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Device

Radiosurgery + TTFields for Lung Cancer

Phase 3

Waitlist Available

Led By Manmeet Ahluwalia, MD

Research Sponsored by NovoCure GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1 inoperable brain metastasis or 2- 10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to specific criteria

18 years of age and older

Must not have

Patients who are known to have somatic tumor mutations in specific genes for which targeted agents are available that directly affect the treatment of brain metastasis

Patients with intractable seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a device to treat brain metastases in advanced NSCLC patients, comparing it to the current standard of care.

Who is the study for?

This trial is for adults with a new diagnosis of 1 inoperable brain metastasis or 2-10 brain lesions from NSCLC, confirmed by MRI. Participants must have a life expectancy of at least 3 months, be able to use the NovoTTF-200M device independently or with help, and not be part of other trials involving brain therapy.

What is being tested?

The study compares the effectiveness and safety of using the NovoTTF-200M device alongside standard supportive treatment versus supportive treatment alone for NSCLC patients after radiosurgery for brain metastases.

What are the potential side effects?

Potential side effects may include skin irritation beneath electrode arrays, headaches, malaise due to carrying the device, and possible interference with underlying conditions due to electric fields.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have 1 to 10 brain tumors that cannot be removed by surgery but can be treated with targeted radiation.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has specific gene mutations treatable with targeted drugs for brain metastasis.

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I have seizures that cannot be controlled with medication.

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My cancer has spread to the lining of my brain and spinal cord.

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I do not have severe health issues that could affect my participation in the study.

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I have one treatable brain tumor.

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I have had whole brain radiation therapy for brain metastases.

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My cancer has spread to my brain more than once.

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I have severe swelling in my brain that could lead to dangerous pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Neurocognitive failure-free survival

Time to neurocognitive failure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NovoTTF-200M deviceExperimental Treatment2 Interventions

NovoTTF-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.

Group II: Best Standard of CareActive Control1 Intervention

Patients will undergo SRS alone and be treated with the best known standard of care for Non-Small Cell Lung Cancer metastatic to the brain.

0 / 10Eligibility criteria met