CLRM-10 METIS (EF-25): A PIVOTAL, RANDOMIZED CONTROLLED STUDY OF TUMOR TREATING FIELDS IN PATIENTS WITH 1–10 BRAIN METASTASES FROM NON-SMALL CELL LUNG CANCER

ABSTRACT: Abstract

BACKGROUND

Tumor Treating Fields (TTFields) are electric fields that disrupt cancer cell division. TTFields treatment showed efficacy in preclinical non-small cell lung cancer (NSCLC) models. Furthermore, TTFields therapy improved survival with a tolerable safety profile in patients with glioblastoma. The objective of the pivotal METIS trial [NCT02831959] is to evaluate the efficacy and safety of TTFields therapy in NSCLC patients with brain metastases.

METHODS

NSCLC patients (N=270) with 1–10 brain metastases will be randomized 1:1 to stereotactic radiosurgery (SRS) followed by continuous TTFields therapy using NovoTTF-200M (150 kHz, recommended >18 h/day) with best standard of care (BSC) or SRS followed by BSC alone. Follow-ups will be conducted every 2 months

SUBMITTER:  

PROVIDER: S-EPMC9354224 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature