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. TTFields have also shown to inhibit metastatic spread of
      malignant melanoma in in vivo experiment.

      In a pilot study, 42 patients with advanced NSCLC who 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). 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).

      Applying TTFields at 150 kHz to the brain for the treatment of 1-5 brain metastasis from
      NSCLC using the NovoTTF-100M device has been demonstrated to be safe in a pilot study, where
      patients were randomized after local therapy of their brain metastasis by neurosurgery and/or
      stereotactic radiosurgery to receive either NovoTTF-100M treatment or supportive care alone.
      Eighteen (18) patients have been enrolled in the study. There have been no device-related
      serious adverse events (SAE) reported to date (Brozova H., et al., Neuro Oncol 2016).

      DESCRIPTION OF THE TRIAL:

      All patients included in this trial are patients with 1-10 brain metastases from NSCLC which
      are amenable to stereotactic radiosurgery (SRS). In addition, all patients must meet all
      eligibility criteria.

      Eligible patients will be randomly assigned to one of two groups:

        1. Patients undergo SRS followed by TTFields using the NovoTTF-100M System

        2. Patients undergo SRS alone and receive supportive care.

      Patients in both arms of the study may receive systemic therapy for their NSCLC at the
      discretion of their treating physician.

      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-100M group, the patients will be treated
      continuously with the device until second intracranial progression.

      On both arms, patients who recur anywhere in the brain will be offered one of the following
      salvage treatments (according to local practice) including, but not limited to:

        -  Surgery

        -  Repeat SRS

        -  Whole brain radiotherapy (WBRT)

      Patients on the control arm will be offered to cross over to the NovoTTF-100M arm of the
      study and receive TTFields after salvage therapy for second intracranial progression if the
      investigator believes it is in the best interest of the patient and patient agrees.

      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 brain
      metastases from NSCLC with very few side effects.