This website is an international information resource intended for international healthcare professionals outside the United States of America (US) and the United Kingdom (UK) who are interested in information about Boehringer Ingelheim oncology.
While the Internet serves a global community, the pharmaceutical industry is subject to country-specific regulatory considerations. This means that compound status or the registration status and approved product labels of Afatinib or Nintedanib may not be the same in different countries.
Information about approved products on this website is derived from the Summary of Product Characteristics (SPC) for Afatinib and Nintedanib in the EU. It is not country-specific and may vary from the approved label in the country where you are located. Please refer to your local Prescribing Information for full details.
By clicking on the link below you are declaring and confirming that you are a healthcare professional outside the United States of America and the United Kingdom and have read and understood this disclaimer.
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
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
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.
Using this link will let you leave a website of Boehringer Ingelheim International GmbH (“BI”) or to a different domain under the control of BI. In the event that the linked site is not under the control of BI but under the control of a third party or an affiliate in the Boehringer Ingelheim group of companies, BI shall not be responsible for the contents, processing of personal data of any linked site or any link contained in a linked site, or any changes or updates to such sites. This link is provided to you only as a convenience, and the inclusion of any link does not imply endorsement by BI of the site.
Do you want to continue ?Continue