AzTrials
AzTrials

Brain Metastases From Non-small Cell Lung Cancer (NSCLC)Phase 3NCT02831959

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).

A Phase 3 study testing NovoTTF-200M device in people with Brain Metastases From Non-small Cell Lung Cancer (NSCLC), run by NovoCure GmbH at 128 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NovoTTF-200M device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
128 sitesin 15 countries
Study dates
Jul 2016to 29 Nov 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age and older
  • Life expectancy of ≥ 3 months
  • 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:
  • 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)

Who cannot join

  • 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
  • Patients who have a single, operable brain metastasis
  • Patients with significant edema leading to risk of brain herniation
  • Patients with midline shift > 10mm
  • Patients with intractable seizures
  • Leptomeningeal metastases
Show all 19Show fewer
  • Recurrent brain metastases
  • Prior WBRT for newly diagnosed brain metastases
  • Severe comorbidities:
  • 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
  • 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).
  • 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.
  • History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable
  • Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy
  • 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
  • Implantable electronic medical devices in the brain
  • Known allergies to medical adhesives or hydrogel
  • Currently pregnant or breastfeeding
  • Planned concurrent brain directed therapy (beyond SRS and NovoTTF-200M as per protocol)

Trial locations and contacts

128 sites in 15 countries.

128 sites in 15 countries

United States61 sites

  • Piedmont Brain Tumor Center

    Atlanta, Georgia, 30309

  • University of Maryland

    Baltimore, Maryland, 21201

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20814

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35233

  • Grandview Medical Center - Cancer Center

    Birmingham, Alabama, 35243-3326

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

  • UNC - Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina- Hollings Cancer Center

    Charleston, South Carolina, 29425-8900

  • Erlanger Baroness Hospital

    Chattanooga, Tennessee, 37403

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ellis Fischel Cancer Center, University of Missouri Healthcare

    Columbia, Missouri, 65212

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • West Cancer Center

    Germantown, Tennessee, 38138

  • St. Mary's Medical Center - Grand Junction

    Grand Junction, Colorado, 81501

  • Banner North Colorado Medical Center (NCMC) - Oncology - Greeley

    Greeley, Colorado, 80631

  • Vidant Medical Center

    Greenville, North Carolina, 27834

  • Prisma Health - Upstate

    Greenville, South Carolina, 29605

  • Mischer Neuroscience Associates - Texas Medical Center

    Houston, Texas, 77030-1536

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • UF Health Jacksonville

    Jacksonville, Florida, 32209

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Kansas Cancer Center and Medical Pavilion

    Kansas City, Kansas, 66160

  • University of Kentucky HealthCare

    Lexington, Kentucky, 40536

  • MemorialCare Cancer Institute

    Long Beach, California, 90806

  • University of Louisville-James Graham Brown Cancer Center

    Louisville, Kentucky, 40202-5700

  • Banner MD Anderson Cancer Center - McKee Medical Center

    Loveland, Colorado, 805838

  • Texas Oncology

    McKinney, Texas, 75701

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Aurora Research Institute

    Milwaukee, Wisconsin, 53215-5221

  • Abbott Northwestern Hospital - Givens Brain Tumor Center

    Minneapolis, Minnesota, 55407

  • John Nasseff Neuroscience Institute ANW Brain Tumor Center

    Minneapolis, Minnesota, 55407

  • University of Minnesota Medical Center (UMMC) - Fairview - Masonic Cancer Clinic

    Minneapolis, Minnesota, 55455-0341

  • Infirmary Cancer Care

    Mobile, Alabama, 36607

  • Ochsner Health System

    New Orleans, Louisiana, 70121

  • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

    Orange, California, 92868

  • Adult Oncology Research

    Orlando, Florida, 32806

  • UF Health Cancer Center

    Orlando, Florida, 32806

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013-4407

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054

  • Texas Oncology

    Plano, Texas, 75093

  • BRCR Medical Center INC

    Plantation, Florida, 33324

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Kaiser Permanente Redwood City

    Redwood City, California, 94063

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Dignity Health - Mercy Cancer Centers

