Electric field device shows promise for lung cancer brain spread

NCT ID NCT02831959

Disease control Sponsor: NovoCure GmbH Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a portable device that creates low-intensity electric fields (called Tumor Treating Fields, or TTFields) can help control brain tumors that have spread from non-small cell lung cancer. 298 adults with 1 to 10 brain metastases received standard radiosurgery and were then randomly assigned to use the TTFields device plus supportive care, or supportive care alone. The goal was to see if the device could delay tumor growth in the brain and help preserve memory and thinking skills.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Tumor Treating Fields (TTFields) delivered via a portable, battery-operated device (NovoTTF-200M)
What this could lead to: If successful, this could offer a new way to delay brain tumor progression and protect thinking abilities in people with lung cancer that has spread to the brain.
What could go wrong: This is a completed Phase 3 trial, but results are not yet widely known. The device requires wearing electrode arrays on the scalp, which may cause skin irritation or be inconvenient. It may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

298 people

The number who actually took part.

Start date

Jul 2016

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 greater than 5 years, then pathological confirmation is required (i.e.: from extra-cranial or intracranial disease). 5\. 1 inoperable brain metastasis or 2- 10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to the following criteria: a. largest tumor volume \< 10 cc b. longest tumor diameter \< 3 cm c. Cumulative volume of all tumors ≤ 15 cc 6. At least one measurable disease per study protocol 7. Patients must be receiving optimal therapy for their extracranial disease according to local practice at each center. Patients may continue on systemic therapy while receiving TTFields. 8\. Able to operate the NovoTTF-200M device independently or with the help of a caregiver 9. Clinical trials prior to enrollment are allowed, as long as no brain directed therapy was included (current treatment trials are exclusionary) Exclusion Criteria: 1. Patients who are known to have somatic tumor mutations in the following genes, for which targeted agents are available that directly affect the treatment of brain metastasis: Anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), ROS-1 proto- oncogene, and proto-oncogene B-RAF 2. Patients who have a single, operable brain metastasis 3. Patients with significant edema leading to risk of brain herniation 4. Patients with midline shift \> 10mm 5. Patients with intractable seizures 6. Leptomeningeal metastases 7. Recurrent brain metastases 8. Prior WBRT for newly diagnosed brain metastases 9. Severe comorbidities: 1. Clinically-significant inadequate hematological, hepatic and renal function, defined as: Neutrophil count \< 1.5 x 10 9/L and platelet count \< 100 x 10\^9/L; bilirubin \> 1.5 x upper limit of normal (ULN); aspartate transaminase (AST) and/or alanine aminotransferase (ALT) \> 2.5 x ULN or \> 5 x ULN if patient has documented liver metastases; and serum creatinine \> 1.5 x ULN 2. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/ third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea). 3. History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the study. 4. History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable 5. Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy 6. History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent 10. Implantable electronic medical devices in the brain 11. Known allergies to medical adhesives or hydrogel 12. Currently pregnant or breastfeeding 13. Planned concurrent brain directed therapy (beyond SRS and NovoTTF-200M as per protocol)

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Conditions

The condition(s) this trial relates to.

brain cancer metastatic malignant neoplasm in the brain non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain metastases from non-small cell lung cancer (NSCLC)

Contacts and locations

Locations

(CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie

Sherbrooke, Quebec, J1H 5N4, Canada
A.O.S.G. Moscati Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità

Avellino, 83100, Italy
A.O.U Città della Salute e della Scienza di Torino

Torino, 10126, Italy
Abbott Northwestern Hospital - Givens Brain Tumor Center

Minneapolis, Minnesota, 55407, United States
Adult Oncology Research

Orlando, Florida, 32806, United States
Aurora Research Institute

Milwaukee, Wisconsin, 53215-5221, United States
Azienda Socio Sanitaria Territoriale di Lecco

Lecco, Italy
BRCR Medical Center INC

Plantation, Florida, 33324, United States
Banner MD Anderson Cancer Center - McKee Medical Center

Loveland, Colorado, 805838, United States
Banner North Colorado Medical Center (NCMC) - Oncology - Greeley

