrexed (Nonsquamous) vs Pemetrexed + Erlotinib (Nonsquamous); p = 0.0047; Hazard Ratio (HR) 0.63 (95% CI 0.438 to 0.897); Log Rank NCT00447057 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 150 mg Oral
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous