215TiP - STELLAR – A phase II trial of TTFields with chemotherapy for first line treatment of malignant mesothelioma

Date 15 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session Poster lunch
Topics Cytotoxic agents
Mesothelioma
Translational Research
Surgical oncology
Basic Principles in the Management and Treatment (of cancer)
Therapy
Biological therapy
Radiation oncology
Presenter Federica Grosso
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors F. Grosso1, J. Mądrzak2, L. Crinò3, A. Chella4, U. Weinberg5, G.L. Ceresoli6
  • 1Oncologia Medica, Presidio Ospedaliero Civile SS. Antonio e Biagio, 15100 - Alessandria/IT
  • 2Oncology, Medical University of Gdansk, 80210 - Gdansk/PL
  • 3Oncologia Medica, Ospedale S. Maria della Misericordia, 06156 - Perugia/IT
  • 4Pneumo-oncologia, Azienda Ospedaliero Universitaria Pisana, 56124 - Cisanello/IT
  • 5Research & Development, Novocure GmbH, 6039 - Root/CH
  • 6Thoracic & Gu Oncology, Humanitas Gavazzeni, 24125 - Bergamo/IT

Abstract

Background

Tumor Treating Fields (TTFields) are an anti-mitotic, regional treatment modality, which is based on low intensity alternating electric fields delivered non-invasively using a portable, home use, medical device. In-vitro, human mesothelioma cells were found to be highly susceptible to TTFields.

Trial design

Eighty (80) patients with unresectable, previously untreated MPM will be treated with pemetrexed and cisplatin or carboplatin in combination with TTFields. The patients are followed up every 3 weeks (CT scan every 6 weeks) until disease progression. Objectives: To test the efficacy and safety of TTFields combined with standard chemotherapy in this patient population. Endpoints: The primary endpoint is overall survival (OS) and secondary endpoints are response rate, progression free survival and treatment-emergent toxicity. Statistical Considerations: This is a prospective phase II, single arm, multicenter study for 80 patients. The historical control is assumed to have an exponential distribution with a constant hazard rate of 0.039 calculated from the median survival of 12.1 Months reported by Vogelzang et al. The sample size provides 80% power with a two sided alpha of 0.05 to detect an increase of 5.5 months in OS which is equivalent to a Hazard Ratio of 0.67 compared to the historical control data for OS. Major Eligibility Criteria: Patients are 18 years of age or older with good performance status (ECOG 0–1). The patients must have pathological or histological evidence of MPM with at least one measurable or evaluable lesion according to modified RECIST criteria. The disease should be previously untreated and not amendable for curative treatment (surgery or radiotherapy). Untreated brain metastases and contraindications to any of the study treatments are exclusionary. Treatment: Continuous TTFields at 150 kHz is applied to the thorax. The System is a portable medical device allowing normal daily life activities. The device delivers alternating electric fields to the thorax using 4 Transducer Arrays. The experimental treatment is administered on top of the standard of care chemotherapy – pemetrexed/platinum doublet.

Clinical trial identification

NCT02397928

Legal entity responsible for the study

Novocure Ltd.

Funding

Novocure Ltd.

Disclosure

U. Weinberg: Novocure employee. All other authors have declared no conflicts of interest.