drugset / Trial / NCT01194453

Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer

NCT01194453

Phase 2 Completed 288 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.

Timeline

Start
2009-11
Primary completion
2010-09
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2
Comparator Gemcitabine Small molecule 1000 mg/m2
Subject Pemetrexed Small molecule 500 mg/m2
Background Dexamethasone Small molecule 3.75 mg Oral
Background Vitamin B12 Other / unclassified 1000 ug Other
Background folic acid Other / unclassified 1000 ug Oral