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)
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
1 other identifier
interventional
291
18 countries
124
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started Dec 2016
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
124 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2016
CompletedFirst Posted
Study publicly available on registry
November 25, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2024
CompletedResults Posted
Study results publicly available
March 18, 2026
CompletedMarch 18, 2026
February 1, 2026
7.8 years
November 22, 2016
October 8, 2025
February 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival of Patients Treated With TTFields + Docetaxel or Immune Checkpoint Inhibitors vs. Docetaxel or Immune Checkpoint Inhibitors Alone (Superiority Analysis)
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)
Overall Survival of Patients Treated With TTFields + Immune Checkpoint Inhibitors vs. Immune Checkpoint Inhibitors Alone (Superiority)
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).
Overall Survival of Patients Treated With TTFields + Docetaxel vs. Docetaxel Alone (Superiority Analysis)
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).
Overall Survival of Patients Treated With TTFields + Docetaxel Vs. Immune Checkpoint Inhibitors Alone (Non-inferiority Analysis)
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)
Progression-free Survival of Patients Treated With Docetaxel or Immune Checkpoint Inhibitors + TTFields vs. Docetaxel or Immune Checkpoint Inhibitors Alone, Based on RECIST Criteria
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).
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.
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).
- +5 more secondary outcomes
Study Arms (2)
NovoTTF-200T
EXPERIMENTALPatients receive TTFields using the NovoTTF-200T device together with immune checkpoint inhibitors or docetaxel
Best Standard of Care
ACTIVE COMPARATORPatients receive best standard of care with immune checkpoint inhibitors or docetaxel
Interventions
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
Patients receive standard of care with Immune checkpoint inhibitors or docetaxel
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NovoCure GmbHlead
Study Sites (124)
Central Alabama Research
Birmingham, Alabama, 35209, United States
Ironwood Cancer & Research Center
Chandler, Arizona, 85224, United States
Cancer Center at St. Joseph Hospital and Medical Center
Phoenix, Arizona, 85004, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
California Cancer Associates for Research and Excellence, Inc. cCARE
Fresno, California, 93720, United States
St. Joseph Heritage Healthcare
Fullerton, California, 92835, United States
Saddleback Memorial Medical Center
Laguna Hills, California, 92653, United States
Redlands Community Hospital (Emad Ibrahim, MD, Inc.)
Redlands, California, 92373, United States
Dignity Health - Mercy Cancer Centers
Sacramento, California, 95186, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley, Colorado, 80631, United States
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, 06824, United States
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
GenesisCare USA
Jacksonville, Florida, 32204, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
AdventHealth Orlando
Orlando, Florida, 32804, United States
Adult Oncology Research
Orlando, Florida, 32806, United States
BRCR Medical Center INC
Plantation, Florida, United States
University of Illinois Cancer Center
Chicago, Illinois, 60612, United States
Illinois CancerCare, P.C.
Peoria, Illinois, 61615, United States
Southern Illinois University, School of Medicine, Simmons Cancer Institute at SIU
Springfield, Illinois, 62702, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
University Medical Center, Inc; DBA University of Louisville
Louisville, Kentucky, 40202, United States
LSU Health Sciences Center -New Orleans
New Orleans, Louisiana, 70112, United States
Tulane Cancer Center
New Orleans, Louisiana, 70112, United States
CHRISTUS Health
Shreveport, Louisiana, 71105, United States
Central Maine Medical Center
Lewiston, Maine, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Tufts Medical Center, Division of Hematology and Oncology
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Clinical Oncology Associates
Farmington Hills, Michigan, 48336, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, 48336, United States
Saint Joseph Mercy Health System
Ypsilanti, Michigan, 48197, United States
HealthPartners Institute, Regions Cancer Care Center
Saint Paul, Minnesota, 55101, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
CHI Health Research Center
Omaha, Nebraska, 68124, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
OptumCare Cancer Care
Las Vegas, Nevada, 89102, United States
Renown Regional Medical Center Institute for Cancer
Reno, Nevada, 89502, United States
Presbyterian Cancer Center
Albuquerque, New Mexico, 87110, United States
New York-Presbyterian/Queens Radiation Oncology
Flushing, New York, 11355, United States
Northern Westchester Hospital
Mount Kisco, New York, 10549-3417, United States
Stony Brook Cancer Center
Stony Brook, New York, 11794, United States
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28204, United States
W.G. Bill Hefner VA Med Center
Salisbury, North Carolina, 28144, United States
Piedmont Radiation Oncology, PA
Winston-Salem, North Carolina, 27103, United States
Summa Health
Akron, Ohio, 44304, United States
Toledo Clinic Cancer Center
Toledo, Ohio, 43623, United States
Vita Medical Associates, P.C.
Bethlehem, Pennsylvania, 18015, United States
Geisinger Cancer Institute
Danville, Pennsylvania, 17822, United States
UT/Erlanger Oncology & Hematology
Chattanooga, Tennessee, 37403, United States
Texas Oncology - Amarillo
Amarillo, Texas, 79106, United States
Texas Oncology - Arlington
Arlington, Texas, 76012, United States
Christus Health Spohn Ministry
Corpus Christi, Texas, 78404, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Oncology Consultants, P.A.
