AzTrials
AzTrials

Nonsmall Cell Lung CancerPhase 3NCT02973789

Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure (LUNAR)

A Phase 3 study testing NovoTTF-200T and Immune checkpoint inhibitors or docetaxel in people with Nonsmall Cell Lung Cancer and NSCLC, run by NovoCure GmbH at 124 sites in 18 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 aimed to test the efficacy and safety of TTFields, using the NovoTTF-200T device, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Nonsmall Cell Lung Cancer, NSCLC
What is being tested?
NovoTTF-200T and Immune checkpoint inhibitors or docetaxel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
291 participants
Where
124 sitesin 18 countries
Study dates
Dec 2016to 9 Oct 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • 22 years of age and older (some regional variations to inclusion age exist)
  • Life expectancy of ≥ 3 months
  • Histological diagnosis of squamous or non-squamous, inoperable, metastatic NSCLC
  • Diagnosis of radiological progression while on or after first platinum-based systemic therapy administered for advanced or metastatic disease.
  • Patients who received adjuvant or neoadjuvant platinum-based chemotherapy (after surgery and/or radiation therapy) and developed metastatic disease within 6 months of completing therapy are eligible.
  • Patients with metastatic disease more than 6 months after adjuvant or neoadjuvant platinum-based chemotherapy, who also subsequently progressed during or after a platinum- based regimen given to treat the advanced or metastatic disease, are eligible.
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  • Patients should not receive any systemic therapy after platinum failure before enrollment into the study. Maintenance therapy after platinum based therapy and prior to progression is allowed.
  • ECOG Score of 0-2
  • Assigned by the physician to receive either docetaxel or immune checkpoint inhibitor per standard of care regimen
  • Able to operate the NovoTTF-200T device independently or with the help of a caregiver
  • Signed informed consent for the study protocol

Who cannot join

  • Metastases to central nervous system (CNS) with clinical symptoms or evidence of new metastases to CNS during screening. Patients who previously received treatments for the metastases to CNS, are stable and meet the following requirements are allowed to be enrolled:
  • The patients are neurologically returned to baseline (except for residual signs or symptoms related to CNS treatment).
  • No treatment for the metastases to CNS during the screening period (e.g. surgery, radiotherapy, corticosteroid therapy- prednisone > 10 mg/day or equivalent).
  • No progress in CNS lesions as indicated by MRI within 14 days prior to randomization.
  • No meningeal metastasis or spinal cord compression.
  • Patients planned to receive immune checkpoint inhibitor with contra-indications to receive immunotherapy
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  • Patients planned to receive docetaxel with contra-indications to receive docetaxel
  • Severe comorbidities:
  • Clinically significant (as determined by the investigator) hematological, hepatic and renal dysfunction, defined as: Neutrophil count < 1.5 x 10^9/L and platelet count < 100 x 10^9/L; bilirubin > 1.5 x ULN; AST and/or 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 trial
  • History of pericarditis
  • History of interstitial lung disease
  • 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
  • Any other malignancy requiring anti-tumor treatment in the past three years, excluding treated stage I prostate cancer, in situ cervical cancer, in situ breast cancer and non-melanomatous skin cancer
  • Concurrent treatment with other experimental treatments for NSCLC while on the study
  • Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso
  • Known allergies to medical adhesives or hydrogel
  • Pregnancy or breast-feeding (patients with reproductive potential must use effective contraception methods throughout the entire study period, as determined by their investigator/gynecologist)
  • Admitted to an institution by administrative or court order

Trial locations and contacts

124 sites in 18 countries.

124 sites in 18 countries

United States73 sites

  • Summa Health

    Akron, Ohio, 44304

  • Presbyterian Cancer Center

    Albuquerque, New Mexico, 87110

  • Texas Oncology - Amarillo

    Amarillo, Texas, 79106

  • Texas Oncology - Arlington

    Arlington, Texas, 76012

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Overlake Medical Center & Clinics

    Bellevue, Washington, 98004

  • Vita Medical Associates, P.C.

    Bethlehem, Pennsylvania, 18015

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Central Alabama Research

    Birmingham, Alabama, 35209

  • Tufts Medical Center, Division of Hematology and Oncology

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Ironwood Cancer & Research Center

    Chandler, Arizona, 85224

  • Oncology Specialists of Charlotte

    Charlotte, North Carolina, 28204

  • UT/Erlanger Oncology & Hematology

    Chattanooga, Tennessee, 37403

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

  • Christus Health Spohn Ministry

    Corpus Christi, Texas, 78404

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Geisinger Cancer Institute

    Danville, Pennsylvania, 17822

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Associated Neurologists of Southern CT, P.C.

