Zentralbl Chir 2025; 150(S 01): S88-S89
DOI: 10.1055/s-0045-1809760
Abstracts
Perioperative Therapie

Neoadjuvant nivolumab plus platinum-based chemotherapy in patients with non-metastatic resectable NSCLC: Interim data from the non-interventional study NENI

Authors

  • M Eichhorn

    1   Thoraxklinik, Universitätsklinikum Heidelberg, Heidelberg, Deutschland

  • M Reiser

    2   PIOH – Praxis Internistische Onkologie und Hämatologie, Köln, Deutschland

  • C Meyer zum Büschenfelde

    3   St. Vincentius-Kliniken Medizinische Klinik 2 Hämatologie, Onkologie, Karlsruhe, Deutschland

  • M Faehling

    4   Klinikum Esslingen Pneumologie, Kardiologie Angiologie, Esslingen, Deutschland

  • S Hammerschmidt

    5   Klinikum Chemnitz Innere Medizin IV Pneumologie, Onko Allergologie, Intensivmedizin, Chemnitz, Deutschland

  • E von der Heyde

    6   Onkologische Schwerpunktpraxis, Hannover, Deutschland

  • P Hoffknecht

    7   Niels-Stensen-Kliniken Franziskus-Hospital Harderberg Thoraxonkologie, Georgsmarienhütte, Deutschland

  • M Möller

    8   Martha-Maria Krankenhaus Halle-Dölau Innere Medizin II Pneumologie/Hämatologie/Onkologie, Halle (Saale), Deutschland

  • P Meyn

    9   Fachkliniken Wangen Lungenzentrum Süd-West, Wangen, Deutschland

  • K Kokowski

    10   Klinikum Bogenhausen Klinik für Pneumologie und Pneumologische Onkologie, München, Deutschland

  • M Metzenmacher

    11   Universitätsmedizin Essen – Innere Klinik (Tumorforschung) und Ruhrlandklinik, Abteilung für Thorakale Onkologie, Essen, Deutschland

  • W Brueckl

    12   Department of Respiratory Medicine, Allergology and Sleep Medicine, Paracelsus Medical University, General Hospital Nuernberg, Nuremberg, Deutschland

  • R Buettner

    13   Medizinische Fakultät Universitätsklinikum Köln, Institut für Pathologie, Köln, Deutschland

  • F Griesinger

    14   Pius Hospital Oldenburg, Klinik für Hämatologie und Onkologie, Universitätsmedizin Oldenburg, Oldenburg, Deutschland

  • T Bluhmki

    15   Bristol-Myers Squibb GmbH & Co. KgaA, München, Deutschland

  • K Dauber

    15   Bristol-Myers Squibb GmbH & Co. KgaA, München, Deutschland

  • D Waldenberger

    15   Bristol-Myers Squibb GmbH & Co. KgaA, München, Deutschland

  • L Hillejan

    16   Niels-Stensen-Kliniken, Klinik für Thoraxchirurgie und thorakale Endoskopie, Ostercappeln, Deutschland
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Background In CheckMate 816, neoadjuvant nivolumab plus platinum-based chemotherapy (NIVO+CT) significantly improved event-free survival (EFS) and pathologic complete response (pCR) vs CT in patients with resectable non-small cell lung cancer (NSCLC). NIVO+CT is approved in the EU as a neoadjuvant therapy for resectable NSCLC at high risk of recurrence (tumors ≥5 cm or node-positive) and tumor programmed cell death ligand 1 (PD-L1) expression ≥1%. The non-interventional study (NIS) NENI (NCT06169956) aims to evaluate this regimen in clinical practice in Germany. Here, we report baseline patient characteristics.

Methods & Materials Enrollment for the open-label, prospective, NIS NENI is ongoing, with 40 sites and 400 patients planned in Germany. Adult patients with non-metastatic resectable NSCLC at high risk of recurrence and PD-L1 ≥1% are eligible if the decision to initiate neoadjuvant NIVO+CT per the approved label has been made. During the planned ≤5-year follow-up phase, assessments will be conducted per routine local clinical practice. The primary endpoint is EFS. Secondary endpoints include patient characteristics, surgery-related outcomes (completeness and extent of resection, surgical approach, number of lymph nodes resected, and length of hospital stay), pCR, tumor response, and safety. Overall survival is an exploratory endpoint.

Results At interim analysis (31-Oct-2024), 53 patients were enrolled (first patient was enrolled in Dec-2023). Median age was 70.5 (range, 53.5–84.2) years; 75.5% of patients were ≥65 years old. Overall, 69.8% of patients were male, 96.2% were current/former smokers, and 49.1% had ECOG PS ≥1. Most patients had non-squamous histology (60.4%), and stage IIIA–B disease at diagnosis (75.5%). About one-third of patients had Charlson Comorbidity Index ≥2; the most common (≥15%) comorbidities included hypertension (52.8%), COPD (39.6%), and hypercholesterolemia (18.9%). The most frequently received type of CT was carboplatin (98.1%). Surgery-related outcomes will be presented.

Conclusion The NIS NENI will help address an unmet need for real-world insights on NIVO+CT in resectable NSCLC. At interim analysis, patient characteristics were reflective of clinical practice.



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Artikel online veröffentlicht:
25. August 2025

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