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Trial record 2 of 22 for:    novocure

Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by NovoCure Ltd.
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.
ClinicalTrials.gov Identifier:
NCT02831959
First received: July 8, 2016
Last updated: November 7, 2016
Last verified: November 2016
  Purpose
The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. 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
Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
Device: NovoTTF-100M device
Other: Best Standard of Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) (150kHz) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:
  • Time to first cerebral progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to neurocognitive failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measured by cognitive decline on a battery of tests: Hopkins Verbal Learning Test (HVLT-R) free recall, delayed recall, and delayed recognition; Controlled Oral Word Association Test (COWAT); and Trail Making Tests (TMT) Parts A and B

  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Radiological response in the brain [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Time to second cerebral progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Time to first and second cerebral progression evaluated in two cohorts, 1-4 brain metastases and 5-10 brain metastases. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Rate of cerebral progression at 2, 4, 6, 8, 10, 12 months [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Intracranial progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Time to distant progression in the supratentorial region [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Rate of decline in cognitive function at 2, 4, 6, 8, 10, 12 months [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Measured by HVLT-R free recall, delayed recall, and delayed recognition; COWAT; and TMT Parts A and B

  • Neurocognitive failure-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Defined from the date of first SRS treatment to neurocognitive failure (as measured by HVLT-R free recall, delayed recall, and delayed recognition; COWAT; and TMT Parts A and B) or death (whichever occurs first), censored at the last neurocognitive assessment on which the patient was reported alive without neurocognitive failure

  • Quality of Life using the EORTC QLQ C30 with BN20 addendum [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Toxicity during NovoTTF-100M treatment based on incidence and severity of treatment emergent adverse events as evaluated using the CTCAE version 4.0 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 270
Study Start Date: July 2016
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NovoTTF-100M device
Patients undergo SRS followed by continuous TTFields treatment using the NovoTTF-100M device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.
Device: NovoTTF-100M device
Active Comparator: Best Standard of Care
Patients will undergo SRS alone and be treated with the best known standard of care for Non-Small Cell Lung Cancer metastatic to the brain.
Other: Best Standard of Care

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. 18 years of age and older
  2. Life expectancy of ≥ 3 months
  3. New diagnosis of brain metastases from a histologically or cytologically confirmed primary or metastatic NSCLC tumor within 5 years of registration on the study. If the original histological proof of malignancy is greater than 5 years, then pathological confirmation is required (i.e.: from extra-cranial or intracranial disease).
  4. Karnofsky performance status (KPS) ≥ 70
  5. Graded Prognostic Assessment (GPA) score ≥ 2.0
  6. 1 inoperable brain metastasis or 2- 10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to the following criteria:

    1. largest tumor volume < 10 cc
    2. longest tumor diameter < 3 cm
    3. Cumulative volume of all tumors ≤ 15 cc
  7. At least one measurable lesion per RANO-BM (Response Assessment in Neuro-Oncology Brain Metastases) Criteria for brain metastasis
  8. Patients must be receiving optimal therapy for their extracranial disease according to local practice at each center. Patients may continue on systemic therapy while receiving TTFields.
  9. Able to operate the NovoTTF-100M device independently or with the help of a caregiver
  10. Clinical trials prior to enrollment are allowed, as long as no brain directed therapy was included (current treatment trials are exclusionary)

Exclusion Criteria:

  1. Patients who are known to have somatic tumor mutations in the following genes, for which targeted agents are available that directly affect the treatment of brain metastasis: Anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), ROS-1 proto-oncogene, and proto-oncogene B-RAF
  2. Patients who have a single, operable brain metastasis
  3. Patients with significant edema leading to risk of brain herniation
  4. Patients with midline shift > 10mm
  5. Patients with intractable seizures
  6. Infratentorial metastases
  7. Leptomeningeal metastases
  8. Recurrent brain metastases or brain metastases previously treated with surgery and/or radiosurgery and/or brain radiotherapy
  9. Prior surgical resection or WBRT for newly diagnosed brain metastases (needle biopsy for diagnosis establishment is allowed)
  10. Severe comorbidities:

    1. Clinically-significant inadequate hematological, hepatic and renal function, defined as: Neutrophil count < 1.5 x 10 9/L and platelet count < 100 x 10^9/L; bilirubin > 1.5 x upper limit of normal (ULN); aspartate transaminase (AST) and/or alanine aminotransferase (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
  11. Implantable electronic medical devices in the brain
  12. Known allergies to medical adhesives or hydrogel
  13. Currently pregnant or breastfeeding
  14. Concurrent brain directed therapy (beyond SRS and NovoTTF-100M as per protocol)
  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: NCT02831959

Contacts
Contact: Ghazala Kabani patientinfo@novocure.com

  Hide Study Locations
Locations
United States, California
Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Felix Luz    310-423-5379    Luz.Felix@cshs.org   
Principal Investigator: Jethro Hu, MD         
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange Not yet recruiting
Orange, California, United States, 92868
Contact: Ron Bati    714-734-6200 ext 40888    Lavinia.Dobrea@stjoe.org   
Principal Investigator: Venita Williams, MD         
United States, Connecticut
Associated Neurologists of Southern CT Recruiting
Fairfield, Connecticut, United States, 06824
Contact: Micah Sy    203-333-1151    MSy@anscneuro.com   
Principal Investigator: Nicholas Blondin, MD         
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Kris Wynne    352-273-9727    Kristine.Wynne@neurosurgery.ufl.edu   
Principal Investigator: David Tran, MD         
Miami Cancer Institute Not yet recruiting
Miami, Florida, United States, 33176
Contact: Jessica Gonzalez-Salas    786-527-8112    jessicag1@baptisthealth.net   
Principal Investigator: Minesh Mehta, MD         
United States, Georgia
Piedmont Brain Tumor Center Recruiting
Atlanta, Georgia, United States, 30309
Contact: Shirley Elkins    404-605-2050    Shirley.Elkins@piedmont.org   
Principal Investigator: Adam Nowlan, MD         
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Ann Mendelke    312-695-1383    anne.mendelke@northwestern.edu   
Principal Investigator: Priya Kumthekar, MD         
The University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Gabe Pugel    773-702-5928    gpugel@bsd.uchicago.edu   
Principal Investigator: Rimas Lukas, MD         
CDH-Delnor Health System Recruiting
Warrenville, Illinois, United States, 60555
Contact: Donald Smith, MS, CCRC    603-352-5360    Donald.Smith@CadenceHealth.Org   
Principal Investigator: Vinai Gondi, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Erika Hargis    502-217-5244    erika.hargis@louisville.edu   
Principal Investigator: Eric Burton, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Amy Quinkert    617-636-8589    aquinkert@tuftsmedicalcenter.org   
Principal Investigator: Suriya Jeyapalan, MD         
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Janlyn Murphy    617-667-1832    jmurphy7@bidmc.harvard.edu   
Principal Investigator: Eric Wong, MD         
United States, Minnesota
John Nasseff Neuroscience Institute ANW Brain Tumor Center Not yet recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Amy Schrecengost    612-863-6562    Amy.Schrecengost@Allina.com   
Principal Investigator: John Trusheim, MD         
Masonic Cancer Clinic Not yet recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Almarie Coleman    612-624-5949    colem258@umn.edu   
Principal Investigator: Emil Lou, MD         
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Justin Buroker    507-293-0624    Buroker.Justine@mayo.edu   
Principal Investigator: Daniel Ma, MD         
United States, New York
Weil Cornell Medical College/New York Presbyterian Hospital Recruiting
New York, New York, United States, 10021
Contact: Amanda De Laurentiis    646-962-9349    amd9041@med.cornell.edu   
Principal Investigator: Ronald Scheff, MD         
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Principal Investigator: Isabelle Germano, MD         
