Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer

February 21, 2018

EF-25: Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

  • Clinical Trial Information

    Trial Contact: Manchola-Orozco, Carolina; Walton, Sherri

    Trial Phone: 321.841.7293 ; 321.841.1907

  • IRB No: 17.065.06

    Protocol Abbrev: Novocure EF-25

    Principal Investigator: Naren Ramakrishna, MD, PhD

    Phase: Device: Significant Risk

    Age Group: Adult

    Secondary Protocol No: EF-25

    Treatment: administration of alternating electric fields to the region of the malignant tumor

    Therapies Involved: Radiation

    ClinicalTrials.gov ID: NCT02831959

  • Objective

    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.

  • Key Eligibility

    Ages Eligible for Study: 18 Years and older (Adult, Senior)
    Sexes Eligible for Study: All

    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:
    a.largest tumor volume < 10 cc
    b.longest tumor diameter < 3 cm
    c.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)