    Sacramento, California, 95816

  • Kaiser Permanente - Sacramento

    Sacramento, California, 95825

  • Sharp HealthCare

    San Diego, California, 92123

  • University of California

    San Francisco, California, 94117

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404-6220

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Willis-Knighton Cancer Center

    Shreveport, Louisiana, 71103

  • Oncology Research | Mercy Research

    St Louis, Missouri, 63141

  • Baylor Scott & White Medical Center - Temple

    Waco, Texas, 76712-8897

  • CDH-Delnor Health System

    Warrenville, Illinois, 60555

  • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-0001

Other trials in United States

China22 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Chaoyang, 100023

  • Peking University Third Hospital

    Beijing

  • The First Hospital of Jilin University

    Changchun

  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong

  • The Second Affiliated Hospital Of Xingtai Medical College

    Hebei

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Shandong Cancer Hospital

    Jinan, Shandong

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Qingdao Central Hospital

    Qingdao, Shandong

  • Fudan University Shanghai Cancer Center

    Shanghai, Xuhui District

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042

  • The First Hospital of China Medical University

    Shenyang

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710063

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225007

  • Taizhou Hospital, Zhejiang Province

    Zhejiang, Zhejiang

  • Zigong Fourth People's Hospital

    Zigong, Sichuan

Other trials in China

Italy7 sites

  • A.O.S.G. Moscati Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità

    Avellino, 83100

  • General Hospital Gavazzeni

    Bergamo, 24125

  • Radioterapia Oncologica AOU Careggi

    Florence, 50134

  • Azienda Socio Sanitaria Territoriale di Lecco

    Lecco

  • University Hospital of Messina AOU Policlinico "G. Martino"

    Messina, 98125

  • The IRCCS Carlo Besta Neurological Institute Foundation

    Milan, 20133

  • A.O.U Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Germany6 sites

  • Klinik für Radioonkologie und Strahlentherapie der Charité Universitätsmedizin Berlin Campus Charité Virchow-Klinikum

    Berlin, 13353

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Dr. Senckenbergisches Institut for Neurooncology,

    Frankfurt am Main, 60528

  • Dr. Senckenbergisches Institut für Neuroonkologie, Zentrum der Neurologie und Neurochirurgie

    Frankfurt am Main, 60528

  • Universitätsklinikum Halle (Saale), Klinik für Innere Medizin IV, Hämatologie / Onkologie

    Halle, 06120

  • Heidelberg University Clinic for Radiooncology and Radiation Therapy

    Heidelberg, 69120

Other trials in Germany

Poland6 sites

  • Marek Harat Private Practice, Neurosurgery and Radiation Oncology

    Bydgoszcz, 85357

  • University Clinical Center

    Gdansk

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Gliwice, 44-101

  • MS Clinsearch Sp. z.o.o.

    Lublin, 20-064

  • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

    Poznan

  • Gamma Knife Center Warsaw

    Warsaw, 03-242

Other trials in Poland

Canada5 sites

  • Le CIUSSS de I'Est-de-L'ile de Montreal - Hôpital Maisonneuve Rosemont

    Montreal, Quebec, H1T-2M4

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2L 4M1

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

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

    Sherbrooke, Quebec, J1H 5N4

  • Cancercare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Israel5 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Hadassah Medical Organization

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan

  • Sourasky Medical Center

    Tel Aviv

Other trials in Israel

France4 sites

  • University Hospital Lille

    Lille, 59037

  • Clairval Hospital Center

    Marseille, 13009

  • Hopital Pitié-Salpétriere

    Paris, 75013

  • Centre Hospitalier Universitaire de Saint-Étienne

    Saint-Etienne, 42055

Other trials in France

Hungary3 sites

  • National Koranyi Institute of Tb and Pulmonology

    Budapest, 1122

  • Onkologiai Osztaly, Balassa Janos Korhaz

    Szekszárd

  • Geza Hetenyi Hospital-Clinic of Jasz-Nagykun-Szolnok County

    Szolnok, 5000

Other trials in Hungary

Spain3 sites

  • Catalan Institute of Oncology

    Barcelona

  • Hospital Universitario HM Sanchinarro Edificio CIOCC

    Madrid, 28050

  • Clinica Universidad de Navarra

    Pamplona

Other trials in Spain

Bulgaria2 sites

  • UMHAT Sv. Ivan Rilski EAD, Department of Medical Oncology

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Sofiamed, Department of Medical Oncology

