Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

3255 - Nintedanib plus docetaxel in routine clinical practice: VARGADO - a German prospective non-interventional study (NIS) reflecting routine treatment conditions in an evolving NSCLC treatment landscape


20 Oct 2018


Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research


Christian Grohe


Annals of Oncology (2018) 29 (suppl_8): viii493-viii547. 10.1093/annonc/mdy292


C. Grohe1, I. Zander2, K. Lüdtke-Heckenkamp3, W. Blau4, S. Krüger5, C. Franke6, H. Mueller-Huesmann7, W.M. Brückl8, N. Basara9, D. Ukena10, S. Lang11, J. Atz12, R. Kaiser12

Author affiliations

  • 1 Department Of Pneumology, ELK Berlin, 13125 - Berlin/DE
  • 2 Onkologie, am Raschplatz, Hannover/DE
  • 3 Niels-stensen-clinics, Georgsmarienhuette, 49074 - Osnabrück/DE
  • 4 Department Of Internal Medicine V, University Hospital Giessen, 35392 - Giessen/DE
  • 5 Department For Pulmonology/allergology/sleep Medicine And Respiratory Care, Florence-Nightingale-Hospital, Duesseldorf/DE
  • 6 Facharztzentrum, Sonneberg, 96515 - Sonneberg/DE
  • 7 Klinik Für Hämatologie Und Onkologie, Bruederkrankenhaus St. Josef, 33098 - Paderborn/DE
  • 8 Dept. Of Internal Medicine 3, Klinikum Nürnberg, Universitätsklinik der Paracelsus Medizinischen Privatuniversität, 90419 - Nuremberg/DE
  • 9 Department Of Internal Medicine, Malteser Hospital St. Franziskus, Flensburg/DE
  • 10 Department Of Pneumology, Klinikum Bremen-Ost, Bremen/DE
  • 11 Department Of Respiratory Medicine, SRH Wald-Klinikum Gera, Gera/DE
  • 12 Medical Affairs Oncology, Boehringer Ingelheim Pharma GmbH & Co KG, 55216 - Ingelheim am Rhein/DE

Abstract 3255


Nintedanib is an oral, triple angiokinase inhibitor approved by the EMA and other countries in combination with docetaxel for the treatment of adenocarcinoma NSCLC patients after first-line chemotherapy. Nintedanib plus docetaxel demonstrated significant and clinically meaningful OS benefits in adenocarcinoma patients, which were more pronounced in patients with aggressive or refractory tumors. During the past years the treatment landscape for advanced NSCLC has changed tremendously impacting individual treatment decisions and choice of adequate treatment sequences. Here we present the ongoing NIS VARGADO study design and set up to assess the efficacy and tolerability of nintedanib plus docetaxel in daily clinical routine in Germany.

Trial design

The NIS VARGADO (NCT02392455) is currently recruiting patients. Four hundred patients are planned to be enrolled at one hundred German centers. Adult NSCLC patients with advanced adenocarcinoma who are initiating treatment with nintedanib according to its label as part of routine clinical practice are eligible. The primary endpoint of the study is the one-year overall survival rate after start of therapy with nintedanib and docetaxel. Progression-free survival is one of the key secondary endpoints. Patients with aggressive or refractory tumors will be analyzed in detail with respect to efficacy in this real world setting. Documentation of patients treated with nintedanib plus docetaxel combination following first-line chemotherapy and/or immunotherapy will allow for analyses on treatment sequence. Analysis of tolerability will comprise the assessment of frequency and severity of adverse events. Furthermore, therapy management under routine conditions will be recorded and assessed.

Clinical trial identification


Legal entity responsible for the study

Boehringer Ingelheim Pharma GmbH & Co. KG.


Boehringer Ingelheim Pharma GmbH & Co. KG.

Editorial Acknowledgement


I. Zander: Consultancy: Boehringer Ingelheim. S. Krüger: Honoraria, Advisory boards and lectures: Boehringer Ingelheim. W.M. Brückl: Payments for membership on advisory boards: Boehringer Ingelheim. J. Atz, R. Kaiser: Employee: Boehringer Ingelheim Pharma GmbH & Co KG. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.