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Trial record 2 of 30 for:    novocure

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)

This study is currently recruiting participants.
Verified December 2017 by NovoCure Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02973789
First Posted: November 25, 2016
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
NovoCure Ltd.
  Purpose
The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L System, 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 Intervention Phase
Nonsmall Cell Lung Cancer Device: NovoTTF-100L Drug: Immune checkpoint inhibitors or docetaxel Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:
  • 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 Measures:
  • Overall survival of patients treated with TTFields + docetaxel vs. docetaxel alone (superiority analysis) [ Time Frame: 4 years ]
  • Overall survival of patients treated with TTFields + immune checkpoint inhibitors vs. immune checkpoint inhibitors alone (superiority) [ Time Frame: 4 years ]
  • Overall Survival of patients treated with TTFields + docetaxel Vs. immune checkpoint inhibitors alone (non-inferiority analysis) [ Time Frame: 4 years ]
  • 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 ]
  • 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 ]
  • Quality of life using the EORTC QLQ C30 questionnaire with LC13 addendum [ Time Frame: 4 years ]
  • 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 ]
  • 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 ]
  • The effect of treatment compliance with NovoTTF-100L on overall survival and progression free survival outcomes [ Time Frame: 4 years ]
  • Adverse events, severity and frequency based on Common Terminology Criteria for Adverse Events (CTCAE) V4.03 [ Time Frame: 4 years ]

Estimated Enrollment: 534
Study Start Date: December 2016
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NovoTTF-100L
Patients receive TTFields using the NovoTTF-100L System together with immune checkpoint inhibitors or docetaxel
Device: NovoTTF-100L
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.
Other Name: 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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973789


Contacts
Contact: Lori A. Ladd patientinfo@novocure.com

Locations
Austria
Ordensklinikum Linz GmbH Recruiting
Linz, Austria
Contact: Michael Schumacher, MD    +43 732 7676 3220    michael.schumacher@ordensklinikum.at   
Contact: Tanja Koppler    +43 732 7676 4414    tanja.koppler@ordensklinikum.at   
Principal Investigator: Michael Schumacher, MD         
Czechia
Thomayerova Nemocnice Dept. of Pneumology Recruiting
Prague, Czechia
Contact: Libor Havel, MD    +420607822622    libor.havel@ftn.cz   
Contact: Eva Becisová       eva.becisova@ftn.cz   
Principal Investigator: Libor Havel, MD         
Všeobecná Fakultní Nemocnice Recruiting
Prague, Czechia
Contact: Zemanová Milada, MD    +420 224 966 763    milada.zemanova@vfn.cz   
Principal Investigator: Lubos Petruzelka, Prof.         
Vitkovicka nemocnice Recruiting
Vitkovice, Czechia
Contact: Jaromir Roubec       jaromir.roubec@vtn.agel.cz   
Contact: Zuzana Gerlochová    +42 0595633175    zuzana.gerlochova@ymail.com   
Principal Investigator: Jaromir Roubec         
France
INSTITUT BERGONIE Centre Régional de Lutte Contre le Cancer Recruiting
Bordeaux, France
Contact: Sylvestre Le Moulec, MD    +33 556 333 222    s.le-moulec@bordeaux.unicancer.fr   
Contact: Elodie Ducasse    +33 556 33 33 71    e.ducasse@bordeaux.unicancer.fr   
Principal Investigator: Sylvestre Le Moulec, MD         
Italy
UOC Oncologia Medica Presidio Ospedaliero di Ravenna Recruiting
Ravenna, Italy
Contact: Michela Spreafico, Dr    +390544286223    michela.spreafico@gmail.com   
Principal Investigator: Federico Cappuzzo, Prof         
Poland
Uniwersyteckie Centrum Kliniczne Recruiting
Gdansk, Poland
Contact: Ewa Szutowicz-Zielinska, MD    +48 583492271      
Principal Investigator: Ewa Szutowicz-Zielinska, MD         
MS Clinsearch Specjalistyczny NZOZ Recruiting
Lublin, Poland
Contact: Janusz Milanowski, Prof.    +48817244431    jmilanowski@op.pl   
Contact: Iwona Kawiak    +48817244431    iwonka600@wp.pl   
Principal Investigator: Janusz Milanowski, Prof.         
Katedra i Klinika Onkologii; Szpital Kliniczny Przemienienia Pańskiego UM w Poznaniu Recruiting
Poznan, Poland
Contact: Klaudia Wesołowska    +48 618549038    claudiawesolowska@gmail.com   
Principal Investigator: Rodryg Ramlau         
Spain
Hospital Universitario Arnau de Vilanova Recruiting
Lleida, Catalonia, Spain
Contact: Juan Felipe Córdoba, MD       jufeco120@gmail.com   
Contact: Joel Salla    +34 97 370 53 51    eoncolleida@gmail.com   
Principal Investigator: Juan Felipe Córdoba, MD         
Hospital Quirón Teknon, Instituto Oncológico Dr. Rosell Recruiting
Barcelona, Spain
Contact    + (34) 93 546 01 43    clinicaltrials@oncorosell.com   
HGU Gregorio Marañón Recruiting
Madrid, Spain
Contact: Rosa Álvarez Álvarez, MD    +34 915868117/8115    rosa.alvarez.al@gmail.com   
Contact: Sandra Florez       Sandraflorez.hgugm@hotmail.com   
Principal Investigator: Rosa Álvarez Álvarez, MD         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain
Contact: Santiago Ponce, MD       sponceaix@gmail.com   
Contact: Sara Gómez    +34 91 469 23 13    abecia@h12o.es   
Principal Investigator: Santiago Ponce, MD         
Hospital Universitario Puerta de Hierro Recruiting
Madrid, Spain
Contact: Mariano Provencio, MD, PhD    +34 91 191 416280    mprovencio.ensayosclinicos@gmail.com   
Contact: Sandra Cerdeira       scerdeira.hpth@salud.madrid.org   
Principal Investigator: Mariano Provencio, MD, PhD         
Hospital Universitario Málaga Regional. IBIMA Recruiting
Málaga, Spain
Contact: Manuel Cobo, MD    +34 95 129 14 25    manuelcobodols@yahoo.es   
Contact: Alicia Medina    +34 95 129 14 25    alicia.medina@ibima.eu   
Principal Investigator: Manuel Cobo, MD         
Sponsors and Collaborators
NovoCure Ltd.
  More Information

Publications:
Giladi M, Voloshin T, Shteingauz A, Munster M, Blat R, Porat Y, Schneiderman RS, Cahal S, Itzhaki A, Kirson E, Weinberg U, Palti Y. Alternating electric fields (TTFields) induce immunogenic cell death resulting in enhanced antitumor efficacy when combined with anti-PD-1 therapy. J Immunol. 2016;196(1 Supplement):75.26-75.26.

Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT02973789     History of Changes
Other Study ID Numbers: EF-24
First Submitted: November 22, 2016
First Posted: November 25, 2016
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by NovoCure Ltd.:
Novocure
Non-Small Cell Lung Cancer
NSCLC
Treatment
Minimal Toxicity
TTFields
TTF
Tumor Treating Fields
Docetaxel
PD-1 inhibitor
PD-L1 inhibitor
Immune checkpoint inhibitor

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action