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)

Purpose

To obtain information on the safety & effectiveness of the NovoTTF-100M (study device) in patients with brain metastases (tumors) from non-small cell lung cancer.

Criteria

18 years of age and older

Life expectancy of ≥ 3 months

New diagnosis of brain metastases from NSCLC.

Karnofsky performance status ≥ 70

1 inoperable brain metastasis or 2-10 brain lesions

At least 1 measurable lesion

You Cannot:            Have known tumor mutations for which targeted agents are available for the treatment of brain mets.

Have a single, operable brain metastasis

Have significant edema

Have midline shift > 10mm

Have intractable seizures

Have leptomeningeal metastases

Have recurrent brain metastases

Have prior whole brain radiation therapy for newly diagnosed brain metastases

Have severe comorbidities

Details

The total duration for this study is up to 36 months. The study consists of 4 periods: 

Screening Period- within 21 days prior to study entry (enrollment) ·        

Treatment Period- Once all requirements are met for participation in the study, the patient will be assigned to one of the following groups:

1. NovoTTF-100M group

Radiosurgery (SRS) radiation treatment first.

Then begin using the NovoTTF-100M device.

Along with supportive care

2. Supportive care group

Radiosurgery (SRS) radiation treatment first

Then supportive care 

The NovoTTF-100M device will not be used

Post-Treatment Follow-up Period- clinic visit 4 weeks after completion of SRS & then every 8 weeks for follow-up after that.

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Radiation Oncology Services

IRB: Copernicus
IRB Number:
Trial Type: NA
Sponsor: NovoCure