Houston, Texas, 77030, United States
Texas Oncology-McKinney
McKinney, Texas, 75071, United States
Texas Oncology - Paris
Paris, Texas, 75460, United States
Texas Oncology- Plano West
Plano, Texas, 75093, United States
Baylor Scott & White Health/McClinton Cancer Center
Waco, Texas, 76712, United States
Texas Oncology-Waco
Waco, Texas, 76712, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Overlake Medical Center & Clinics
Bellevue, Washington, 98004, United States
UW Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Medical University Salzburg, State Hospital, University hospital for internal medicine III / PMU
Salzburg, 5020, Austria
Institut Jules Bordet - Department of Intensive Care and Thoracic Oncology
Brussels, 1000, Belgium
Clinique André Renard Herstal Oncologie
Herstal, 4040, Belgium
AZ Sint Maarten
Mechelen, 2800, Belgium
Complex Oncology Center (COC) - Plovdiv EOOD,
Plovdiv, 4004, Bulgaria
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
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, Canada
Allan Blair Cancer Center
Regina, Saskatchewan, S4T 7T1, Canada
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 45003, China
PKUCare Luzhong Hospital
Zibo, Shandong, 250014, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 31000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 311000, China
Sun Yat-sen University Cancer Center
Guangzhou, China
University Hospital Centre Zagreb
Zagreb, City of Zagreb, 10000, Croatia
General University Hospital in Prague
Prague, Czechia
Thomayerova Nemocnice Dept. of Pneumology
Prague, Czechia
Vitkovicka nemocnice
Vítkovice, Czechia
Centre Hospitalier de Beauvais
Beauvais, 60021, France
INSTITUT BERGONIE Centre Régional de Lutte Contre le Cancer
Bordeaux, France
Groupe Hospitalier Bretagne Sud
Lorient, 56100, France
CHU Caremeau Service de Pneumologie
Nîmes, 30029, France
AH-HP Hôpital Saint Louis
Paris, France
Centre Hospitalier de Saint-Quentin Service de pneumologie
Saint-Quentin, 21000, France
Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Innere Medizin IV
Halle, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
Tolna County, Balassa Janos Hospital, Department of oncology
Szekszárd, 7100, Hungary
ASL 3, Ospedale Villa Scassi
Genova, 16132, Italy
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, Italy
UOC Oncologia Medica Presidio Ospedaliero di Ravenna AUSL della Romagna
Ravenna, Italy
Saronno Hospital
Saronno, 21047, Italy
St Jansdal Ziekenhuis
Harderwijk, Netherlands
Erasmus Mc
Rotterdam, 3015, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Centrum Terapii Współczesnej
Lodz, Poland
MS Clinsearch Specjalistyczny NZOZ
Lublin, Poland
Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu
Poznan, Poland
Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie
Szczecin, 70-891, Poland
Bezanijska kosa Clinical Hospital Center
Belgrade, 11080, Serbia
University Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Hospital Universitario Arnau de Vilanova
Lleida, Catalonia, Spain
Hospital Virgen de la Salud
Toledo, Toledo, 45071, Spain
Hospital Quirón Teknon, Instituto Oncológico Dr. Rosell
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Regional Universitario Carlos Haya Medical Oncology Department
Málaga, Spain
Hospital Universitari i Politécnic La Fe
Valencia, Spain
Kantonsspital Winterthur Tumorzentrum Winterthur
Winterthur, 8400, Switzerland
Related Publications (10)
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.
PMID: 15126372BACKGROUNDKirson 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.
PMID: 17551011BACKGROUNDStupp 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.
PMID: 22608262BACKGROUNDPless 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.
PMID: 23891283BACKGROUNDKirson 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.
PMID: 19387848BACKGROUNDGiladi 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.
PMID: 26658786BACKGROUNDGiladi 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.
PMID: 25213867BACKGROUNDStupp 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.
PMID: 26670971BACKGROUNDVoloshin T, Kaynan N, Davidi S, Porat Y, Shteingauz A, Schneiderman RS, Zeevi E, Munster M, Blat R, Tempel Brami C, Cahal S, Itzhaki A, Giladi M, Kirson ED, Weinberg U, Kinzel A, Palti Y. Tumor-treating fields (TTFields) induce immunogenic cell death resulting in enhanced antitumor efficacy when combined with anti-PD-1 therapy. Cancer Immunol Immunother. 2020 Jul;69(7):1191-1204. doi: 10.1007/s00262-020-02534-7. Epub 2020 Mar 6.
PMID: 32144446BACKGROUNDLeal T, Kotecha R, Ramlau R, Zhang L, Milanowski J, Cobo M, Roubec J, Petruzelka L, Havel L, Kalmadi S, Ward J, Andric Z, Berghmans T, Gerber DE, Kloecker G, Panikkar R, Aerts J, Delmonte A, Pless M, Greil R, Rolfo C, Akerley W, Eaton M, Iqbal M, Langer C; LUNAR Study Investigators. Tumor Treating Fields therapy with standard systemic therapy versus standard systemic therapy alone in metastatic non-small-cell lung cancer following progression on or after platinum-based therapy (LUNAR): a randomised, open-label, pivotal phase 3 study. Lancet Oncol. 2023 Sep;24(9):1002-1017. doi: 10.1016/S1470-2045(23)00344-3.
PMID: 37657460DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Medical Director
- Organization
- Novocure
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2016
First Posted
November 25, 2016
Study Start
December 1, 2016
Primary Completion
September 24, 2024
Study Completion
October 9, 2024
Last Updated
March 18, 2026
Results First Posted
March 18, 2026
Record last verified: 2026-02