    Sofia, 1797

Other trials in Bulgaria

Austria1 site

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

Other trials in Austria

Croatia1 site

  • Radiochirugia Zagreb

    Sveta Nedelja, 10431

Other trials in Croatia

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Serbia1 site

  • Center for Neuro-oncology, Neurosurgery Clinic, Clinical Center of Serbia

    Belgrade, 11000

Other trials in Serbia

About this study

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.

Read the detailed description

PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:

The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro and in vivo NSCLC pre-clinical models both as a single modality treatment and in combination with chemotherapies. TTFields have also shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.

In a pilot study, 42 patients with advanced NSCLC who had tumor progression after at least one line of prior chemotherapy, received pemetrexed together with TTFields (150 kHz) applied to the chest and upper abdomen until disease progression (Pless M., et al., Lung Cancer 2011). Efficacy endpoints were remarkably high compared to historical data for pemetrexed alone.

In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate) (Stupp R., et al., EJC 2012). Finally, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life (Stupp R., et al., JAMA 2015).

Applying TTFields at 150 kHz to the brain for the treatment of 1-5 brain metastasis from NSCLC using the NovoTTF-100M device has been demonstrated to be safe in a pilot study, where patients were randomized after local therapy of their brain metastasis by neurosurgery and/or stereotactic radiosurgery to receive either NovoTTF-100M treatment or supportive care alone. Eighteen (18) patients have been enrolled in the study. There have been no device-related serious adverse events (SAE) reported to date (Brozova H., et al., Neuro Oncol 2016).

DESCRIPTION OF THE TRIAL:

All patients included in this trial are patients with 1-10 brain metastases from NSCLC which are amenable to stereotactic radiosurgery (SRS). In addition, all patients must meet all eligibility criteria.

Eligible patients will be randomly assigned to one of two groups:

  1. Patients undergo SRS followed by TTFields using the NovoTTF-200M System
  2. Patients undergo SRS alone and receive supportive care. Patients in both arms of the study may receive systemic therapy for their NSCLC at the discretion of their treating physician.

Patients will be randomized at a 1:1 ratio. Baseline tests will be performed in patients enrolled in both arms. If assigned to the NovoTTF-200M group, the patients will be treated continuously with the device until second intracranial progression.

On both arms, patients who recur anywhere in the brain will be offered one of the following salvage treatments (according to local practice) including, but not limited to:

  • Surgery
  • Repeat SRS
  • Whole brain radiotherapy (WBRT) Patients on the control arm will be offered to cross over to the NovoTTF-200M arm of the study and receive TTFields with or without salvage therapy for second intracranial progression if the investigator believes it is in the best interest of the patient and patient agrees.

SCIENTIFIC BACKGROUND:

Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field. These forces cause movement and rotation of electrically charged biological building blocks, much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet.

Electric fields can also cause muscles to twitch and if strong enough may heat tissues. TTFields are alternating electric fields of low intensity. This means that they change their direction repetitively many times a second. Since they change direction very rapidly (150 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating.

The breakthrough finding made by Novocure was that finely tuned alternating fields of very low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause electrically- charged cellular components of these cells to change their location within the dividing cell, disrupting their normal function and ultimately leading to cell death.. In addition, cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place. TTFields interfere with the normal orientation of these tiny motors related to other cellular components since they are electrically-charged as well. As a result of these two effects, tumor cell division is slowed, results in cellular death or reverses after continuous exposure to TTFields.

Other cells in the body (normal healthy tissues) are affected much less than cancer cells since they multiply at a much slower rate if at all. In addition TTFields can be directed to a certain part of the body, leaving sensitive areas out of their reach. Finally, the frequency of TTFields applied to each type of cancer is specific and may not damage normally dividing cells in healthy tissues. In conclusion, TTFields hold the promise of serving as a brand new treatment for brain metastases from NSCLC with very few side effects.