United States, North Carolina
East Carolina University Not yet recruiting
Greenville, North Carolina, United States, 27834
Contact: Kaitlyn Walker    252-744-0456    WALKERKAI16@ECU.EDU   
Principal Investigator: Clinton Leinweber, MD         
Wake Forest Health Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Shirley Coe    336-713-6505    scoe@wakehealth.edu   
Contact: Jennifer Black    336-716-9342    jhblack@wakehealth.edu   
Principal Investigator: Michael Chan, MD         
United States, Pennsylvania
Geisinger Medical Center Not yet recruiting
Danville, Pennsylvania, United States, 17822
Contact: Chelsie Derr    570-271-6590    cmderr1@geisinger.edu   
Principal Investigator: Scott Turner, MD         
Fox Chase Cancer Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Tracy Tradzinski    215-214-1546    Tracy.Tradzinkski@fccc.edu   
Principal Investigator: Stephanie Weiss, MD         
United States, Tennessee
West Cancer Center Recruiting
Germantown, Tennessee, United States, 38138
Contact: Rachel Adams, CCRP    910-683-0055 ext 63005    raadams@westclinic.com   
Principal Investigator: Matthew Ballo, MD         
United States, Texas
The University of Texas M.D. Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Victoria Cox    713-792-4928    vcox@mdanderson.org   
Principal Investigator: Jing Li, MD         
Joe Arrington Cancer Research and Treatment Center Not yet recruiting
Lubbock, Texas, United States, 79410
Contact: Sonia Salas    806-725-8068    ssalas@covhs.org   
Principal Investigator: Paul Anderson, MD         
Scott and White Not yet recruiting
Temple, Texas, United States, 76508
Contact: Dedra Preece, CRC    254-771-4826    dedra.preece@bswhealth.org   
Principal Investigator: Ekokobe Fonkem, MD         
United States, Virginia
University of VA Health Sciences Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Joe Farrar, BS    434-982-6455    jcf6k@hscmail.mcc.virginia.edu   
Principal Investigator: Jason Jason Sheehan, MD         
Sentara Health Not yet recruiting
Norfolk, Virginia, United States, 23507
Contact: Rebecca M Lee    757-388-4393    rmlee1@sentara.com   
Principal Investigator: Wylie Zhu, MD         
Canada, Quebec
Jewish General Hospital Not yet recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Thierry Muanza    (514)-340-8288    tmuanza@yahoo.com   
Principal Investigator: Thierry Muanza, MD         
Hôpital Maisonneuve-Rosemont Not yet recruiting
Montréal, Quebec, Canada, H1T-2M4
Contact: Linda Roy-Huneault    (514)-252-3400 ext 3227    lroyhuneault.hmr@ssss.gouv.qc.ca   
Principal Investigator: Pierre Chabot, MD         
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS) Not yet recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Anick Champous    (819)-346-1110 ext 12811    achampoux.chus@ssss.gouv.qc.ca   
Principal Investigator: David Mathieu, MD         
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Principal Investigator: Minesh Mehta, MD Miami Cancer Institute, Miami FL USA
Principal Investigator: Paul Brown, MD MD Anderson Cancer Center, Houston TX USA
Principal Investigator: Vinai Gondi Northwestern Medicine Cancer Center, Warenville IL USA
  More Information

Publications:
Brozova H, Lucas A, Salmaggi A, Vymazal J. COMET: A phase II randomized study of TTFields versus supportive care in non-small cell lung cancer patients with 1-5 brain metastases - initial safety results. Neuro Oncol. 2015 Nov; 17 (suppl 5): v46. doi:10.1093/neuonc/nov208.6

Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT02831959     History of Changes
Other Study ID Numbers: EF-25 
Study First Received: July 8, 2016
Last Updated: November 7, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by NovoCure Ltd.:
Novocure
Non-Small Cell Lung Cancer
NSCLC
Brain metastases
Treatment
Minimal toxicity
TTFields
TTF
Tumor Treating Fields
SRS
Stereotactic radiosurgery

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on December 02, 2016