Greeley, Colorado, 80631, United States
Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States
Barrow Neurological Institute

Phoenix, Arizona, 85013-4407, United States
Baylor Scott & White Medical Center - Temple

Waco, Texas, 76712-8897, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
CDH-Delnor Health System

Warrenville, Illinois, 60555, United States
Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Chaoyang, 100023, China
Cancercare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada
Catalan Institute of Oncology

Barcelona, Spain
Center for Neuro-oncology, Neurosurgery Clinic, Clinical Center of Serbia

Belgrade, 11000, Serbia
Centre Hospitalier Universitaire de Saint-Étienne

Saint-Etienne, 42055, France
Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2L 4M1, Canada
Clairval Hospital Center

Marseille, 13009, France
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Clinica Universidad de Navarra

Pamplona, Spain
Dignity Health - Mercy Cancer Centers

Sacramento, California, 95816, United States
Dr. Senckenbergisches Institut for Neurooncology,

Frankfurt am Main, 60528, Germany
Dr. Senckenbergisches Institut für Neuroonkologie, Zentrum der Neurologie und Neurochirurgie

Frankfurt am Main, 60528, Germany
Ellis Fischel Cancer Center, University of Missouri Healthcare

Columbia, Missouri, 65212, United States
Erlanger Baroness Hospital

Chattanooga, Tennessee, 37403, United States
First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710063, China
Fudan University Shanghai Cancer Center

Shanghai, Xuhui District, China
Gamma Knife Center Warsaw

Warsaw, 03-242, Poland
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
General Hospital Gavazzeni

Bergamo, 24125, Italy
Geza Hetenyi Hospital-Clinic of Jasz-Nagykun-Szolnok County

Szolnok, 5000, Hungary
Grandview Medical Center - Cancer Center

Birmingham, Alabama, 35243-3326, United States
Hadassah Medical Organization

Jerusalem, 91120, Israel
Heidelberg University Clinic for Radiooncology and Radiation Therapy

Heidelberg, 69120, Germany
Hopital Pitié-Salpétriere

Paris, 75013, France
Hospital Universitario HM Sanchinarro Edificio CIOCC

Madrid, 28050, Spain
Houston Methodist Hospital

Houston, Texas, 77030, United States
Hubei Cancer Hospital

Wuhan, Hubei, China
Infirmary Cancer Care

Mobile, Alabama, 36607, United States
Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada
John Nasseff Neuroscience Institute ANW Brain Tumor Center

Minneapolis, Minnesota, 55407, United States
Kaiser Permanente - Sacramento

Sacramento, California, 95825, United States
Kaiser Permanente Redwood City

Redwood City, California, 94063, United States
Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Klinik für Radioonkologie und Strahlentherapie der Charité Universitätsmedizin Berlin Campus Charité Virchow-Klinikum

Berlin, 13353, Germany
Le CIUSSS de I'Est-de-L'ile de Montreal - Hôpital Maisonneuve Rosemont

Montreal, Quebec, H1T-2M4, Canada
Liaoning Cancer Hospital

Shenyang, Liaoning, 110042, China
MD Anderson Cancer Center at Cooper

Camden, New Jersey, 08103, United States
MS Clinsearch Sp. z.o.o.

Lublin, 20-064, Poland
Marek Harat Private Practice, Neurosurgery and Radiation Oncology

Bydgoszcz, 85357, Poland
Maria Sklodowska-Curie National Research Institute of Oncology

Gliwice, 44-101, Poland
Mayo Clinic

Jacksonville, Florida, 32224, United States
Mayo Clinic Phoenix

Phoenix, Arizona, 85054, United States
Medical University of South Carolina- Hollings Cancer Center

Charleston, South Carolina, 29425-8900, United States
Medizinische Universität Innsbruck

Innsbruck, 6020, Austria
Memorial Health University Medical Center

Savannah, Georgia, 31404-6220, United States
MemorialCare Cancer Institute

Long Beach, California, 90806, United States
Miami Cancer Institute

Miami, Florida, 33176, United States
Mischer Neuroscience Associates - Texas Medical Center

