LUNG CANCER: Brain metastases: XRT Device: "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)

Title
NovoCure METIS
Study Title

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)

Site Link
Malignancy
Lung Cancer; NSCLC, non-small cell lung cancer; brain metastases
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
N/A
Investigational Agent
NovoCure TTFields
Drug Class
Device administering alternating electrical fields
PI
Matt Ballo, M.D.
Sponsor
NovoCure Ltd.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • New diagnosis of brain mets from a histologically or cytological confirmed primary or metastatic NSCLC tumor. If original histologic proof of malignancy is >5 years, new pathologic confirmation is needed
  • KPS >70
  • 1 inoperable brain mets or 2-10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to following criteria
    • Largest tumor volume < 10cc
    • Longest tumor diameter < 3cm
    • Cumulative volume of all tumors < 15cc
  • At least one measurable lesion per RANO-BM
  • May continue on systemic therapy during trial. Should be receiving optimal systemic therapy.
  • Patient must be able to operate NovoTTF-100M device independently or with caregiver
  • No ALK/ROS-1 alterations. No BRAF, EGFR mutations
  • No significant edema with risk of brain herniation
  • No midline shift > 10mm
  • No intractable seizures
  • No infratentorial or leptomeningeal mets
  • No recurrent brain mets or brain mets previously treated with surgery/XRT/radiosurgery
  • No implantable electronic medical devices in the brain
  • No other concurrent brain directed therapy
Objective

- Primary- Time to first cerebral progression; Secondary- Time to neurocognitive failure, radiologic response in the brain, time to second cerebral progression, OS, Intracranial PFS, time to distant progression in supratentorial region, rate of decline in cognitive function, QoL, Safety

Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
Non-small cell lung cancer. EGFR wt, ALK/ROS normal
Dosing Frequency
Control Agents
Radiosurgery alone
Study Protocol
Randomized
Yes
X