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 the products described within this website 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 each product 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.
This site uses cookies to improve your browsing experience. By using this site, you agree to their use. Cookie Information
LUME BioNIS: a Biomarker Study of Nintedanib in Patients With NSCLC
A non-interventional biomarker study in patients with non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology eligible for treatment with nintedanib* (Vargatef®) plus docetaxel according to the approved label.
Trial CT.gov-Identifier: NCT02671422
Patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma histology after failure of first-line chemotherapy
Nintedanib plus docetaxel is initiated and administered in accordance with the approved label
Available formalin-fixed and paraffin-embedded tumour tissue routinely obtained at diagnosis and/or at re-biopsy prior to first-line treatment initiation
N=300 (estimated)
Primary outcome measure:
Overall survival in relation to exploratory biomarker assessment, including general expression profile, tumour genomic alterations and protein analysis
Estimated Primary Completion Date is November 1, 2021
The LUME-BioNIS trial is a non-interventional biomarker study in patients who are eligible to receive nintedanib plus docetaxel as part of routine treatment and according to the approved label, i.e. have advanced adenocarcinoma NSCLC after failure of first-line chemotherapy. Mutation analysis of nintedanib target genes will be conducted, as well as evaluation of tumour protein expression and proliferation markers by immunohistochemistry. The study is being conducted at 86 mainly European sites and is currently recruiting participants.
Reck M, et al. Ann Oncol 2017;28 (2 Suppl):mdx091.059 (Abstract 139TiP)
Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT02671422 (Accessed: July 2017).
*Nintedanib is approved in the EU under the brand name VARGATEF® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. For the full list of country-specific information please click here. Nintedanib is not approved in other oncology indications.
