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Study Design

STELLAR was a phase 2, prospective, pivotal, single-arm study¹

STELLAR was a prospective, multicenter, single-arm, phase 2 study designed to study the safety and efficacy of Optune Lua and pemetrexed + cisplatin or carboplatin first line in patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM).

^*CT of the chest and MRI and/or bone scan (if clinically indicated) were performed every 6 weeks until progression with a minimum follow-up of 12 months.

Phase 2 studies can be used for the basis of approval for making applications such as HDE. In the STELLAR study, all patients received the experimental treatment. This had been particularly important in the treatment of MPM, where the standard of care and prognosis had not changed for many years.^1-4

Optune Lua was FDA approved under the Humanitarian Device Exemption (HDE) pathway and is classified as an Humanitarian Use Device (HUD)^1,5

See FDA approval pathway

Patient selection and baseline characteristics¹

^†Patients with unresectable tumors were considered Stage IV at the time the protocol was written. Per a revision of the American Joint Committee on Cancer (AJCC) staging system in 2017, patients with unresectable tumors may be currently classified in either a Stage IIIB or Stage IV prognostic group.⁶

Patient baseline characteristics^1,5

The 2019 STELLAR publication is available through Lancet Oncology

Ceresoli GL, Aerts JG, Dziadziuszko R, et al. Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial. Lancet Oncol. 2019;20(12):1702-1709. doi:10.1016/S1470-2045(19)30532-7

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ECOG, Eastern Cooperative Oncology Group; f/u, follow-up; mRECIST, modified Response Evaluation Criteria in Solid Tumors; qd, every day; q3w, every 3 weeks; q6w, every 6 weeks; TNM, tumor, node, metastasis.

References: 1. Optune Lua. Instructions for Use for Unresectable Malignant Pleural Mesothelioma. Novocure; 2021. 2. US FDA. Humanitarian Device Exemption (HDE) Program: Draft Guidance for Industry and Food and Drug Administration Staff. September 6, 2019. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM389275.pdf. Accessed January 3, 2020. 3. Hazarika M, White RM, Johnson JR, Pazdur R. FDA drug approval summaries: pemetrexed (Alimta^®). The Oncologist. 2004;9(5):482-488. 4. Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003;21(14):2636-2644. 5. Ceresoli GL, Aerts JG, Dziadziuszko R, et al. Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial. Lancet Oncol. 2019;20(12):1702-1709. doi:10.1016/S1470-2045(19)30532-7 6. American Cancer Society. Malignant Mesothelioma Stages. Updated November 16, 2018. Accessed June 17, 2024. https://www.cancer.org/cancer/types/malignant-mesothelioma/detection-diagnosis-staging/staging.html

Important Safety Information

Contraindications

Do not use Optune Lua in patients with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc. Use of Optune Lua together with implanted electronic devices 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. Skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

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

The most common (≥10%) adverse events involving Optune Lua in combination with chemotherapy were anemia, constipation, nausea, asthenia, chest pain, fatigue, medical device site reaction, pruritus, and cough.

Other potential adverse effects associated with the use of Optune Lua include: treatment related skin toxicity, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical device site reaction and skin breakdown/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.

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

Please click here to see Optune Lua Instructions For Use (IFU) for complete information regarding the device's indications, contraindications, warnings, and precautions.

Study Design

STELLAR was a phase 2, prospective, pivotal, single-arm study1

Optune Lua was FDA approved under the Humanitarian Device Exemption (HDE) pathway and is classified as an Humanitarian Use Device (HUD)1,5

Patient selection and baseline characteristics1

Patient baseline characteristics1,5