drugset / Trial / NCT01454934

A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer

NCT01454934

Phase 3 Completed 540 enrolled Eisai Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.

Timeline

Start
2011-12-09
Primary completion
2014-05-30
Completion
2016-05-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Eribulin Small molecule 1.4 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1250 mg/m2 Intravenous
Comparator Pemetrexed Small molecule 500 mg/m2 Intravenous
Comparator Vinorelbine Small molecule 30 mg/m2 Intravenous