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JOURNAL ONKOLOGIE – STUDIE

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)

Rekrutierend

NCT-Nummer:
NCT02973789

Studienbeginn:
Dezember 2016

Letztes Update:
21.02.2021

Wirkstoff:
Immune checkpoint inhibitors or docetaxel

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
NovoCure Ltd.

Collaborator:
-

Kontakt

Studienlocations (3 von 102)

Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV Onkologie/Hämatologie
Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Antje Kleinbauer
Phone: +49 345/557-1386
E-Mail: innere4.studienzentrale@uk-halle.de
» Ansprechpartner anzeigen
Cancer Center at St. Joseph Hospital and Medical Center
85004 Phoenix
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Norissa Honea, RN, PHD
Phone: 602-406-6267
E-Mail: Norissa.Honea@DignityHealth.org
» Ansprechpartner anzeigen
California Cancer Associates for Research and Excellence, Inc. cCARE
93720 Fresno
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Micheal Mott
Phone: 559-326-1222
E-Mail: MMott@ccare.com
» Ansprechpartner anzeigen
Banner MD Anderson Cancer Center at North Colorado Medical Center
80631 Greeley
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Mandy Garza
Phone: 970-810-3894
E-Mail: Lin.Hao@bannerhealth.com
» Ansprechpartner anzeigen
Washington Cancer Institute at MedStar Washington Hospital Center
20010 Washington
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Edwards Okobi
Phone: 202-877-3061
E-Mail: Okelue.e.okobi@medstar.net
» Ansprechpartner anzeigen
Franciscan Health Indianapolis
46237 Indianapolis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Cindy Stoner, BS, CCRP
Phone: 317-528-7060
E-Mail: Cynthia.Stoner@franciscanalliance.org
» Ansprechpartner anzeigen
University of Maryland School of Medicine
21201 Baltimore
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Joann Alimurong
Phone: 410-328-2703
E-Mail: Joann.Alimurong@UMM.EDU


Phone: 443-224-8063
» Ansprechpartner anzeigen
Tufts Medical Center, Division of Hematology and Oncology
02111 Boston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Laura Scanlon, RN, BSN
Phone: 617-636-9161
E-Mail: lscanlon@tuftsmedicalcenter.org
» Ansprechpartner anzeigen
Washington University School of Medicine
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Oncology Hematology West, PC dba Nebraska Cancer Specialists
68130 Omaha
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Ralph Hauke, MD

Megan Meays, M.A.M., CCRA
Phone: +1 402-691-6971
E-Mail: mmeays@nebraskacancer.com
» Ansprechpartner anzeigen
Renown Regional Medical Center Institute for Cancer
89502 Reno
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Kimberly Olsen-Wilson
Phone: 775-982-5050
E-Mail: KOlsen-Wilson@renown.org
» Ansprechpartner anzeigen
New York-Presbyterian/Queens Radiation Oncology
11355 Flushing
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Steven J. DiBiase, MD
Phone: 718-670-1501
E-Mail: sed9088@med.cornell.edu

718-670-1633
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W.G. Bill Hefner VA Med Center
28144 Salisbury
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Stephanie Burrison, MSN-RN
Phone: 704-638-9000
Phone (ext.): 14693
E-Mail: Stephanie.burrison@va.gov
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Texas Oncology- Baylor Charles A. Sammons Cancer Center
75246 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Ericka Valdez
Phone: 214-370-1126
E-Mail: Ericka.Valdez@usoncology.com
» Ansprechpartner anzeigen
The University of Texas Southwestern Medical Center
75390 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Jessica Saltarski
Phone: 214-648-7023
E-Mail: Jessica.Saltarski@UTSouthwestern.edu
» Ansprechpartner anzeigen
Oncology Consultants, P.A.
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Laura T. Guerra, RN, CCRC
Phone: 713-600-0913
E-Mail: lguerra@oncologyconsultants.com


