RECRUITING into Phase III

LUME-Meso – Nintedanib** vs Placebo in Mesothelioma

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)

Trial CTgov-Identifier: NCT01907100

Patients:

Patients with unresectable MPM (≥18 years old)
Histologically confirmed epithelioid MPM
Chemotherapy-naïve
Life expectancy ≥3 months
Eastern Cooperative Oncology Group performance score of 0–1

N = 450 (Phase III)

Randomisation 1:1 

  • Nintedanib 200 mg
    Oral twice daily (Days 2–21)
    +
    Chemotherapy: Pemetrexed 500 mg/m2/cisplatin 75 mg/m2
    IV (Day 1)

  • Placebo + Chemotherapy

Endpoints:

Primary Outcome Measure:
Progression-free survival

Key Secondary Outcome Measure:
Overall survival

Secondary Outcome Measures:
Objective response rate
Disease control rate
Health-related quality of life

Trial Status:

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.

References:

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).

Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/study/NCT01907100
(Accessed: June 2016).

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