    Fairfield, Connecticut, 06824

  • Clinical Oncology Associates

    Farmington Hills, Michigan, 48336

  • Detroit Clinical Research Center

    Farmington Hills, Michigan, 48336

  • New York-Presbyterian/Queens Radiation Oncology

    Flushing, New York, 11355

  • California Cancer Associates for Research and Excellence, Inc. cCARE

    Fresno, California, 93720

  • St. Joseph Heritage Healthcare

    Fullerton, California, 92835

  • Banner MD Anderson Cancer Center at North Colorado Medical Center

    Greeley, Colorado, 80631

  • Oncology Consultants, P.A.

    Houston, Texas, 77030

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • GenesisCare USA

    Jacksonville, Florida, 32204

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Saddleback Memorial Medical Center

    Laguna Hills, California, 92653

  • OptumCare Cancer Care

    Las Vegas, Nevada, 89102

  • Central Maine Medical Center

    Lewiston, Maine

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • University Medical Center, Inc; DBA University of Louisville

    Louisville, Kentucky, 40202

  • UW Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Texas Oncology-McKinney

    McKinney, Texas, 75071

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549-3417

  • LSU Health Sciences Center -New Orleans

    New Orleans, Louisiana, 70112

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112

  • CHI Health Research Center

    Omaha, Nebraska, 68124

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • University of Nebraska Medical Center

    Omaha, Nebraska

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • Adult Oncology Research

    Orlando, Florida, 32806

  • Texas Oncology - Paris

    Paris, Texas, 75460

  • Illinois CancerCare, P.C.

    Peoria, Illinois, 61615

  • Cancer Center at St. Joseph Hospital and Medical Center

    Phoenix, Arizona, 85004

  • Texas Oncology- Plano West

    Plano, Texas, 75093

  • BRCR Medical Center INC

    Plantation, Florida

  • Redlands Community Hospital (Emad Ibrahim, MD, Inc.)

    Redlands, California, 92373

  • Renown Regional Medical Center Institute for Cancer

    Reno, Nevada, 89502

  • Dignity Health - Mercy Cancer Centers

    Sacramento, California, 95186

  • Sutter Institute for Medical Research

    Sacramento, California, 95816

  • HealthPartners Institute, Regions Cancer Care Center

    Saint Paul, Minnesota, 55101

  • W.G. Bill Hefner VA Med Center

    Salisbury, North Carolina, 28144

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • CHRISTUS Health

    Shreveport, Louisiana, 71105

  • Southern Illinois University, School of Medicine, Simmons Cancer Institute at SIU

    Springfield, Illinois, 62702

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623

  • Baylor Scott & White Health/McClinton Cancer Center

    Waco, Texas, 76712

  • Texas Oncology-Waco

    Waco, Texas, 76712

  • Washington Cancer Institute at MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Innovative Clinical Research Institute

    Whittier, California, 90603

  • Piedmont Radiation Oncology, PA

    Winston-Salem, North Carolina, 27103

  • Saint Joseph Mercy Health System

    Ypsilanti, Michigan, 48197

Other trials in United States

China8 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

  • Affiliated Cancer Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 31000

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 311000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 45003

