METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC)
The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery.
-Life expectancy of ≥ 3 months.
-New diagnosis of brain metastases from a histologically or cytologically confirmed primary or metastatic NSCLC tumor within 5 years of registration on the study (if greater than 5 years, pathological confirmation is required).
-1 inoperable brain metastasis or 2-10 brain lesions per screening MRI, confirmed by contract-enhanced MRI amenable to SRS.
-Patients must be receiving optimal therapy for their extracranial disease according to local practice at each center. Patient may continue on systemic therapy while receiving TTFields.
-Clinial trials prior to enrollment are allowed, as long as no brain directed therapy was included.
-Patients who are known to have somatic tumor mutations in the following genes: anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), ROS-1 proto-oncogene, and proto-oncogene B-RAF.
-Patients with intractable seizures.
-Severe comorbidities such as: clinically-significant inadequate hematological, hepatic and renal functions, history of significant cardiovascular disease, history of arrhythmia that is symptomatic or requires treatment, history of cerebrovascular accident (CVA) within 6 months prior, active infection, or history of any psychiatric condition that might impair patient's ability to understand or comply with requirements or consent.
-Implantable electronic medical devices in the brain.
-Concurrent brain directed therapy (beyond SRS and NovoTTF-100M as per protocol).
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Ricky Chen, M.D.
- Providence St. Vincent Medical Center