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

被引:60
作者
Eichhorn, Florian [1 ,4 ]
Klotz, Laura, V [1 ,4 ]
Bischoff, Helge [5 ]
Thomas, Michael [4 ,5 ]
Lasitschka, Felix [2 ,4 ]
Winter, Hauke [1 ,4 ]
Hoffmann, Hans [3 ]
Eichhorn, Martin E. [1 ,4 ]
机构
[1] Heidelberg Univ, Dept Thorac Surg, Thoraxklin, Roentgenstr 1, D-69126 Heidelberg, Germany
[2] Heidelberg Univ, Inst Pathol, Heidelberg, Germany
[3] Tech Univ Munich, Div Thorac Surg, Munich, Germany
[4] German Ctr Lung Res DZL, Translat Lung Res Ctr, Heidelberg, Germany
[5] Heidelberg Univ, Dept Thorac Oncol, Thoraxklin, Heidelberg, Germany
关键词
NSCLC; Neoadjuvant immunotherapy; Checkpoint inhibitor; Thoracic surgery; Pembrolizumab; RESPONSE EVALUATION CRITERIA; TNM CLASSIFICATION; CHEMOTHERAPY; GUIDELINES; ADJUVANT; PROPOSALS; MUTATIONS; GROUPINGS; REVISION; THERAPY;
D O I
10.1186/s12885-019-5624-2
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
BackgroundImmunotherapies 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.MethodsThe 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 2cycles of immunotherapy (a 200mg 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.DiscussionThe 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 registrationProspectively, the NEOMUN study has been registered on www.clinicaltrials.gov; NCT03197467 (first post: June 23rd, 2017).
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