drugset / Trial / NCT00087711

A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

NCT00087711

Phase 3 Completed 1713 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

Timeline

Start
2004-07
Primary completion
2007-01
Completion
2008-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemcitabine Small molecule 1250 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous