NCT01907100

Nintedanib (BIBF 1120) in Mesothelioma

LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 545 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.

Conditions

• Mesothelioma

Interventions

Type	Name	Description
DRUG	Nintedanib	triple kinase inhibitor; 200mg starting dose
DRUG	Pemetrexed	backbone chemo
DRUG	Cisplatin	backbone chemo
DRUG	Cisplatin	backbone chemo
DRUG	Pemetrexed	backbone chemo
DRUG	Placebo	Nintedanib matching placebo

Timeline

• Start date: 2013-09-19
• Primary completion: 2018-03-16
• Completion: 2018-08-31
• First posted: 2013-07-24
• Last updated: 2019-03-18
• Results posted: 2019-03-18

Locations

123 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czechia, Denmark, Egypt, France, Germany, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, South Africa, Spain, Sweden, Turkey (Türkiye), United Kingdom