Spots Global Cancer Trial Database for Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma

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Trial Identification

Brief Title: Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma

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

Study ID: NCT02863055

Conditions

Malignant Pleural Mesothelioma

Interventions

Nintedanib

Placebo

Study Description

Brief 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.