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
Measurable disease according to modified Response Evaluation Criteria In Solid Tumours
No prior first-line therapies for MPM
Life expectancy ≥3 months
Eastern Cooperative Oncology Group performance score of 0–1

N = 450

Randomisation 1:1 

  • Nintedanib 200 mg
    Oral twice daily (Days 2–21 of every 3-week cycle)
    +
    Standard chemotherapy with pemetrexed 500 mg/m2 and cisplatin 75 mg/m2
    Intravenous (IV; Day 1)

  • Placebo 200 mg
    Oral twice daily (Days 2–21 of every 3-week cycle)
    +
    Standard chemotherapy with pemetrexed 500 mg/m2 and cisplatin 75 mg/m2
    IV (Day 1)

Endpoints:

Primary outcome measures:
Progression-free survival (PFS)
Key secondary outcome measure:
Overall survival (OS)
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 confirmatory Phase III part. This is a global study being conducted across six regions and is currently recruiting participants. The Phase II results have been reported.

References:

Scagliotti GV, Gaafar R, Nowak A, et al. P2.01: LUME-MeSO: Phase II/III Study of Nintedanib + Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma. J Thorac Oncol 2016;11(10 Suppl):S216.

Grosso F, Steele N, Novello S, et al. OA22.02 Nintedanib plus Pemetrexed/Cisplatin in Patients with MPM: Phase II Findings from the Placebo-Controlled LUME-Meso Trial. J Thorac Oncol 2017;12 (1 Suppl):S329–S330.

Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT01907100 (Accessed: February 2017).

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