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)

• Sponsor: NovoCure GmbH (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02973789
• Collaborator: (none)
• Enrollment: 276
• Locations: 124
• Arms: 2
• Duration (Months): 81
• Patients Per Site: 2.2
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nonsmall Cell Lung Cancer; NSCLC	Device: NovoTTF-200T; Drug: Immune checkpoint inhibitors or docetaxel	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 276 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NovoTTF-200T Patients receive TTFields using the NovoTTF-200T device together with immune checkpoint inhibitors or docetaxel	Device: NovoTTF-200T; 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; Other Names: TTFields ; Drug: Immune checkpoint inhibitors or docetaxel; Patients receive standard of care with Immune checkpoint inhibitors or docetaxel
Active Comparator: Best Standard of Care Patients receive best standard of care with immune checkpoint inhibitors or docetaxel	Drug: Immune checkpoint inhibitors or docetaxel; Patients receive standard of care with Immune checkpoint inhibitors or docetaxel

Outcome Measures

Primary Outcome Measures

1. Overall survival of patients treated with TTFields + docetaxel or immune checkpoint inhibitors vs. docetaxel or immune checkpoint inhibitors alone (superiority analysis) [4 years]

Secondary Outcome Measures

1. Overall survival of patients treated with TTFields + docetaxel vs. docetaxel alone (superiority analysis) [4 years]

2. Overall survival of patients treated with TTFields + immune checkpoint inhibitors vs. immune checkpoint inhibitors alone (superiority) [4 years]

3. Overall Survival of patients treated with TTFields + docetaxel Vs. immune checkpoint inhibitors alone (non-inferiority analysis) [4 years]

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 [4 years]

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. [4 years]

6. Quality of life using the EORTC QLQ C30 questionnaire with LC13 addendum [4 years]

7. Analyses of the effects of NovoTTF-200T with each type of immune checkpoint inhibitor on overall survival and progression free survival [4 years]

8. Analysis of the effects of NovoTTF-200T on overall survival and progression free survival within each histological subgroup (squamous and non-squamous) [4 years]

9. The effect of treatment compliance with NovoTTF-200T on overall survival and progression free survival outcomes [4 years]

10. Adverse events, severity and frequency based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03 [4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 22 years of age and older (some regional variations to inclusion age exist)

2. Life expectancy of ≥ 3 months

3. Histological diagnosis of squamous or non-squamous, inoperable, metastatic NSCLC

4. Diagnosis of radiological progression while on or after first platinum-based systemic therapy administered for advanced or metastatic disease.

5. 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.

6. 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.

7. 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.

8. ECOG Score of 0-2

9. Assigned by the physician to receive either docetaxel or immune checkpoint inhibitor per standard of care regimen

10. Able to operate the NovoTTF-200T device independently or with the help of a caregiver

11. Signed informed consent for the study protocol

Exclusion Criteria:

1. 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:

2. The patients are neurologically returned to baseline (except for residual signs or symptoms related to CNS treatment).

3. No treatment for the metastases to CNS during the screening period (e.g. surgery, radiotherapy, corticosteroid therapy- prednisone > 10 mg/day or equivalent).

4. No progress in CNS lesions as indicated by MRI within 14 days prior to randomization.

5. No meningeal metastasis or spinal cord compression.

6. Patients planned to receive immune checkpoint inhibitor with contra-indications to receive immunotherapy

7. Patients planned to receive docetaxel with contra-indications to receive docetaxel

8. Severe comorbidities:

9. 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

10. 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)

11. 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

12. History of pericarditis

13. History of interstitial lung disease

14. History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable

15. Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy

16. 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

17. 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

18. Concurrent treatment with other experimental treatments for NSCLC while on the study

19. Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso

20. Known allergies to medical adhesives or hydrogel

21. Pregnancy or breast-feeding (patients with reproductive potential must use effective contraception methods throughout the entire study period, as determined by their investigator/gynecologist)

