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Neoadjuvant anti-programmed Death-1 immunotherapy by Pembrolizumab in resectable nodal positive stage II/IIIa non-small-cell lung cancer (NSCLC): the NEOMUN trial

Eichhorn, Florian ; Klotz, Laura V. ; Bischoff, Helge ; Thomas, Michael ; Lasitschka, Felix ; Winter, Hauke ; Hoffmann, Hans ; Eichhorn, Martin E.

In: BMC Cancer, 19 (2019), Nr. 413. S. 1-8. ISSN 1471-2407

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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).

Dokumententyp: Artikel
Titel der Zeitschrift: BMC Cancer
Band: 19
Nummer: 413
Verlag: BioMed Central ; Springer
Ort der Veröffentlichung: London ; Berlin, Heidelberg
Erstellungsdatum: 24 Jul. 2019 13:58
Erscheinungsjahr: 2019
ISSN: 1471-2407
Seitenbereich: S. 1-8
Institute/Einrichtungen: Medizinische Fakultät Heidelberg und Uniklinikum > Pathologisches Institut
Medizinische Fakultät Heidelberg und Uniklinikum > Thoraxklinik Heidelberg gGmbH
DDC-Sachgruppe: 610 Medizin
Freie Schlagwörter: NSCLC, Neoadjuvant immunotherapy, Checkpoint inhibitor, Thoracic surgery, Pembrolizumab
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