drugset / Trial / NCT00447057
Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 150 mg | Oral |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |