194TiP - LUNAR: Phase III study of front-line chemotherapy with TTFields for advanced squamous NSCLC

Date 15 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session Poster lunch
Topics Cytotoxic agents
Non-small-cell lung cancer
Therapy
Biological therapy
Presenter Uri Weinberg
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors U. Weinberg1, O. Farber2, M. Giladi2, Z. Bomzon2, E.D. Kirson2
  • 1Research & Development, Novocure GmbH, 6039 - Root/CH
  • 2R&d, Novocure Ltd., 30004 - Haifa/IL

Abstract

Background

Tumor Treating Fields (TTFields) is a novel, non-invasive, anti-mitotic treatment modality, based on low intensity alternating electric fields. TTFields predominantly affect two phases of mitosis: metaphase – by disrupting the formation of the mitotic spindle, and cytokinesis – by dielectrophoretic dislocation of intracellular constituents. Efficacy of TTFields in non-small cell lung cancer (NSCLC) of all histologies has been demonstrated multiple in vitro and in vivo models, as well as in a phase I/II pilot study, in combination with pemetrexed.

Trial design

300 patients with advanced NSCLC of squamous histology will be randomized in a ratio of 1:1 to receive either standard doublet chemotherapy alone or chemotherapy combined with TTFields. Patients are followed-up every 6 weeks clinically and radiographically until intra-thoracic progression. Objectives: To test the efficacy and safety of TTFields in combination with chemotherapy in this patient population. Endpoints: OS (primary), radiological response, progression free survival, in field vs. out of field time to progression, quality of life and safety (secondary). Statistical Considerations: This is prospective, randomized, multicenter study for 300 patients. The total sample size will achieve an 80% power with an alpha of 0.05 using a two-sided log rank test to detect a hazard ratio of 0.69 for OS. Patients will be stratified based on presence/absence of extra-thoracic disease, gender and region. Key Eligibility Criteria: Age >18 years; Intra-thoracic advanced NSCLC with squamous histology; No prior chemotherapy or biological therapy for advanced disease; No prior intra-thoracic radiotherapy for advanced disease; ECOG performance status of 0–1; No serious co-morbidities; No contraindication for chemotherapy or TTFields; Adequate bone marrow, liver and renal functions. Treatment: Continuous, daily TTFields Therapy at 150 kHz, applied to the thorax using the NovoTTF-100L System. The System is a portable medical device allowing normal daily life activities. The device delivers alternating electric fields to the thorax using 4 Transducer Arrays. Chemotherapy options include a taxane or gemcitabine platinum-based doublet.

Clinical trial identification

not assigned yet

Legal entity responsible for the study

Novocure Ltd.

Funding

Novocure Ltd.

Disclosure

U. Weinberg, O. Farber, M. Giladi, Z. Bomzon, E.D. Kirson: Novocure employee.