NCT01529112

A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral E7080 in Addition to Best Supportive Care (BSC) Versus BSC Alone in Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Who Have Failed at Least Two Systemic Anticancer Regimens

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the overall survival of patients receiving E7080 + Best Supportive Care (BSC) with those receiving placebo + Best Supportive Care.

Detailed description

This double-blind, placebo-controlled, multicenter, randomized Phase II study will consist of a 2-arm design, comparing E7080 + BSC (Arm 1) with placebo + BSC (Arm 2). Participants will be randomized in the ratio of 2:1 to receive either E7080 or placebo in a blinded manner.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Lenvatinib
DRUG	Lenvatinib matched placebo
DRUG	BSC

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-01-21
• Completion: 2015-06-27
• First posted: 2012-02-08
• Last updated: 2017-09-26
• Results posted: 2016-02-18

Locations

50 sites across 7 countries: United States, Belgium, Czechia, Hungary, Italy, South Korea, United Kingdom