eprintid: 26398
rev_number: 13
eprint_status: archive
userid: 1589
dir: disk0/00/02/63/98
datestamp: 2019-07-24 13:58:10
lastmod: 2019-08-12 11:34:26
status_changed: 2019-07-24 13:58:10
type: article
metadata_visibility: show
creators_name: Eichhorn, Florian
creators_name: Klotz, Laura V.
creators_name: Bischoff, Helge
creators_name: Thomas, Michael
creators_name: Lasitschka, Felix
creators_name: Winter, Hauke
creators_name: Hoffmann, Hans
creators_name: Eichhorn, Martin E.
title: Neoadjuvant anti-programmed Death-1 immunotherapy by Pembrolizumab in resectable nodal positive stage II/IIIa non-small-cell lung cancer (NSCLC): the NEOMUN trial
subjects: 610
divisions: 912000
divisions: 942000
keywords: NSCLC, Neoadjuvant immunotherapy, Checkpoint inhibitor, Thoracic surgery, Pembrolizumab
abstract: Abstract  Background Immunotherapies targeting the PD1/PD-L1 pathway have had a large impact on the treatment of advanced NSCLC. Concerning multimodality tumor therapy, only few trials until today have been performed investigating neoadjuvant treatment with anti PD-1 immunotherapy prior to curative intent surgery. Aim of the NEOMUN investigator initiated trial (EudraCT-Number: 2017–000105-20; ClinicalTrials.gov  Identifier: NCT03197467) is to assess feasibility and safety of pre-surgical anti PD-1 treatment in order to improve long term survival.   Methods The study is designed as an open-label, single arm, prospective, monocenter, phase II study including 30 patients with NSCLC stage II/IIIA suitable for curative intent surgery. Investigational drug is Pembrolizumab. After 2 cycles of immunotherapy (à 200 mg q3w i.v.), tumor resection with lobectomy or bilobectomy will be performed. Primary objectives are to assess the feasibility and safety of a neoadjuvant immunotherapy and to assess antitumor activity of Pembrolizumab with regard to clinical and pathological tumor response. Secondary objective is disease free and overall survival. Exploratory objective is to analyze potential predictive biomarkers and to evaluate the therapeutic efficacy of Pembrolizumab by extended immune cell and cytokine analysis of tumor tissue. The study protocol was approved by the local ethics committee and the federal authority. Start of patient enrollment is scheduled for June 2018.   Discussion The NEOMUN trial will be one of the first clinical trials investigating a multimodal treatment strategy including neoadjuvant immunotherapy using Pembrolizumab as an investigational drug. Assessing the safety and therapeutic potential of neoadjuvant immunotherapy in connection with lung surgery will be of great interest for thoracic surgeons.   Trial registration Prospectively, the NEOMUN study has been registered on www.clinicaltrials.gov  ; NCT03197467 (first post: June 23rd, 2017).
date: 2019
publisher: BioMed Central ; Springer
id_scheme: DOI
ppn_swb: 1671184777
own_urn: urn:nbn:de:bsz:16-heidok-263980
language: eng
bibsort: EICHHORNFLNEOADJUVAN2019
full_text_status: public
publication: BMC Cancer
volume: 19
number: 413
place_of_pub: London ; Berlin, Heidelberg
pagerange: 1-8
issn: 1471-2407
citation:   Eichhorn, Florian ; Klotz, Laura V. ; Bischoff, Helge ; Thomas, Michael ; Lasitschka, Felix ; Winter, Hauke ; Hoffmann, Hans ; Eichhorn, Martin E.  (2019) Neoadjuvant anti-programmed Death-1 immunotherapy by Pembrolizumab in resectable nodal positive stage II/IIIa non-small-cell lung cancer (NSCLC): the NEOMUN trial.  BMC Cancer, 19 (413).  pp. 1-8.  ISSN 1471-2407     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/26398/1/12885_2019_Article_5624.pdf