TY  - JOUR
CY  - London ; Berlin, Heidelberg
UR  - https://archiv.ub.uni-heidelberg.de/volltextserver/26398/
N2  - 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).
A1  - Eichhorn, Florian
A1  - Klotz, Laura V.
A1  - Bischoff, Helge
A1  - Thomas, Michael
A1  - Lasitschka, Felix
A1  - Winter, Hauke
A1  - Hoffmann, Hans
A1  - Eichhorn, Martin E.
IS  - 413
KW  - NSCLC
KW  -  Neoadjuvant immunotherapy
KW  -  Checkpoint inhibitor
KW  -  Thoracic surgery
KW  -  Pembrolizumab
Y1  - 2019///
SN  - 1471-2407
PB  - BioMed Central ; Springer
EP  - 8
VL  - 19
JF  - BMC Cancer
AV  - public
ID  - heidok26398
TI  - Neoadjuvant anti-programmed Death-1 immunotherapy by Pembrolizumab in resectable nodal positive stage II/IIIa non-small-cell lung cancer (NSCLC): the NEOMUN trial
SP  - 1
ER  -