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A. Mellemgaard



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    Poster Display Session (ID 63)

    • Event: ELCC 2017
    • Type: Poster Display Session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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      139TiP - A non-interventional biomarker study in patients (pts) with non-small cell lung cancer (NSCLC) of adenocarcinoma histology who are treated with nintedanib according to the approved label (LUME-BioNIS) (ID 260)

      12:30 - 13:00  |  Author(s): A. Mellemgaard

      • Abstract

      Background:
      Nintedanib+docetaxel significantly improved overall survival (OS) of pts with advanced adenocarcinoma NSCLC. There are currently no validated tumour- or serum-derived biomarkers to predict the efficacy of antiangiogenic therapy. The objective of this study is to investigate whether tumour-based gene/protein expression patterns or genomic markers, alone or combined with clinical covariates, could predict treatment effect in pts with adenocarcinoma NSCLC receiving nintedanib (Vargatef[®]).

      Trial design:
      In this non-interventional study at 86 mainly European sites, new biomarker data and clinical characteristics will be collected from ∼300 pts who receive nintedanib as part of routine treatment. Pts must be eligible for nintedanib+docetaxel, i.e. have advanced adenocarcinoma NSCLC after first-line chemotherapy, and will receive nintedanib 200 mg twice daily (Days 2–21 of 21-day cycle) and docetaxel (75 mg/m[2]; Day 1). The primary outcome is OS in relation to exploratory biomarker assessment, including gene expression profile, tumour genomic alterations and protein analysis. Tumour tissue samples obtained prior to first-line therapy are required along with informed consent. Mutation analysis of nintedanib target genes (VEGFR1–3, FGFR1–3, PDGFR α/β) and driver genes (EGFR, KRAS, ALK, BRAF, PIK3CA) will be conducted, as well as evaluation of tumour protein expression (e.g. PD-L1, CD133) and proliferation (Ki-67) markers by immunohistochemistry. One ∼2 mL blood sample (or a buccal swab) will be collected at baseline or after nintedanib initiation alongside routine blood sampling to analyse the potential influence of genetic variants in angiogenesis-related genes (e.g. single nucleotide polymorphisms in VEGFR1). Pts will be followed up every 6 months. The primary outcome will be analysed after 250 deaths. Gene expression patterns and tumour genomics in relation to efficacy will be analysed using univariate and multivariate regression models. Adverse events will be assessed. All analyses will be exploratory and considered hypothesis-generating. The study is ongoing (NCT02671422).

      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. K. Kerr: Personal fees from Boehringer Ingelheim, during the conduct of the study. All other authors have declared no conflicts of interest.