Effect of TTFields in Non-small Cell Lung Cancer

LUNAR: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields) concurrent with standard of care therapies for treatment of stage 4 non-small cell lung cancer (NSCLC) following platinum failure

  • Clinical Trial Information

    Trial Contact: De Leon, Ma Theresa; Deronvil, France

    Trial Phone: 321.841.8284 ; 321.841.3498

  • IRB No: 18.141.10

    Protocol Abbrev: Lunar EF-24

    Principal Investigator: Jennifer E. Tseng, MD

    Phase: Device: Significant Risk

    Age Group: Adult

    Secondary Protocol No: EF-24

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

    Therapies Involved: Radiation ID: NCT02973789

  • Objective

    To test the efficacy and safety of TTFields, using the NovoTTF-100L System, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment.

  • Key Eligibility

    1.22 years of age and older
    2.Life expectancy of ≥ 3 months
    3.Histological diagnosis of squamous or non-squamous, inoperable, stage 4 NSCLC
    4.Diagnosis of radiological progression while on or after first platinum-based systemic therapy
    5.Randomization within 28 days of diagnosis of last progression
    6.ECOG Score of 0-2
    7.Assigned by the physician to receive either docetaxel or immune checkpoint inhibitor per standard of care regimens
    8.Able to operate the NovoTTF-100L device independently or with the help of a caregiver
    9.Signed informed consent for the study protocol