Abstract 3255
Background
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
NCT02392455.
Legal entity responsible for the study
Boehringer Ingelheim Pharma GmbH & Co. KG.
Funding
Boehringer Ingelheim Pharma GmbH & Co. KG.
Editorial Acknowledgement
Disclosure
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.