NCT04205552

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

Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients: Defining Optimal Combinations and Determinants of Immunological Response

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC Stage II
• NSCLC, Stage IIIA
• NSCLC, Stage I

Interventions

Type	Name	Description
DRUG	Nivolumab 10 MG/ML Intravenous Solution	Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min
DRUG	Relatlimab 10 MG/ML Intravenous Solution	Neoadjuvant 2 cycles, every two weeks (q2w) Relatlimab 80 mg i.v. over 30 min

Timeline

• Start date: 2020-03-04
• Primary completion: 2025-03-01
• Completion: 2025-06-01
• First posted: 2019-12-19
• Last updated: 2024-05-09

Locations

4 sites across 3 countries: Belgium, Germany, Netherlands