  • PKUCare Luzhong Hospital

    Zibo, Shandong, 250014

Other trials in China

Spain8 sites

  • Hospital Quirón Teknon, Instituto Oncológico Dr. Rosell

    Barcelona

  • Hospital Universitario Arnau de Vilanova

    Lleida, Catalonia

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Gregorio Marañón

    Madrid

  • Hospital Universitario Puerta de Hierro

    Madrid

  • Hospital Regional Universitario Carlos Haya Medical Oncology Department

    Málaga

  • Hospital Virgen de la Salud

    Toledo, Toledo, 45071

  • Hospital Universitari i Politécnic La Fe

    Valencia

Other trials in Spain

France6 sites

  • Centre Hospitalier de Beauvais

    Beauvais, 60021

  • INSTITUT BERGONIE Centre Régional de Lutte Contre le Cancer

    Bordeaux

  • Groupe Hospitalier Bretagne Sud

    Lorient, 56100

  • CHU Caremeau Service de Pneumologie

    Nîmes, 30029

  • AH-HP Hôpital Saint Louis

    Paris

  • Centre Hospitalier de Saint-Quentin Service de pneumologie

    Saint-Quentin, 21000

Other trials in France

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk

  • Centrum Terapii Współczesnej

    Lodz

  • MS Clinsearch Specjalistyczny NZOZ

    Lublin

  • Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu

    Poznan

  • Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie

    Szczecin, 70-891

Other trials in Poland

Italy4 sites

  • ASL 3, Ospedale Villa Scassi

    Genova, 16132

  • IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    Meldola

  • UOC Oncologia Medica Presidio Ospedaliero di Ravenna AUSL della Romagna

    Ravenna

  • Saronno Hospital

    Saronno, 21047

Other trials in Italy

Belgium3 sites

  • Institut Jules Bordet - Department of Intensive Care and Thoracic Oncology

    Brussels, 1000

  • Clinique André Renard Herstal Oncologie

    Herstal, 4040

  • AZ Sint Maarten

    Mechelen, 2800

Other trials in Belgium

Canada3 sites

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Allan Blair Cancer Center

    Regina, Saskatchewan, S4T 7T1

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Czechia3 sites

  • General University Hospital in Prague

    Prague

  • Thomayerova Nemocnice Dept. of Pneumology

    Prague

  • Vitkovicka nemocnice

    Vítkovice

Other trials in Czechia

Netherlands2 sites

  • St Jansdal Ziekenhuis

    Harderwijk

  • Erasmus Mc

    Rotterdam, 3015

Other trials in Netherlands

Serbia2 sites

  • Bezanijska kosa Clinical Hospital Center

    Belgrade, 11080

  • University Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Austria1 site

  • Medical University Salzburg, State Hospital, University hospital for internal medicine III / PMU

    Salzburg, 5020

Other trials in Austria

Bulgaria1 site

  • Complex Oncology Center (COC) - Plovdiv EOOD,

    Plovdiv, 4004

Other trials in Bulgaria

Croatia1 site

  • University Hospital Centre Zagreb

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Germany1 site

  • Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Innere Medizin IV

    Halle

Other trials in Germany

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Hungary1 site

  • Tolna County, Balassa Janos Hospital, Department of oncology

    Szekszárd, 7100

Other trials in Hungary

Switzerland1 site

  • Kantonsspital Winterthur Tumorzentrum Winterthur

    Winterthur, 8400

Other trials in Switzerland

About this study

Official title: LUNAR: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure

The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-200T device, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment. 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 and PD-1 inhibitors. TTFields have been demonstrated to act synergistically with taxanes and have been shown to be additive when combined with PD-1 inhibitors. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.

In a pilot study, 42 patients with advanced NSCLC who had 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). The combination was well tolerated and the only device-related adverse event was mild to moderate contact dermatitis. 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).

DESCRIPTION OF THE TRIAL:

All patients included in this trial are patients with squamous or non-squamous, stage 4 NSCLC who had disease progression on or after receiving platinum based chemotherapy. In addition, all patients must meet all eligibility criteria.

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

Patients receive docetaxel or immune checkpoint inhibitor in combination with TTFields using the NovoTTF-100L System.

Patients receive docetaxel or immune checkpoint inhibitor without TTFields. 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-100L group, the patients will be treated continuously with the device until disease progression in the thorax and/or liver according to RECIST or irRECIST (Immune-Related Response Evaluation Criteria In Solid Tumors) (depending if the patient is receiving docetaxel or immune checkpoint inhibitor, respectively).

On both arms, patients who have disease progression according to RECIST or irRECIST (depending if the patient is receiving docetaxel or immune checkpoint inhibitor, respectively) will switch to a third line treatment according to local practice.

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 NSCLC with very few side effects.

Being tested
NovoTTF-200T, Immune checkpoint inhibitors or docetaxel
Keywords
Non-Small Cell Lung Cancer, NSCLC, Treatment, Minimal Toxicity, TTFields, TTF, Tumor Treating Fields, Novocure, Docetaxel, PD-1 inhibitor, PD-L1 inhibitor, Immune checkpoint inhibitor
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • NovoTTF-200TDevice

    Also called TTFields

    Patients receive continuous TTFields treatment using the NovoTTF-200T device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the chest. The treatment enables the patient to maintain regular daily routine.

    Other Name: TTFields

    Drug: Immune checkpoint inhibitors or docetaxel Patients receive standard of care with Immune checkpoint inhibitors or docetaxel

  • Immune checkpoint inhibitors or docetaxelDrug

    Patients receive standard of care with Immune checkpoint inhibitors or docetaxel

Study groups in NCT02973789
Study groupRoleWhat they receive
NovoTTF-200TExperimentalPatients receive TTFields using the NovoTTF-200T device together with immune checkpoint inhibitors or docetaxel
Receives: Device: NovoTTF-200T; Drug: Immune checkpoint inhibitors or docetaxel
Best Standard of CareActive comparatorPatients receive best standard of care with immune checkpoint inhibitors or docetaxel
Receives: Drug: Immune checkpoint inhibitors or docetaxel

What is being measured

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

  1. Overall Survival of Patients Treated With TTFields + Docetaxel or Immune Checkpoint Inhibitors vs. Docetaxel or Immune Checkpoint Inhibitors Alone (Superiority Analysis)

    Measured: From date of randomization until the date of death from any cause, assessed up to 12 month after the last participant was enrolled (median duration of follow-up was 10.0 months).