Phone: 713-516-4968
» Ansprechpartner anzeigen
Baylor Scott & White Health/McClinton Cancer Center
76712 Waco
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Michele Richardson, BA CCRC
Phone: 254-202-2645
E-Mail: michele.richardson@BSWHealth.org
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Huntsman Cancer Institute/University of Utah
84112 Salt Lake City
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Elizabeth Constantz
Phone: 801-587-4567
E-Mail: Elizabeth.Constantz@hci.utah.edu
» Ansprechpartner anzeigen
Uniklinikum Salzburg Landeskrankenhaus - Universitätsklinik für Innere Medizin III der PMU
5020 Salzburg
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Michaela Schachner, SC Mag.
Phone: +43 57255 - 25823
E-Mail: m.schachner@salk.at
» Ansprechpartner anzeigen
Institut Jules Bordet - Department of Intensive Care and Thoracic Oncology
1000 Brussels
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Thierry Berghmans, MD
Phone: +32 25 41 31 91
E-Mail: study.implementation@bordet.be
» Ansprechpartner anzeigen
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
J1H 5N4 Sherbrooke
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Anick Champoux, RN
Phone: 819-346-1110 ext 12811
E-Mail: anick.champoux.ciussse-chus@ssss.gouv.qc.ca
» Ansprechpartner anzeigen
Thomayerova Nemocnice Dept. of Pneumology
Prague
CzechiaRekrutierend» Google-Maps
Ansprechpartner:
Libor Havel, MD
Phone: +420607822622
E-Mail: libor.havel@ftn.cz

Eva Becisová
E-Mail: eva.becisova@ftn.cz
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Vitkovicka nemocnice
Vitkovice
CzechiaRekrutierend» Google-Maps
Ansprechpartner:
Jaromir Roubec
E-Mail: jaromir.roubec@vtn.agel.cz

Zuzana Gerlochová
Phone: +42 0595633175
E-Mail: zuzana.gerlochova@ymail.com
» Ansprechpartner anzeigen
INSTITUT BERGONIE Centre Régional de Lutte Contre le Cancer
Bordeaux
FranceRekrutierend» Google-Maps
Ansprechpartner:
Sylvestre Le Moulec, MD
Phone: +33 556 333 222
E-Mail: s.le-moulec@bordeaux.unicancer.fr

Elodie Ducasse
Phone: +33 556 33 33 71
E-Mail: e.ducasse@bordeaux.unicancer.fr
» Ansprechpartner anzeigen
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Angelo Delmonte, MD
Phone: +39 0543 739100
E-Mail: angelo.delmonte@irst.emr.it
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ASST della Valle Olona - Presidio Ospedaliero di Saronno
21047 Saronno
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Claudio Verusio, MD
Phone: +39 029613576
E-Mail: claudio.verusio@asst-valleolona.it
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MS Clinsearch Specjalistyczny NZOZ
Lublin
PolandRekrutierend» Google-Maps
Ansprechpartner:
Janusz Milanowski, Prof.
Phone: +48817244431
E-Mail: jmilanowski@op.pl

Iwona Kawiak
Phone: +48817244431
E-Mail: iwonka600@wp.pl
» Ansprechpartner anzeigen
Katedra i Klinika Onkologii; Szpital Kliniczny Przemienienia Pańskiego UM w Poznaniu
Poznan
PolandRekrutierend» Google-Maps
Ansprechpartner:
Klaudia Wesołowska
Phone: +48 618549038
E-Mail: claudiawesolowska@gmail.com
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Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie, Oddział Onkologii Klinicznej i Chemioterapii
70-891 Szczecin
PolandRekrutierend» Google-Maps
Ansprechpartner:
Piotr Serwatowski, MD PhD
Phone: +48 91 44 27 209
E-Mail: piotrserwatowski@wp.pl
» Ansprechpartner anzeigen
Centrum Terapii Współczesnej
Łódź
PolandRekrutierend» Google-Maps
Ansprechpartner:
Małgorzata Ulanska, Dr.
E-Mail: m.ulanska@ctw.com.pl

Iwona Majchrowska
Phone: +48 422 300 607
E-Mail: i.majchrowska@ctw.com.pl
» Ansprechpartner anzeigen
Hospital Universitario Arnau de Vilanova
Lleida
SpainRekrutierend» Google-Maps
Ansprechpartner:
Juan Felipe Córdoba, MD
E-Mail: jufeco120@gmail.com

Joel Salla
Phone: +34 97 370 53 51
E-Mail: eoncolleida@gmail.com
» Ansprechpartner anzeigen
HGU Gregorio Marañón
Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Rosa Álvarez Álvarez, MD
Phone: +34 915868117/8115
E-Mail: rosa.alvarez.al@gmail.com

