Phase III trial tests TTFields plus standard therapy for stage 4 NSCLC after platinum failure

Status: COMPLETED | Phase: PHASE3 Condition(s): Nonsmall Cell Lung Cancer, NSCLC Intervention(s): NovoTTF-200T (DEVICE), Immune checkpoint inhibitors or docetaxel (DRUG) The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-200T device, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment. 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. Detailed: 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 and PD-1 inhibitors. TTFields have been demonstrated to act synergistically with taxanes and have been shown to be additive when combined with PD-1 inhibitors. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment. In a pilot study, 42 patients with advanced NSCLC who had 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 Primary Outcome(s): Overall Survival of Patients Treated With TTFields + Docetaxel or Immune Checkpoint Inhibitors vs. Docetaxel or Immune Checkpoint Inhibitors Alone (Superiority Analysis) Enrollment: 291 (ACTUAL) Lead Sponsor: NovoCure GmbH Start: 2016-12 | Primary Completion: 2024-09-24 Results posted: 2026-03-18