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Trial record 2 of 23 for:    novocure

Effect of Tumor Treating Fields (TTFields) (150 kHz) as Second Line Treatment of Non-small Cell Lung Cancer (NSCLC) in Combination With PD-1 Inhibitors or Docetaxel (LUNAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by NovoCure Ltd.
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.
ClinicalTrials.gov Identifier:
NCT02973789
First received: November 22, 2016
Last updated: March 23, 2017
Last verified: February 2017
  Purpose
The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with PD-1 inhibitors or docetaxel, for second line treatment of Non-small Cell Lung Cancer (NSCLC) .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: PD1 inhibitors or docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: LUNAR: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields) (150 kHz) in Combination With PD-1 Inhibitors or Docetaxel, for Second Line Treatment of Non-small Cell Lung Cancer (NSCLC)

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 PD-1 inhibitors vs. docetaxel or PD-1 alone (superiority) [ Time Frame: 4 years ]
  • Co-primary outcome (will be tested only if the primary endpoint fails): Overall survival of patients treated with TTFields + docetaxel vs. PD-1 inhibitors alone (non-inferiority) [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • Overall survival of patients treated with TTFields + docetaxel vs. docetaxel alone (superiority) [ Time Frame: 4 years ]
  • Overall survival of patients treated with TTFields + PD-1 inhibitors vs. PD- 1 inhibitors alone (superiority) [ Time Frame: 4 years ]
  • Progression-free survival of patients treated with docetaxel or PD-1 inhibitors + TTFields vs. docetaxel or PD-1 inhibitors alone, based on the Immune-Related Response Criteria (irRC) [ Time Frame: 4 years ]
  • Best overall radiological response rate (based on Immune-Related Response Criteria (irRC)) of patients treated with TTFields + docetaxel or PD-1 inhibitors vs. docetaxel or PD-1 inhibitors alone [ Time Frame: 4 years ]
  • Quality of life of patients treated with TTFields+ docetaxel or PD-1 inhibitors vs. docetaxel or PD-1 inhibitors alone, using the EORTC QLQ C30 questionnaire with LC13 addendum [ Time Frame: 4 years ]
  • Adverse events, severity and frequency, in patients treated with TTFields+ docetaxel or PD-1 inhibitors vs. docetaxel or PD-1 inhibitors alone [ Time Frame: 4 years ]

Estimated Enrollment: 512
Study Start Date: December 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NovoTTF-100L
Patients receive TTFields using the NovoTTF-100L System together with PD1 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: PD1 inhibitors or docetaxel
Patients receive standard of care with PD1 inhibitors or docetaxel
Active Comparator: Best Standard of Care
Patients receive best standard of care with PD1 inhibitors or docetaxel
Drug: PD1 inhibitors or docetaxel
Patients receive standard of care with PD1 inhibitors or docetaxel

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age and older
  2. Life expectancy of ≥ 3 months
  3. Histological diagnosis of squamous or non-squamous, unresectable, locally advanced or metastatic NSCLC
  4. Diagnosis of first radiological progression according to RECIST Criteria V1.1 while on or after front-line treatment, within 14 days of randomization
  5. ECOG Score of 0-1
  6. Assigned by the physician to receive either docetaxel or PD-1 inhibitor per standard of care regimens
  7. Able to operate the NovoTTF-100L device independently or with the help of a caregiver
  8. Signed informed consent for the study protocol

Exclusion Criteria:

  1. Presence of brain metastasis or leptomeningeal spread of the disease
  2. Prior surgery or radiation therapy in the lungs (except for palliation purposes)
  3. 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 cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable
    5. Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy
    6. 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
    7. 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
  4. Concurrent treatment with other experimental treatments for NSCLC while on the study
  5. Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso
  6. Known allergies to medical adhesives or hydrogel
  7. Pregnancy or breast-feeding (patients with reproductive potential must use effective contraception methods throughout the entire study period, as determined by their investigator/gynecologist)
  8. Admitted to an institution by administrative or court order
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02973789

Contacts
Contact: Birgit Allmendinger BAllmendinger@novocure.com

Locations
Czech Republic
Vitkovicka nemocnice Recruiting
Vitkovice, Czech Republic
Contact: Jaromir Roubec       jaromir.roubec@vtn.agel.cz   
Contact: Zuzana Gerlochová    +42 0595633175    zuzana.gerlochova@ymail.com   
Principal Investigator: Jaromir Roubec         
Poland
Uniwersyteckie Centrum Kliniczne Recruiting
Gdansk, Poland
Contact: Ewa Szutowicz-Zielinska, MD    +48 583492271      
Principal Investigator: Ewa Szutowicz-Zielinska, MD         
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         
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
Study First Received: November 22, 2016
Last Updated: March 23, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

ClinicalTrials.gov processed this record on April 26, 2017