Study Design
LUNAR: A phase 3 clinical study comparing the OS benefit in Optune Lua + IOs/docetaxel vs either agent alone1,2
Stratification1
- IO vs docetaxel
- Histology (squamous vs nonsquamous)
- Geographic region
Study sites1
- 130 (North America, Europe, and Asia)
Primary endpoint1
- OS with Optune Lua + IO or docetaxel vs IO or docetaxel alone
Key secondary endpoints1
- OS in subpopulations receiving either docetaxel or an IO
*After the interim analysis, the independent data monitoring committee recommended reducing patient accrual to 276 patients with 12 months follow-up.3
Initial accrual was 534 patients with 18 months follow-up. The expected hazard ratio for overall survival is <0.75.1
†Nivolumab, pembrolizumab, or atezolizumab.1
Baseline characteristics: Well balanced across both arms of the study1,3
- % of patients receiving prior IO
- Optune Lua + docetaxel subgroup: 59%
- Optune Lua + IO subgroup: 2%
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†PD-L1 status reporting was optional and was available for 83% of patients in the United States.4
‡One patient had liver and brain metastasis.1
§Patients with brain metastases were excluded under the original study design; later amended to allow stable brain metastases.1
aNSCLC, advanced non-small cell lung cancer; CT, computed tomography; ECOG PS, Eastern Cooperative Oncology Group performance status; EORTC, European Organisation for Research and Treatment of Cancer; IO, immuno-oncology agent; OS, overall survival; PD-L1, programmed cell death ligand 1; Q6W, every 6 weeks.
References: 1. Leal T, Kotecha R, Ramlau R, et al. Tumor treating fields therapy with standard systemic therapy versus standard systemic therapy alone in metastatic non-small-cell lung cancer following progression on or after platinum-based therapy (LUNAR): a randomised, open-label, pivotal phase 3 study. Lancet Oncol. 2023;24(9):1002-1017. doi:10.1016/S1470-2045(23)00344-3 2. Leal T, Kotecha R, Ramlau R, et al. Tumor treating fields therapy with standard systemic therapy versus standard systemic therapy alone in metastatic non-small-cell lung cancer following progression on or after platinum-based therapy (LUNAR): a randomised, open-label, pivotal phase 3 study. Supplementary appendix. Lancet Oncol. 2023;24(9):1002-1017. doi:10.1016/S1470-2045(23)00344-3 3. Optune Lua. Instructions for Use for non small cell lung cancer. Novocure; 2023. 4. Leal T, Kotecha R, Ramlau R, et al. Tumor treating fields (TTFields) therapy with standard of care (SOC) in metastatic non-small cell lung cancer (mNSCLC) after platinum-based therapies: randomized, phase 3 LUNAR study. Presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL. Abstract LBA9005.