Sandra Florez
E-Mail: Sandraflorez.hgugm@hotmail.com
» Ansprechpartner anzeigen
Hospital Universitario 12 de Octubre
Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Santiago Ponce, MD
E-Mail: sponceaix@gmail.com

Sara Gómez
Phone: +34 91 469 23 13
E-Mail: abecia@h12o.es
» Ansprechpartner anzeigen
Hospital Universitario Puerta de Hierro
Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Mariano Provencio, MD, PhD
Phone: +34 91 191 416280
E-Mail: mprovencio.ensayosclinicos@gmail.com

Sandra Cerdeira
E-Mail: scerdeira.hpth@salud.madrid.org
» Ansprechpartner anzeigen
Hospital Universitario Málaga Regional. IBIMA
Málaga
SpainRekrutierend» Google-Maps
Ansprechpartner:
Manuel Cobo, MD
Phone: +34 95 129 14 25
E-Mail: manuelcobodols@yahoo.es

Alicia Medina
Phone: +34 95 129 14 25
E-Mail: alicia.medina@ibima.eu
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. 22 years of age and older

2. Life expectancy of ≥ 3 months

3. Histological diagnosis of squamous or non-squamous, inoperable, stage 4 NSCLC

4. Diagnosis of radiological progression while on or after first platinum-based systemic

therapy

5. Randomization within 28 days of diagnosis of last progression

6. ECOG Score of 0-2

7. Assigned by the physician to receive either docetaxel or immune checkpoint inhibitor

per standard of care regimens

8. Able to operate the NovoTTF-100L device independently or with the help of a caregiver

9. Signed informed consent for the study protocol

Exclusion Criteria:

1. Presence of brain metastasis or leptomeningeal spread of the disease

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

receive immunotherapy

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

4. Severe comorbidities:

1. 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

2. History of significant cardiovascular disease unless the disease is well

controlled. Significant cardiac disease includes second/third degree heart block;

significant ischemic heart disease; poorly controlled hypertension; congestive

heart failure of the New York Heart Association (NYHA) Class II or worse (slight

limitation of physical activity; comfortable at rest, but ordinary activity

results in fatigue, palpitation or dyspnea)

3. History of arrhythmia that is symptomatic or requires treatment. Patients with

atrial fibrillation or flutter controlled by medication are not excluded from

participation in the trial

4. History of pericarditis

5. History of interstitial lung disease

6. History of cerebrovascular accident (CVA) within 6 months prior to randomization

or that is not stable

7. Active infection or serious underlying medical condition that would impair the

ability of the patient to received protocol therapy

8. 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

9. 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

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

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

torso

7. Known allergies to medical adhesives or hydrogel

8. Pregnancy or breast-feeding (patients with reproductive potential must use effective

contraception methods throughout the entire study period, as determined by their

investigator/gynecologist)

9. Admitted to an institution by administrative or court order

Studien-Rationale

Primary outcome:

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



Secondary outcome:

1. Overall survival of patients treated with TTFields + docetaxel vs. docetaxel alone (superiority analysis) (Time Frame - 4 years)

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

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

6. Quality of life using the EORTC QLQ C30 questionnaire with LC13 addendum (Time Frame - 4 years)

7. Analyses of the effects of NovoTTF-100L with each type of immune checkpoint inhibitor on overall survival and progression free survival (Time Frame - 4 years)

8. Analysis of the effects of NovoTTF-100L on overall survival and progression free survival within each histological subgroup (squamous and non-squamous) (Time Frame - 4 years)

9. The effect of treatment compliance with NovoTTF-100L on overall survival and progression free survival outcomes (Time Frame - 4 years)

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

Studien-Arme

  • Experimental: NovoTTF-100L
    Patients receive TTFields using the NovoTTF-100L System together with immune checkpoint inhibitors or docetaxel
  • Active Comparator: Best Standard of Care
    Patients receive best standard of care with immune checkpoint inhibitors or docetaxel

Geprüfte Regime

  • NovoTTF-100L (TTFields):
    Patients receive continuous TTFields treatment using the NovoTTF-100L 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.
  • Immune checkpoint inhibitors or docetaxel:
    Patients receive standard of care with Immune checkpoint inhibitors or docetaxel

Quelle: ClinicalTrials.gov


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