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Poster display session

838 - Investigation of biomarkers in patients with adenocarcinoma of the lung receiving nintedanib according to approved label: non-interventional LUME-BioNIS study

Date

09 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Cancers in Adolescents and Young Adults (AYA);  Translational Research;  Non-Small Cell Lung Cancer

Presenters

Martin Reck

Citation

Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380

Authors

M. Reck1, A.J. Staal-van den Brekel2, A. Mellemgaard3, N. Morsli4, K. Pietzko5, T. Kitzing6, J. Braunger6, K.M. Kerr7

Author affiliations

  • 1 Department Of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), 22927 - Grosshansdorf/DE
  • 2 Department Of Pulmonary Diseases, Twente Hospitals, Almelo/NL
  • 3 Department Of Oncology, Herlev University Hospital, Herlev/DK
  • 4 -, Boehringer Ingelheim France S.A.S., Paris/FR
  • 5 Boehringer Ingelheim Gmbh & Co. Kg, Biberach an der Riss, 88400 - Biberach/DE
  • 6 Boehringer Ingelheim Gmbh & Co. Kg, Biberach an der Riss, Biberach/DE
  • 7 Department Of Pathology, Aberdeen Royal Infirmary, AB25 2ZN - Aberdeen/GB
More

Resources

Abstract 838

Background

In the Phase 3 LUME-Lung 1 trial, the addition of nintedanib to docetaxel significantly improved overall survival (OS) vs docetaxel alone in patients with adenocarcinoma non-small cell lung cancer (NSCLC) treated with one prior line of chemotherapy. No tumour or serum biomarkers are validated to predict nintedanib efficacy in this setting.

Trial design

LUME-BioNIS (NCT02671422) is an ongoing, prospective, European, multicentre, non-interventional study (N≈300) investigating whether tumour-based genomic or proteomic alterations (± clinical covariates) can predict OS in adults with advanced adenocarcinoma NSCLC initiating nintedanib + docetaxel according to the nintedanib label. Tumour tissue obtained before first-line therapy will be used for biomarker analyses. To ensure sample quality and tumour content across all slides, the first, middle and last slides will be haematoxylin/eosin-stained and assessed by a certified pathologist for tumour content, extent of necrosis and immune cell infiltration. Tumour DNA and RNA will be co-isolated from unstained slides (AllPrep® DNA/RNA FFPE Kit) and quantitated with PicoGreen® and RiboGreen® reagents, respectively. Tumour DNA sequencing libraries will be prepared using a capture-based targeted gene panel covering whole exons of NSCLC-related genes (e.g. EGFR, KRAS, ALK, BRAF, PIK3CA, TP53) and nintedanib target genes (VEGFR1–3, FGFR1–3, PDFGR α/β) and analysed by Illumina® next-generation sequencing (NGS). Transcriptomics analyses will be conducted to: (1) complement DNA analyses by providing further information on gene fusions; and (2) enable tumour classification into transcriptional subtypes. Tumour RNA libraries will be prepared and analysed by NGS or, if RNA quantity/quality is insufficient for sequencing, digital gene expression analysis (nCounter® Gene Expression Panels) will be performed. Unstained slides will also be analysed by immunohistochemistry for immune- and proliferation-related protein expression (PD-L1, Ki-67). The primary endpoint is OS, which will be analysed according to biomarker status.

Clinical trial identification

NCT02671422

Legal entity responsible for the study

Boehringer Ingelheim Pharma GmbH & Co. KG

Funding

Boehringer Ingelheim Pharma GmbH & Co. KG

Disclosure

M. Reck: Author reports personal fees from Boehringer-Ingelheim, Hoffmann-La Roche, Lilly, MSD, BMS, AstraZeneca, Celgene, Merck and Pfizer. N. Morsli, K. Pietzko, T. Kitzing, J. Braunger: Author is an employee of Boehringer-Ingelheim. K.M. Kerr: Personal fees from Boehringer Ingelheim, during the conduct of the study. All other authors have declared no conflicts of interest.

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