Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.

Phase 2 Completed 42 enrolled Swiss Cancer Institute

NaSingle-groupOpen-labelTreatment

Summary

Aim of this study is to provide the "proof of concept" of efficacy and tolerability of lurbinectedin monotherapy in progressive malignant mesotheliomas.

Timeline

Start: 2017-09-28
Primary completion: 2021-06-11
Completion: 2021-06-11

Outcome

Met primary endpoint

paper At data cut-off PFS12wks was met by 22/42 pts (52.4%; 90% confidence interval (CI): 38.7% to 63.5%; P = 0.015) PMID 32085891 ↗

paper CONCLUSIONS: The primary efficacy endpoint was reached with acceptable toxicity. PMID 32085891 ↗

Publications

Metaxas Y, Fruh M, Eboulet EI, Grosso F, Pless M, Zucali PA, Ceresoli GL, Mark M, Schneider M, Maconi A, Perrino M, Biaggi-Rudolf C, Froesch P, Schmid S, Waibel C, Appenzeller C, Rauch D, von Moos R; Swiss Group for Clinical Cancer Research (SAKK). Lurbinectedin as second- or third-line palliative therapy in malignant pleural mesothelioma: an international, multi-centre, single-arm, phase II trial (SAKK 17/16). Ann Oncol. 2020 Apr;31(4):495-500. doi: 10.1016/j.annonc.2019.12.009. Epub 2020 Jan 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lurbinectedin	Other / unclassified	3.2 mg/m2	Intravenous