Being tested
NovoTTF-200M device, Best Standard of Care
Keywords
Non-Small Cell Lung Cancer, NSCLC, Brain metastases, Treatment, Minimal toxicity, TTFields, TTF, Tumor Treating Fields, Novocure, SRS, Stereotactic radiosurgery
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NovoTTF-200M deviceDevice

  • Best Standard of CareOther

Study groups in NCT02831959
Study groupRoleWhat they receive
NovoTTF-200M deviceExperimentalNovoTTF-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.
Receives: Device: NovoTTF-200M device; Other: Best Standard of Care
Best Standard of CareActive comparatorPatients will undergo SRS alone and be treated with the best known standard of care for Non-Small Cell Lung Cancer metastatic to the brain.
Receives: Other: Best Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to intracranial progression

    Measured: 3 years

Secondary outcomes (12)

  1. Time to neurocognitive failure

    Measured by cognitive decline on a battery of tests: Hopkins Verbal Learning Test (HVLT-R) free recall, delayed recall, and delayed recognition; Controlled Oral Word Association Test (COWAT); and Trail Making Tests (TMT) Parts A and B

    Measured: 3 years

  2. Overall survival

    Measured: 3 years

  3. Radiological response in the brain following study treatments

    Measured: 3 years

  4. Time to second intracranial progression

    Measured: 3 years

  5. Time to intracranial progression, measured from the date of first SRS treatment to intracranial progression (per modified RECIST 1.1 Criteria) or neurological death, whichever occurs first.

    Measured: 3 years

  6. Time to first and second intracranial progression evaluated in two cohorts of patients, 1-4 brain metastases and 5-10 brain metastases.

    Measured: 3 years

  7. Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months after first SRS treatment

    Measured: 3 years

  8. Time to distant progression, as measured from the date of first SRS treatment to a new intracranial lesion

    Measured: 3 years

  9. Rate of decline in cognitive function as measured by HVLT-R free recall, delayed recall and delayed recognition, COWAT and TMT Parts A and B at 2, 4, 6, 8, 10, 12 months follow-up.

    Measured: 3 years

  10. Neurocognitive failure-free survival

    Defined from the date of first SRS treatment to neurocognitive failure (as measured by HVLT-R free recall, delayed recall, and delayed recognition; COWAT; and TMT Parts A and B) or death (whichever occurs first), censored at the last neurocognitive assessment on which the patient was reported alive without neurocognitive failure

    Measured: 3 years

  11. Quality of Life using the EORTC QLQ C30 with BN20 addendum

    Measured: 3 years

  12. Toxicity during NovoTTF-200M treatment based on incidence and severity of treatment emergent adverse events as evaluated using the CTCAE version 4.0

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completion29 Nov 2024
  4. Study completion29 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02831959
Sponsor's protocol ID
EF-25 METIS
Status last verified
Oct 2025
First submitted
8 Jul 2016
Last updated
31 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.

    PubMed 15126372

  • Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

    PubMed 19387848

  • Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

    PubMed 22608262

  • Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.

    PubMed 26658786

  • Giladi M, Weinberg U, Schneiderman RS, Porat Y, Munster M, Voloshin T, Blatt R, Cahal S, Itzhaki A, Onn A, Kirson ED, Palti Y. Alternating electric fields (tumor-treating fields therapy) can improve chemotherapy treatment efficacy in non-small cell lung cancer both in vitro and in vivo. Semin Oncol. 2014 Oct;41 Suppl 6:S35-41. doi: 10.1053/j.seminoncol.2014.09.006. Epub 2014 Sep 8.

    PubMed 25213867

  • Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.

    PubMed 17551011

  • Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

    PubMed 26670971

  • Pless M, Droege C, von Moos R, Salzberg M, Betticher D. A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):445-450. doi: 10.1016/j.lungcan.2013.06.025. Epub 2013 Jul 23.

    PubMed 23891283

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NovoTTF-200M device in people with Brain Metastases From Non-small Cell Lung Cancer (NSCLC), run by NovoCure GmbH at 128 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States, China, Italy, Germany, Poland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to intracranial progression (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02831959, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.

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