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Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Presentations: 1
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
199TiP - TTFields concurrent with standard of care for stage 4 non-small cell lung cancer (NSCLC) following platinum failure: Phase 3 LUNAR study (ID 523)
12:30 - 13:00 | Author(s): Z. Bomzon
Tumor Treating Fields (TTFields) is a non-invasive, anti-mitotic treatment that disrupt the formation of the mitotic spindle and dislocation of intracellular constituents. TTFields plus temozolomide significantly extend survival in newly diagnosed glioblastoma. Efficacy of TTFields in NSCLC has been shown preclinically and their safety in a phase I/II pilot study with pemetrexed. We hypothesize that adding TTFields to immune checkpoint inhibitor or docetaxel following platinum doublet failure will increase OS.
Patients (N = 534), with squamous or non-squamous NSCLC, are stratified by their selected standard therapy (immune checkpoint inhibitors or docetaxel), histology (squamous vs. non-squamous) and geographical region. Key inclusion criteria are disease progression while on or after platinum-based therapy, ECOG 0-2, no electronic medical devices in the upper torso, and absence of brain metastasis. Docetaxel or immune checkpoint inhibitors are given at standard doses. TTFields are applied to the upper torso for at >18 hours/day, allowing patients to maintain daily activities. 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 (vs) standard of care treatments alone. Key secondary endpoints compare the OS in patients treated with TTFields and docetaxel vs 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 & frequency of adverse events. The sample size is powered to detect a HR of 0.75 in TTFields-treated patients versus control group.
Clinical trial identification:
Legal entity responsible for the study:
U. Weinberg, O. Farber, M. Giladi, Z. Bomzon, E. Kirson: Novocure employee
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