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Protocol No. UW17149

Principal Investigator Leal, Ticiana

Phase III

Age Group Adult

Scope National

Sponsor Type Industry

Title 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

Objective We want to find out if an investigational device called NovoTTF-100L, in combination with standard medication (chemotherapy or immunotherapy), is a better treatment for non-small cell lung cancer (NSCLC) that progressed after receiving chemotherapy containing platinum than treatment with standard of care alone. Investigational means that the US Food and Drug Administration (FDA) has not approved this device (NovoTTF-100L) for treatment of nonsmall cell lung cancer, and the device can only be used in a research study

Treatment People in this study will be assigned by chance to get either the investigational device, NovoTTF-100L in combination with standard care treatment, or the standard care treatment alone

Description Tumor Treating Fields Conccurent with SOC Treatment for NSCLC Post-Platinum

Key Eligibility
  • 22 years of age and older
  • Life expectancy of > 3 months
  • Histological diagnosis of squamous or non-squamous, inoperable, stage 4 NSCLC
  • Diagnosis of radiological progression while on or after first platinum-based systemic therapy
  • ECOG Score of 0-2
  • Assigned by the physician to receive either docetaxel or immune checkpoint inhibitor perstandard of care regimens
  • Able to operate the NovoTTF-100L device independently or with the help of a caregiver
  • No presence of brain metastasis or leptomeningeal spread of the disease
  • Adequate hematological, hepatic and renal function
  • No history of significant cardiovascular disease unless the disease is well controlled
  • No history of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded
  • No history of pericarditis
  • No history of interstitial lung disease
  • No active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy
  • No implantable electronic medical devices (e.g. pacemaker, defibrilator) in the upper torso
  • No known allergies to medical adhesives or hydrogel
  • Can not be pregnancy or breast-feeding (patients with reproductive potential must use effective contraception methods throughout the entire study period

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions UW Hospital and Clinics