Radiosurgery + TTFields for Lung Cancer

Recruiting in Palo Alto (17 mi)

+135 other locations

Overseen byManmeet Ahluwalia, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: NovoCure GmbH

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-200M and supportive treatment compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Eligibility Criteria

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.

Inclusion Criteria

8. You can use the NovoTTF-200M device by yourself or with the help of a caregiver. 9. You can have taken part in other clinical trials before, as long as they did not involve treatment specifically targeting the brain.

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

I am on the best treatment for my cancer outside the brain and can continue it while starting TTFields.

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Exclusion Criteria

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

I have seizures that cannot be controlled with medication.

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

See 6 more

Treatment Details

Interventions

NovoTTF-100M device (Device)
NovoTTF-200M device (Device)

Trial OverviewThe 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.

Participant Groups

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.