22. Admitted to an institution by administrative or court order

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Alabama Research	Birmingham	Alabama	United States	35209
2	Ironwood Cancer & Research Center	Chandler	Arizona	United States	85224
3	Cancer Center at St. Joseph Hospital and Medical Center	Phoenix	Arizona	United States	85004
4	Beverly Hills Cancer Center	Beverly Hills	California	United States	90211
5	California Cancer Associates for Research and Excellence, Inc. cCARE	Fresno	California	United States	93720
6	St. Joseph Heritage Healthcare	Fullerton	California	United States	92835
7	Saddleback Memorial Medical Center	Laguna Hills	California	United States	92653
8	Redlands Community Hospital (Emad Ibrahim, MD, Inc.)	Redlands	California	United States	92373
9	Dignity Health - Mercy Cancer Centers	Sacramento	California	United States	95186
10	Sutter Institute for Medical Research	Sacramento	California	United States	95816
11	Innovative Clinical Research Institute	Whittier	California	United States	90603
12	Banner MD Anderson Cancer Center at North Colorado Medical Center	Greeley	Colorado	United States	80631
13	Associated Neurologists of Southern CT, P.C.	Fairfield	Connecticut	United States	06824
14	Washington Cancer Institute at MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
15	GenesisCare USA	Jacksonville	Florida	United States	32204
16	Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
17	Miami Cancer Institute	Miami	Florida	United States	33176
18	AdventHealth Orlando	Orlando	Florida	United States	32804
19	Adult Oncology Research	Orlando	Florida	United States	32806
20	BRCR Medical Center INC	Plantation	Florida	United States
21	University of Illinois Cancer Center	Chicago	Illinois	United States	60612
22	Illinois CancerCare, P.C.	Peoria	Illinois	United States	61615
23	Southern Illinois University, School of Medicine, Simmons Cancer Institute at SIU	Springfield	Illinois	United States	62702
24	Franciscan Health Indianapolis	Indianapolis	Indiana	United States	46237
25	University of Kansas Cancer Center	Westwood	Kansas	United States	66205
26	Norton Cancer Institute	Louisville	Kentucky	United States	40202
27	University Medical Center, Inc; DBA University of Louisville	Louisville	Kentucky	United States	40202
28	LSU Health Sciences Center -New Orleans	New Orleans	Louisiana	United States	70112
29	Tulane Cancer Center	New Orleans	Louisiana	United States	70112
30	CHRISTUS Health	Shreveport	Louisiana	United States	71105
31	Central Maine Medical Center	Lewiston	Maine	United States
32	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201
33	Tufts Medical Center, Division of Hematology and Oncology	Boston	Massachusetts	United States	02111
34	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
35	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
36	Clinical Oncology Associates	Farmington Hills	Michigan	United States	48336
37	Detroit Clinical Research Center	Farmington Hills	Michigan	United States	48336
38	Saint Joseph Mercy Health System	Ypsilanti	Michigan	United States	48197
39	HealthPartners Institute, Regions Cancer Care Center	Saint Paul	Minnesota	United States	55101
40	Saint Luke's Cancer Institute	Kansas City	Missouri	United States	64111
41	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
42	CHI Health Research Center	Omaha	Nebraska	United States	68124
43	Oncology Hematology West, PC dba Nebraska Cancer Specialists	Omaha	Nebraska	United States	68130
44	University of Nebraska Medical Center	Omaha	Nebraska	United States
45	OptumCare Cancer Care	Las Vegas	Nevada	United States	89102
46	Renown Regional Medical Center Institute for Cancer	Reno	Nevada	United States	89502
47	Presbyterian Cancer Center	Albuquerque	New Mexico	United States	87110
48	New York-Presbyterian/Queens Radiation Oncology	Flushing	New York	United States	11355
49	Northern Westchester Hospital	Mount Kisco	New York	United States	10549-3417
50	Stony Brook Cancer Center	Stony Brook	New York	United States	11794
51	Oncology Specialists of Charlotte	Charlotte	North Carolina	United States	28204
52	W.G. Bill Hefner VA Med Center	Salisbury	North Carolina	United States	28144
53	Piedmont Radiation Oncology, PA	Winston-Salem	North Carolina	United States	27103
54	Summa Health	Akron	Ohio	United States	44304
55	Toledo Clinic Cancer Center	Toledo	Ohio	United States	43623
56	Vita Medical Associates, P.C.	Bethlehem	Pennsylvania	United States	18015
57	Geisinger Cancer Institute	Danville	Pennsylvania	United States	17822
58	UT/Erlanger Oncology & Hematology	Chattanooga	Tennessee	United States	37403
59	Texas Oncology - Amarillo	Amarillo	Texas	United States	79106
60	Texas Oncology - Arlington	Arlington	Texas	United States	76012
61	Christus Health Spohn Ministry	Corpus Christi	Texas	United States	78404
62	Dallas VA Medical Center	Dallas	Texas	United States	75216
63	Texas Oncology- Baylor Charles A. Sammons Cancer Center	Dallas	Texas	United States	75246
64	The University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
