Klinische Studien

Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer (NEOMUN)


Laufzeit: 18.06.2018 - 08.03.2021
Status: Auswertung
EudraCT-Nummer: NCT03197467
Nummer Ethikantrag: S

Beschreibung der Studie

The study is designed as an open-label, single arm, prospective, monocenter, phase II study of pembrolizumab in a neoadjuvant setting in patients with resectable NSCLC stage II/IIIA suitable for curative intent surgery, taking place in Germany. Planned sample size is N=30.

Investigational drug is Pembrolizumab at fixed dose, given 200 mg q3w i.v. for 2 cycles. After completion of immunotherapy lobectomy/ bilobectomy with curative intent is scheduled.

Primary objectives are to assess feasibility and safety of a neoadjuvant application of pembrolizumab and to assess antitumor activity of pembrolizumab with regard to clinical and pathologic tumor response. Secondary objective is to assess the impact of neoadjuvant pembrolizumab on patient disease free and overall survival. Exploratory objective is o explore potential predictive biomarkers for pembrolizumab efficacy (immune cell imaging).

Indikation/Einschlusskriterien

Personen

Portrait von Priv.-Doz. Dr. med. Martin Eichhorn

Priv.-Doz. Dr. med. Martin Eichhorn


Portrait von Dr. med. Florian Eichhorn

Dr. med. Florian Eichhorn


Kontakt

OA PD Dr. M Eichhorn

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