Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients

NCT04205552 ↗

Phase 2 Completed 90 enrolled University Hospital, Essen

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to determine the feasibility of four weeks of preoperative immunotherapy with Nivolumab, and Nivolumab plus Relatlimab in patients with early stage or locally advanced non-small cell lung cancer eligible for curative resection.

Timeline

Start: 2020-03-04
Primary completion: 2025-11-27
Completion: 2025-11-27

Outcome

Met primary endpoint

paper The primary study endpoint was the feasibility of surgery within 43 days, which was met by all patients. PMID 38689060 ↗

Publications

Results Schuler M, Cuppens K, Plones T, Wiesweg M, Du Pont B, Hegedus B, Koster J, Mairinger F, Darwiche K, Paschen A, Maes B, Vanbockrijck M, Lahnemann D, Zhao F, Hautzel H, Theegarten D, Hartemink K, Reis H, Baas P, Schramm A, Aigner C. Neoadjuvant nivolumab with or without relatlimab in resectable non-small-cell lung cancer: a randomized phase 2 trial. Nat Med. 2024 Jun;30(6):1602-1611. doi: 10.1038/s41591-024-02965-0. Epub 2024 Apr 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	240 mg	Intravenous
Subject	Relatlimab	Monoclonal antibody	80 mg	Intravenous
Subject	Relatlimab	Monoclonal antibody	240 mg	Intravenous