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Nintedanib Plus Pemetrexed/Cisplatin vs Placebo Plus Pemetrexed/Cisplatin in First-Line Malignant Pleural 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 CT.gov-Identifier: NCT01907100
Phase III:
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
Primary outcome measure:
Key secondary outcome measure:
Secondary outcome measures:
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.
Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT01907100 (Accessed: July 2017).
Scagliotti GV, et al. Clin Lung Cancer 2017;[Epub ahead of print]. https://doi.org/10.1016/j.cllc.2017.03.010. Accessed: July 2017.
Grosso F, et al. J Thorac Oncol 2017;12(1 Suppl):S329–S330.
Nowak AK, et al. J Clin Oncol 2017;35(Suppl; Abstract 8506).
Grosso F, et al. J Clin Oncol 2017. In press.
* Nintedanib is being investigated in malignant pleural mesothelioma (MPM) and is not approved for this use. The efficacy and safety of nintedanib in MPM have not been established.
