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NovoTTF-200M device, Best Standard of Care

Phase 3

Brain Metastases From Non-small Cell Lung Cancer (NSCLC) | Unknown | Oncology |NovoCure Limited|Last Updated: Oct 31, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment298
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02831959Pivotal, 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).PHASE3 COMPLETED 298Jul 1, 2016Nov 29, 2024Oct 31, 2025128 United States, Austria +13
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Study Endpoints
Primary Endpoints
Time to intracranial progression
3 years
Secondary Endpoints
Time to neurocognitive failure
3 years
Overall survival
3 years
Radiological response in the brain following study treatments
3 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NovoTTF-200M deviceEXPERIMENTALNovoTTF-200M device Patients undergo SRS followed by continuous TTFields treatment using the NovoTTF-200M device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.
Best Standard of CareACTIVE_COMPARATORPatients will undergo SRS alone and be treated with the best known standard of care for Non-Small Cell Lung Cancer metastatic to the brain.
Interventions
NameTypeDescription
NovoTTF-200M deviceDEVICE -
Best Standard of CareOTHER -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites128

Inclusion Criteria: 1. 18 years of age and older 2. Life expectancy of ≥ 3 months 3. 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 the original histological proof of malignancy is ...

Countries:United StatesAustriaBulgariaCanadaChinaCroatiaFranceGermanyHong KongHungaryIsraelItalyPolandSerbiaSpain
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