Study Design

Optune Lua + PD-1/PD-L1 inhibitor or docetaxel vs either agent alone1,2

LUNAR was a phase 3, open-label, randomized study of nearly 300 patients with 2L+ mNSCLC1

Stratification1

  • PD-1/PD-L1 inhibitor vs docetaxel
  • Histology (squamous vs nonsquamous)
  • Geographic region

Primary endpoint1

  • OS with Optune Lua + PD-1/PD-L1 inhibitor or docetaxel vs PD-1/PD-L1 inhibitor or docetaxel alone

Study sites1

  • 68 (United States, Europe, China, and Canada)

Key secondary endpoints1

  • OS in subpopulations receiving either docetaxel or a PD-1/PD-L1 inhibitor alone

Baseline characteristics were well balanced across both arms of the study1

*Patients with brain metastases were excluded under the original study design, later amended to allow stable brain metastases.4
†After interim analysis, the independent data monitoring committee recommended reducing patient accrual to 276 patients with 12 months follow-up. Initial planned accrual was 534 patients with 18 months follow-up. The final enrollment was 291. The expected hazard ratio for overall survival was <0.75.1,5
‡Nivolumab, pembrolizumab, or atezolizumab, as assigned by the physician.1
§PD-L1 status reporting was optional and was available for 83% of patients in the United States.3
||One patient had liver and stable brain metastases.3

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Review patient profiles

2L+, second line or after; CNS, central nervous system; CT, computed tomography; ECOG PS, Eastern Cooperative Oncology Group performance status; IO, immuno-oncology agent (nivolumab, pembrolizumab, or atezolizumab); mNSCLC, metastatic non–small cell lung cancer; MRI, magnetic resonance imaging; OS, overall survival; PD-1/PD-L1, programmed cell death 1 protein/programmed cell death 1 ligand 1; Q6W, every 6 weeks; R, randomized.

 

References: 1. Optune Lua for Non-Small Cell Lung Cancer (NSCLC). Physician Instructions for Use. Novocure; 2024. 2. Novocure Data on File US-DOF-0046. 3. Novocure Data on File GLB-DOF-0020. 4. Leal T, Kotecha R, Ramlau R, et al. Lancet Oncol. 2023;24(9):1002-1017. 5. Leal T, Kotecha R, Ramlau R, et al. Supplementary appendix. Lancet Oncol. 2023;24(9):1002-1017. Accessed March 21, 2024. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00344-3/fulltext

Important Safety Information 

Contraindications 

Do not use Optune Lua® in patients with an electrical implant. Use of Optune Lua together with electrical implants has not been tested and may lead to malfunctioning of the implanted device. 

 

Do not use Optune Lua in patients known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions, such as a fall in blood pressure and breathing difficulty.

Warnings and Precautions 

Optune Lua can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure® (the device manufacturer). 

 

Do not prescribe Optune Lua for patients who are pregnant, whom you think might be pregnant, or who are trying to get pregnant, as the safety and effectiveness of Optune Lua in these populations have not been established. 

 

The most common (≥10%) adverse events involving Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel were dermatitis, musculoskeletal pain, fatigue, anemia, dyspnea, nausea, cough, diarrhea, anorexia, pruritus, leukopenia, pneumonia, respiratory tract infection, localized edema, rash, pain, constipation, skin ulcers, and hypokalemia. 

 

Other potential adverse effects associated with the use of Optune Lua include treatment related skin toxicity, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at the site where the arrays make contact with the skin, local warmth and tingling sensation beneath the arrays, medical device site reaction, muscle twitching, and skin breakdown or skin ulcer. 

 

If the patient has an underlying serious skin condition on the chest, evaluate whether this may prevent or temporarily interfere with Optune Lua treatment.

 

Indication For Use

Optune Lua is intended as a treatment concurrent with PD-1/PD-L1 inhibitors or docetaxel for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen. 

 


Please see full Instructions For Use (IFU) and Patient Information and Operation Manual (PIOM) for Optune Lua®.

Important Safety Information 

Contraindications 

Do not use Optune Lua® in patients with an electrical implant. Use of Optune Lua together with electrical implants has not been tested and may lead to malfunctioning of the implanted device. 

 

Do not use Optune Lua in patients known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions, such as a fall in blood pressure and breathing difficulty.

Warnings and Precautions 

Optune Lua can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure® (the device manufacturer). 

 

Do not prescribe Optune Lua for patients who are pregnant, whom you think might be pregnant, or who are trying to get pregnant, as the safety and effectiveness of Optune Lua in these populations have not been established. 

 

The most common (≥10%) adverse events involving Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel were dermatitis, musculoskeletal pain, fatigue, anemia, dyspnea, nausea, cough, diarrhea, anorexia, pruritus, leukopenia, pneumonia, respiratory tract infection, localized edema, rash, pain, constipation, skin ulcers, and hypokalemia. 

 

Other potential adverse effects associated with the use of Optune Lua include treatment related skin toxicity, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at the site where the arrays make contact with the skin, local warmth and tingling sensation beneath the arrays, medical device site reaction, muscle twitching, and skin breakdown or skin ulcer. 

 

If the patient has an underlying serious skin condition on the chest, evaluate whether this may prevent or temporarily interfere with Optune Lua treatment.

 

Indication For Use

Optune Lua is intended as a treatment concurrent with PD-1/PD-L1 inhibitors or docetaxel for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen. 

 


Please see full Instructions For Use (IFU) and Patient Information and Operation Manual (PIOM) for Optune Lua®.

Novocure Websites

This website is intended for US healthcare professionals seeking information on Optune Lua.

 

 

 

 

External links

OptuneGioHCP.com
OptuneLuaHCP.com/MPM
Novocuretrials.com

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US-OPL-00070 v1.0 November 2024