Secondary outcomes (10)

  1. Overall Survival of Patients Treated With TTFields + Immune Checkpoint Inhibitors vs. Immune Checkpoint Inhibitors Alone (Superiority)

    Measured: From date of randomization until the date of death from any cause, assessed up to 12 month after the last participant was enrolled (median duration of follow-up was 10.6 months).

  2. Overall Survival of Patients Treated With TTFields + Docetaxel vs. Docetaxel Alone (Superiority Analysis)

    Measured: From date of randomization until the date of death from any cause, assessed up to 12 month after the last participant was enrolled (median duration of follow-up was 9.7 months).

  3. Overall Survival of Patients Treated With TTFields + Docetaxel Vs. Immune Checkpoint Inhibitors Alone (Non-inferiority Analysis)

    Measured: From date of randomization until the date of death from any cause, assessed up to 12 month after the last participant was enrolled. (median duration of follow-up was 10.1 months)

  4. Progression-free Survival of Patients Treated With Docetaxel or Immune Checkpoint Inhibitors + TTFields vs. Docetaxel or Immune Checkpoint Inhibitors Alone, Based on RECIST Criteria

    Measured: From date of randomization until the date of disease progression according to RECIST criteria, assessed up to 12 month after the last participant was enrolled (median duration of follow-up was 10.0 months, maximal follow-up duration was 64.4 months).

  5. Overall Radiological Response Rate (Based on RECIST Criteria) of Patients Treated With Docetaxel or Immune Checkpoint Inhibitors + TTFields vs. Docetaxel or Immune Checkpoint Inhibitors Alone.

    Measured: From date of randomization until the date of disease progression according to RECIST criteria, assessed up to 12 month after the last participant was enrolled (median duration of follow-up was 4.2 months, maximal follow-up duration was 64.4 months).

  6. Quality of Life Using the EORTC QLQ C30 Questionnaire With LC13 Addendum

    Quality of life was assessed using the EORTC QLQ-C30 and EORTC QLQ-LC13. QLQ-C30 includes global health status; five functioning scales (physical, role, emotional, cognitive, social); three symptom scales (fatigue, pain, nausea/vomiting); and single-item symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). QLQ-LC13 includes 13 lung cancer-specific symptom/treatment items. All scores are transformed to 0-100 per EORTC scoring. For global health and all functioning scales, higher scores indicate better quality of life (0 worst, 100 best). For all symptom scales/items in QLQ-C30 and all QLQ-LC13 measures, higher scores indicate greater symptom burden (0 best, 100 worst). Change from baseline = Week 54 minus baseline; positive change indicates improvement for global health/functioning and worsening for symptoms. A >10-point change was considered clinically meaningful.

    Measured: From baseline up to 54 weeks

  7. Analyses of the Effects of NovoTTF-200T With Each Type of Immune Checkpoint Inhibitor on Overall Survival and Progression Free Survival

    Measured: From date of randomization until the date of death from any cause (OS), or until date of disease progression according to RECIST criteria (PFS) , assessed up to 12 month after last participant enrolled (median duration of follow-up 10.7 months).

  8. Analysis of the Effects of NovoTTF-200T on Overall Survival and Progression Free Survival Within Each Histological Subgroup (Squamous and Non-squamous)

    Measured: From date of randomization until the date of death from any cause (OS), or until date of disease progression according to RECIST criteria (PFS) , assessed up to 12 month after last participant enrolled (median duration of follow-up 10.0 months).

  9. The Effect of Treatment Compliance With NovoTTF-200T on Overall Survival and Progression Free Survival Outcomes

    Measured: From date of randomization until the date of death from any cause (OS), or until date of disease progression according to RECIST criteria (PFS) , assessed up to 12 month after last participant enrolled (median duration of follow-up 10.7 months).

  10. Adverse Events, Severity and Frequency Based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03

    Measured: From date of randomization until the date of death from any cause, or study completion (up to 100 days following treatment termination, maximal follow-up duration was 55.8 months).

Timeline

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

  1. First posted25 Nov 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion24 Sep 2024
  4. Study completion9 Oct 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
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02973789
Sponsor's protocol ID
EF-24
Status last verified
Feb 2026
First submitted
22 Nov 2016
Last updated
18 Mar 2026
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, 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, 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

  • 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-200T and Immune checkpoint inhibitors or docetaxel in people with Nonsmall Cell Lung Cancer and NSCLC, run by NovoCure GmbH at 124 sites in 18 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 11 inclusion and 22 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in United States, China, Spain, France, Poland and 13 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?

Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival of Patients Treated With TTFields + Docetaxel or Immune Checkpoint Inhibitors vs. Docetaxel or Immune Checkpoint Inhibitors Alone (Superiority Analysis) (time frame: From date of randomization until the date of death from any cause, assessed up to 12 month after the last participant was enrolled (median duration of follow-up was 10.0 months).). 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 NCT02973789, which also lists 10 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 18 Mar 2026.

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