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InOncology.com

LUME-BioNIS clinical trial

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

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)

Nintedanib 200 mg + Docetaxel 75 mg/m² Oral twice daily (Days 2–21 of every 3-week cycle) + Intravenous (Day 1)

Endpoints

Primary outcome measure:

Overall survival in relation to exploratory biomarker assessment, including general expression profile, tumour genomic alterations and protein analysis

Results

Estimated Primary Completion Date is November 1, 2021

Trial Status

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.

 

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References

1

Reck M, et al. Ann Oncol 2017;28 (2 Suppl):mdx091.059 (Abstract 139TiP)

2

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.