Houston, Texas, 77030-1536, United States
Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China
National Koranyi Institute of Tb and Pulmonology

Budapest, 1122, Hungary
Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225007, China
Ochsner Health System

New Orleans, Louisiana, 70121, United States
Oncology Research | Mercy Research

St Louis, Missouri, 63141, United States
Onkologiai Osztaly, Balassa Janos Korhaz

Szekszárd, Hungary
Peking University Third Hospital

Beijing, China
Piedmont Brain Tumor Center

Atlanta, Georgia, 30309, United States
Prisma Health - Upstate

Greenville, South Carolina, 29605, United States
Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States
Qilu Hospital of Shandong University

Jinan, Shandong, China
Qingdao Central Hospital

Qingdao, Shandong, China
Queen Mary Hospital

Hong Kong, Hong Kong
Rabin Medical Center

Petah Tikva, 4941492, Israel
Radiochirugia Zagreb

Sveta Nedelja, 10431, Croatia
Radioterapia Oncologica AOU Careggi

Florence, 50134, Italy
Rambam Medical Center

Haifa, 3109601, Israel
Renown Regional Medical Center

Reno, Nevada, 89502, United States
Rhode Island Hospital

Providence, Rhode Island, 02903, United States
Shandong Cancer Hospital

Jinan, Shandong, China
Sharp HealthCare

San Diego, California, 92123, United States
Sheba Medical Center

Ramat Gan, Israel
Sourasky Medical Center

Tel Aviv, Israel
St. Mary's Medical Center - Grand Junction

Grand Junction, Colorado, 81501, United States
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Poznan, Poland
Taizhou Hospital, Zhejiang Province

Zhejiang, Zhejiang, China
Texas Oncology

McKinney, Texas, 75701, United States
Texas Oncology

Plano, Texas, 75093, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

Orange, California, 92868, United States
The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China
The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China
The First Affiliated Hospital of Xiamen University

Xiamen, China
The First Hospital of China Medical University

Shenyang, China
The First Hospital of Jilin University

Changchun, China
The IRCCS Carlo Besta Neurological Institute Foundation

Milan, 20133, Italy
The Second Affiliated Hospital Of Xingtai Medical College

Hebei, China
The University of Hong Kong-Shenzhen Hospital

Shenzhen, China
Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China
Tufts Medical Center

Boston, Massachusetts, 02111, United States
UF Health Cancer Center

Orlando, Florida, 32806, United States
UF Health Jacksonville

Jacksonville, Florida, 32209, United States
UMHAT Sv. Ivan Rilski EAD, Department of Medical Oncology

Sofia, 1431, Bulgaria
UNC - Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
University Clinical Center

Gdansk, Poland
University Hospital Lille

Lille, 59037, France
University Hospital of Messina AOU Policlinico "G. Martino"

Messina, 98125, Italy
University Multiprofile Hospital for Active Treatment Sofiamed, Department of Medical Oncology

Sofia, 1797, Bulgaria
University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35233, United States
University of California

San Francisco, California, 94117, United States
University of Kansas Cancer Center and Medical Pavilion

Kansas City, Kansas, 66160, United States
University of Kentucky HealthCare

Lexington, Kentucky, 40536, United States
University of Louisville-James Graham Brown Cancer Center

Louisville, Kentucky, 40202-5700, United States
University of Maryland

Baltimore, Maryland, 21201, United States
University of Minnesota Medical Center (UMMC) - Fairview - Masonic Cancer Clinic

Minneapolis, Minnesota, 55455-0341, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of Washington Medical Center

Seattle, Washington, 98195, United States
Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany
Universitätsklinikum Halle (Saale), Klinik für Innere Medizin IV, Hämatologie / Onkologie

Halle, 06120, Germany
Vidant Medical Center

Greenville, North Carolina, 27834, United States
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-0001, United States
Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States
West Cancer Center

Germantown, Tennessee, 38138, United States
Willis-Knighton Cancer Center

Shreveport, Louisiana, 71103, United States
Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China
Zigong Fourth People's Hospital

Zigong, Sichuan, China

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