65	Oncology Consultants, P.A.	Houston	Texas	United States	77030
66	Texas Oncology-McKinney	McKinney	Texas	United States	75071
67	Texas Oncology - Paris	Paris	Texas	United States	75460
68	Texas Oncology- Plano West	Plano	Texas	United States	75093
69	Baylor Scott & White Health/McClinton Cancer Center	Waco	Texas	United States	76712
70	Texas Oncology-Waco	Waco	Texas	United States	76712
71	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah	United States	84112
72	Overlake Medical Center & Clinics	Bellevue	Washington	United States	98004
73	UW Carbone Cancer Center	Madison	Wisconsin	United States	53792
74	Medical University Salzburg, State Hospital, University hospital for internal medicine III / PMU	Salzburg		Austria	5020
75	Institut Jules Bordet - Department of Intensive Care and Thoracic Oncology	Brussels		Belgium	1000
76	Clinique André Renard Herstal Oncologie	Herstal		Belgium	4040
77	AZ Sint Maarten	Mechelen		Belgium	2800
78	Complex Oncology Center (COC) - Plovdiv EOOD,	Plovdiv		Bulgaria	4004
79	McGill University Health Centre	Montréal	Quebec	Canada	H4A 3J1
80	Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)	Sherbrooke	Quebec	Canada	J1H 5N4
81	Allan Blair Cancer Center	Regina	Saskatchewan	Canada	S4T 7T1
82	Beijing Cancer Hospital	Beijing	Beijing	China
83	Affiliated Cancer Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China
84	Henan Cancer Hospital	Zhengzhou	Henan	China	450003
85	Henan Provincial People's Hospital	Zhengzhou	Henan	China	45003
86	PKUCare Luzhong Hospital	Zibo	Shandong	China	250014
87	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	31000
88	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	311000
89	Sun Yat-sen University Cancer Center	Guangzhou		China
90	University Hospital Centre Zagreb	Zagreb		Croatia	10000
91	General University Hospital in Prague	Prague		Czechia
92	Thomayerova Nemocnice Dept. of Pneumology	Prague		Czechia
93	Vitkovicka nemocnice	Vitkovice		Czechia
94	Centre Hospitalier de Beauvais	Beauvais		France	60021
95	INSTITUT BERGONIE Centre Régional de Lutte Contre le Cancer	Bordeaux		France
96	Groupe Hospitalier Bretagne Sud	Lorient		France	56100
97	CHU Caremeau Service de Pneumologie	Nîmes		France	30029
98	AH-HP Hôpital Saint Louis	Paris		France
99	Centre Hospitalier de Saint-Quentin Service de pneumologie	Saint-Quentin		France	21000
100	Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Innere Medizin IV	Halle (Saale)		Germany
101	Queen Mary Hospital	Hong Kong		Hong Kong
102	Tolna County, Balassa Janos Hospital, Department of oncology	Szekszárd		Hungary	7100
103	ASL 3, Ospedale Villa Scassi	Genova		Italy	16132
104	IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)	Meldola		Italy
105	UOC Oncologia Medica Presidio Ospedaliero di Ravenna AUSL della Romagna	Ravenna		Italy
106	Saronno Hospital	Saronno		Italy	21047
107	St Jansdal Ziekenhuis	Harderwijk		Netherlands
108	Erasmus Mc	Rotterdam		Netherlands	3015
109	Uniwersyteckie Centrum Kliniczne	Gdansk		Poland
110	MS Clinsearch Specjalistyczny NZOZ	Lublin		Poland
111	Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu	Poznan		Poland
112	Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie	Szczecin		Poland	70-891
113	Centrum Terapii Współczesnej	Łódź		Poland
114	Bezanijska kosa Clinical Hospital Center	Belgrade		Serbia	11080
115	University Clinical Center Kragujevac	Kragujevac		Serbia	34000
116	Hospital Universitario Arnau de Vilanova	Lleida	Catalonia	Spain
117	Hospital Quirón Teknon, Instituto Oncológico Dr. Rosell	Barcelona		Spain
118	Hospital Universitario 12 de Octubre	Madrid		Spain
119	Hospital Universitario Gregorio Marañón	Madrid		Spain
120	Hospital Universitario Puerta de Hierro	Madrid		Spain
121	Hospital Regional Universitario Carlos Haya Medical Oncology Department	Málaga		Spain
122	Hospital Virgen de la Salud	Toledo		Spain	45071
123	Hospital Universitari i Politécnic La Fe	Valencia		Spain
124	Kantonsspital Winterthur Tumorzentrum Winterthur	Winterthur		Switzerland	8400

Sponsors and Collaborators

• NovoCure GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Kirson ED, Dbalý 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. Epub 2007 Jun 5.
• 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.
• 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.
• 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.
• 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.
• Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbalý 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.
• Voloshin 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.

• Responsible Party: NovoCure GmbH
• ClinicalTrials.gov Identifier: NCT02973789
• Other Study ID Numbers: EF-24
• First Posted: Nov 25, 2016
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by NovoCure GmbH: 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
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Docetaxel; Immune Checkpoint Inhibitors

Study Results

No Results Posted as of Aug 22, 2022