Abstract CT173: Tumor Treating Fields (150 kHz) concurrent with standard of care treatment for stage 4 non-small cell lung cancer (NSCLC) following platinum failure: The Phase III LUNAR study

Abstract

Abstract Background Tumor Treating Fields (TTFields) is a non-invasive, anti-mitotic treatment that disrupts the formation of the mitotic spindle and dislocation of intracellular constituents. TTFields plus temozolomide significantly extended survival in newly diagnosed glioblastoma. Efficacy of TTFields in NSCLC has been shown in preclinical in vitro and in vivo models. In a Phase I/II pilot study [NCT00749346} of advanced NSCLC, TTFields in combination with pemetrexed detected no serious adverse events and median overall survival (OS) was 13.8 months. In the Phase III LUNAR study [NCT02973789], we investigated if the addition of TTFields to immune checkpoint inhibitors or docetaxel following platinum doublet failure will increase overall survival (OS). Methods 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 (150 kHz) 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 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. Citation Format: Uri Weinberg, Ori Farber, Moshe Giladi, Zeev Bomzon, Eilon Kirson. Tumor Treating Fields (150 kHz) concurrent with standard of care treatment for stage 4 non-small cell lung cancer (NSCLC) following platinum failure: The Phase III LUNAR study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT173.