First Patient Enrolled in Novocure’s Phase 3 Pivotal LUNAR Trial Testing Tumor Treating Fields for the Treatment of Advanced Non-Small Cell Lung Cancer After Failing Platinum-Based Therapy
The trial will test the efficacy and safety of TTFields at 150 kHz in combination with two of the current standard of care treatments, immune checkpoint inhibitors or docetaxel
ST. HELIER, Jersey–(BUSINESS WIRE)–
The international trial is planned to include 512 patients with stage IIIB and IV NSCLC of all histologies after failing platinum-based therapy. The primary endpoint is superior overall survival of patients treated with TTFields plus immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone. In addition, the trial will test non-inferiority in overall survival of patients treated with TTFields plus docetaxel versus immune checkpoint inhibitors alone.
“We designed this trial to test TTFields with two of the currently available standard of care treatments for advanced NSCLC following failure of platinum-based therapy, opening the trial to more patients with this disease,” said Dr.
The LUNAR trial design was based on preclinical findings that suggest TTFields may act synergistically with certain taxanes and enhance the efficacy of immune checkpoint inhibitors. In addition, the trial design was informed by Novocure’s phase 2 pilot EF-15 trial1, which tested TTFields at 150 kHz in combination with pemetrexed chemotherapy in 42 patients with advanced second- or subsequent-line NSCLC. The EF-15 study showed that TTFields are safe and tolerable in patients with advanced NSCLC. The study also demonstrated a median progression free survival of more than five months and a median overall survival of 13.8 months. These results exceeded historical results for second-line treatment of advanced NSCLC with pemetrexed chemotherapy alone. Notably, the EF-15 trial also included patients with squamous histology (n=7, 17 percent), who typically do not respond to treatment with pemetrexed.
“The start of LUNAR, our second ongoing phase 3 trial beyond glioblastoma, further demonstrates our commitment to testing TTFields across a variety of solid tumor cancers and bringing our therapy to patients who may benefit from it,” said
For more information on the trial design, visit ClinicalTrials.gov.
About Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer-related death in
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1 Pless M. et al., A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Jul 23. pii: S0169-5002(13)00308-5. doi: 10.1016
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