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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

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment298

FDA Designations

No designations recorded

Clinical trial landscape

NovoTTF-200M device, Best Standard of Care · 1 trial · 1 indication

Phase 3 1
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).Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
COMPLETED298 Analytics
PHASE3COMPLETED
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).
Brain Metastases From Non-small Cell Lung Cancer (NSCLC)Unlock trial analytics

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 to 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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Frequently asked questions about NovoTTF-200M device, Best Standard of Care

What is the NovoTTF-200M device used for in brain metastases from non-small cell lung cancer?

The NovoTTF-200M device is used for the treatment of brain metastases from non-small cell lung cancer (NSCLC). It is being studied as an addition to radiosurgery for patients with 1 to 10 brain metastases. The device delivers tumor treating fields, a form of electric field therapy, to the brain.

What does the NovoTTF-200M device target?

The NovoTTF-200M device targets tumor cells by delivering tumor treating fields (TTFields), which are low-intensity, alternating electric fields that disrupt cancer cell division. This mechanism is being evaluated in brain metastases from non-small cell lung cancer, where the device is used in combination with radiosurgery.

Who makes the NovoTTF-200M device?

The NovoTTF-200M device is developed by NovoCure Limited, a company traded under the ticker NVCR. NovoCure is an oncology company focused on developing tumor treating fields therapy for various solid tumors, including brain metastases from non-small cell lung cancer.

What phase is the NovoTTF-200M device in?

The NovoTTF-200M device is in Phase 3 clinical development. It is an investigational device, not yet approved, and is being evaluated in a completed Phase 3 study for brain metastases from non-small cell lung cancer. The study was a pivotal, open-label, randomized trial.

What clinical trials is the NovoTTF-200M device in?

The NovoTTF-200M device was studied in a single Phase 3 clinical trial with the identifier NCT02831959. This completed trial enrolled 298 participants and evaluated radiosurgery with or without tumor treating fields for 1 to 10 brain metastases from non-small cell lung cancer. The trial was conducted across multiple countries.

Is the NovoTTF-200M device the same as tumor treating fields therapy?

The NovoTTF-200M device is a specific device that delivers tumor treating fields (TTFields) therapy. It is designed to apply alternating electric fields to the brain to treat metastases from non-small cell lung cancer. The device is being tested in combination with radiosurgery in a Phase 3 trial.