206TiP - METIS: A phase III study of radiosurgery with TTFields for 1–10 brain metastases from NSCLC

Date 15 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session Poster lunch
Topics Surgical oncology
Non-small-cell lung cancer
Therapy
Radiation oncology
Presenter Uri Weinberg
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors U. Weinberg1, O. Farber2, Z. Bomzon2, M. Giladi2, E.D. Kirson2
  • 1Research & Development, Novocure GmbH, 6039 - Root/CH
  • 2R&d, Novocure Ltd., 30004 - Haifa/IL

Abstract

Background

Tumor Treating Fields (TTFields) is a novel, non-invasive regional anti-mitotic treatment modality, based on low intensity alternating electric fields. Efficacy of TTFields in non-small cell lung cancer (NSCLC) has been demonstrated in multiple in vitro and in vivo models, and in a phase I/II clinical study. TTFields treatment to the brain was shown to be safe and effective in glioblastoma patients.

Trial design

240 patients with 1–10 BM from NSCLC will be randomized in a ratio of 1:1 to receive SRS followed by either TTFields or supportive care alone. Patients are followed-up bimonthly until 2nd intracerebral progression. Patients in the control arm may cross over to receive TTFields at the time of 1st intracerebral progression. Objectives: To test the efficacy, safety and neurocognitive outcomes of TTFields in this patient population. Endpoints: Time to intracerebral progression (primary); time to first/second intracerebral progression for patients with 1–4 and 5–10 BM; 2, 4, 6, 8, 10, 12-month first/second intracerebral progression rate; intracerebral progression free survival; overall survival; time to neurocognitive failure; radiological response; safety (secondary). Treatment: Continuous TTFields at 150 kHz will be applied to the brain within 7 days of SRS. The System is a portable medical device allowing normal daily life activities. The device delivers alternating electric fields to the brain using 4 Transducer Arrays, which may be covered by a wig or a hat for cosmetic reasons. Patients will receive the best standard of care for their systemic disease. Statistical Considerations: This is a prospective, randomized, multicenter study for 240 patients. The trial is designed to detect an increase in the time to intracerebral progression from 7.7 to 13.4 months (hazard ratio 0.57). This sample size assessment takes into consideration a competing risk (death prior to intracerebral progression) of 0.08252 per month in both treatment arms. The competing risk is based on a predicted median overall survival of 8.4 months mainly due to systemic disease progression. The trial has 80% power at a two sided alpha of 0.05. The sample size was calculated using a log-rank test (based on Lakatos 1988 and 2002).

Clinical trial identification

not assigned yet

Legal entity responsible for the study

Novocure Ltd.

Funding

Novocure Ltd.

Disclosure

U. Weinberg, O. Farber, Z. Bomzon, M. Giladi, E.D. Kirson: Novocure employee.