MedTrace Logo

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).

NCT02831959 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2025-10-31

No results posted yet for this study

Summary

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.

Conditions

  • Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Interventions

DEVICE

NovoTTF-200M device

OTHER

Best Standard of Care

Sponsors & Collaborators

  • NovoCure GmbH

    lead INDUSTRY

Principal Investigators

  • Minesh Mehta, MD · Miami Cancer Institute, Miami FL USA

  • Paul Brown, MD · MD Anderson Cancer Center, Houston TX USA

  • Vinai Gondi, MD · Northwestern Medicine Cancer Center, Warenville IL USA

  • Manmeet Ahluwalia, MD · Cleveland Clinic, Cleveland OH USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2024-11-29
Completion
2024-11-29
FDA Device
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Canada
  • China
  • Croatia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Poland
  • Serbia
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02831959 on ClinicalTrials.gov