Author of

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  Lunch & Poster Display session (ID 58)

  • Event: ELCC 2019
  • Type: Poster Display session
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1

  • 29121

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    187TiP - Tumor treating fields concurrent with standard of care therapy for stage IV NSCLC following platinum failure: Phase III LUNAR study (ID 391)

    12:30 - 13:00  |  Author(s): Ori Farber
    • Abstract
    • Slides

    Background
    

    Tumor Treating Fields (TTFields), a non-invasive anti-mitotic treatment, added to temozolomide significantly extended survival in newly diagnosed glioblastoma. TTFields is eficacious in preclinical in vitro and in vivo NSCLC models. A phase I/II study [NCT00749346] of advanced NSCLC of TTFields plus pemetrexed detected no serious adverse events; median overall survival (OS) of 13.8 months. The Phase 3 LUNAR study [NCT02973789] investigates if TTFields added to immune checkpoint inhibitors or docetaxel following platinum failure will increase overall survival (OS).

    a9ded1e5ce5d75814730bb4caaf49419 Trial design
    

    Patients (N = 534) with squamous or non-squamous NSCLC, are stratified by therapy (immune checkpoint inhibitors or docetaxel), histology (squamous vs. non-squamous) and geographical region. Key inclusion criteria: disease progression on or after platinum-based therapy, ECOG 0-2, no electronic medical devices in upper torso, and absence of brain metastases. Docetaxel or immune checkpoint inhibitors are given at standard doses. TTFields (150 kHz) are applied to the upper torso for >18 hours/day. TTFields are continued until progression in the thorax and/or liver. Follow up is performed once q6 weeks, including CT scans of the chest and abdomen. On progression in the thorax and/or liver, patients have 3 post-progression follow up visits and are then followed monthly for survival. The primary endpoint is superiority in OS between patients treated with TTFields in combination with the standard of care treatments versus standard of care treatments alone. Key secondary endpoints compare the OS in patients treated with TTFields and docetaxel versus docetaxel alone, and patients treated with TTFields and immune checkpoint inhibitors vs those treated with immune checkpoint inhibitors alone. An exploratory analysis will test non-inferiority of TTFields with docetaxel compared to checkpoint inhibitors alone. Secondary endpoints include progression-free survival, radiological response rate, quality of life based on the EORTC QLQ C30 questionnaire and severity and frequency of adverse events. The sample size is powered to detect a HR of 0.75 in TTFields-treated patients versus control group.

    d9b324a48b043b3d87bc9b3fe620f260 Clinical trial identification
    

    NCT02973789.

    7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study
    

    Novocure.

    213f68309caaa4ccc14d5f99789640ad Funding
    

    Novocure.

    682889d0a1d3b50267a69346a750433d Disclosure
    

    U. Weinberg, O. Farber, M. Giladi, Z. Bomzon, E. Kirson: Full time employee, stock options: Novocure.

    cffcb1a185b2d7d5c44e9dc785b6bb25

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