An international double-blind, randomised, multicentre, placebo-controlled Phase II/III study of nintedanib plus pemetrexed/cisplatin vs placebo plus pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma (MPM)
RECRUITING into Phase III
LUME-Meso – Nintedanib** vs Placebo in Mesothelioma
Patients with unresectable MPM (≥18 years old)
Histologically confirmed epithelioid MPM
Life expectancy ≥3 months
Eastern Cooperative Oncology Group performance score of 0–1
Nintedanib 200 mg
Oral twice daily (Days 2–21)
Chemotherapy: Pemetrexed 500 mg/m2/cisplatin 75 mg/m2
IV (Day 1)
Placebo + Chemotherapy
Primary Outcome Measure:
Key Secondary Outcome Measure:
Secondary Outcome Measures:
Objective response rate
Disease control rate
Health-related quality of life
The LUME-Meso trial, initiated as a Phase II trial in September 2013 was extended in April 2016 to include a Phase III part. This is a global study being conducted across six regions, which is currently recruiting participants.
Scagliotti GV, Gaafar RM, Nowak A, et al. Lume-meso: A double-blind, randomized, phase II/III study of nintedanib (N) + pemetrexed (P)/cisplatin (C) followed by maintenance N versus placebo + P/C followed by maintenance placebo for patients with unresectable malignant pleural mesothelioma (MPM). J Clin Oncol 2016;34(15)Suppl:TPS8574.
Scagliotti GV, Gaafar RM, Nowak A, et al. LUME-MESO: a placebo-controlled Phase II/III study of nintedanib + pemetrexed/cisplatin followed by maintenance nintedanib. iMig2016. (Abstract PP02.32).
(Accessed: June 2016).