NCT02863055

Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma

Nintedanib as Maintenance Treatment of Pleural Malignant Mesothelioma (NEMO): a Randomized Double Blinded Phase II Study of the EORTC Lung Cancer Group

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, 1:1, double blinded phase II trial. Patients with unresectable malignant pleural mesothelioma (MPM) will be randomized between arm A: nintedanib and arm B:placebo

Detailed description

This is a multicenter, prospective, double blinded, randomized, two-arm phase II trial aiming to evaluate nintedanib treatment as switch maintenance in patients with unresectable MPM. After signing of the informed consent and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to: * Arm A: twice daily nintedanib at a dose of 200 mg until progression or unacceptable toxicities. * Arm B: matched placebo. Response evaluation will be performed through CT scans every 8 weeks.

Conditions

• Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
DRUG	Nintedanib	Nintedanib 200 mg administered twice daily
DRUG	Placebo	Matching placebo administered twice daily

Timeline

• Start date: 2018-02-04
• Primary completion: 2023-10-12
• Completion: 2024-01-10
• First posted: 2016-08-11
• Last updated: 2025-09-19

Locations

9 sites across 3 countries: Belgium, Italy, United Kingdom