STELLAR study design1

STELLAR was a phase II, prospective, pivotal, single-arm trial

STELLAR was a phase II, prospective, pivotal, single-arm trial designed to study the safety and efficacy of Optune Lua and pemetrexed + cisplatin/carboplatin first-line in patients with unresectable, locally advanced or metastatic, MPM.

STELLAR was a phase II, prospective, pivotal, single-arm trial

Phase II trials can be used for the basis of approval in rare diseases, like MPM. In the STELLAR trial, all patients received the experimental treatment. This is particularly important in the treatment of MPM, where the standard of care and prognosis have not changed for many years.1-4

Learn more about the Humanitarian Use Device (HUD) classification and Humanitarian Device Exemption (HDE) approval pathway
Study population

80 patients affected by
unresectable and previously
untreated MPM who were
candidates for treatment with
pemetrexed + cisplatin or carboplatin

Primary endpoint

Overall survival (OS)
Secondary endpoints

Overall response rate (per mRECIST criteria), progression-free survival (PFS), and safety

Patient selection and baseline characteristics

Patient selection

  • Major inclusion criteria
    • Unresectable MPM
    • No prior chemotherapy or radiation treatment for MPM
    • ≥18 years old
    • At least a 3-month life expectancy
    • Measurable disease per mRECIST 1.1
  • Major exclusion criteria
    • Brain metastases (unless asymptomatic, pretreated, and not requiring steroids)
    • Prior malignancy requiring anti-tumor treatment or concurrent malignancy
    • Significant comorbidity impacting patient’s ability to receive systemic therapy
    • Any implantable electronic device
    • Inadequate hematological, renal, or hepatic function, coagulopathy or severe acute infection

Patient baseline characteristics1,5

Characteristics Optune Lua and pemetrexed + cisplatin/
 
carboplatin (N=80)
Median age, years (range) 67 (27-78)
Sex, no. (%)  
Female 13 (16%)
Male 67 (84%)
Tumor stage, no. (%)  
Locally advanced 67 (84%)
Metastatic 13 (16%)
Tumor pathology, no. (%)  
Epithelioid 53 (66%)
Sarcomatoid/biphasic 21 (26%)
Unknown 6 (8%)
ECOG performance status, no. (%)  
0 45 (56%)
1 35 (44%)

ECOG, Eastern Cooperative Oncology Group; F/U, follow-up; MPM, malignant pleural mesothelioma; mRECIST, modified Response Evaluation Criteria in Solid Tumors; qd, every day; q3w, every 3 weeks; q6w, every 6 weeks.

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

References: 1. Optune Lua. Instructions for Use for Unresectable Malignant Pleural Mesothelioma. Novocure; 2019. 2. US FDA. Humanitarian Device Exemption (HDE) Program: Draft Guidance for Industry and Food and Drug Administration Staff. June 2018. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/UCM389275.pdf. Accessed August 6, 2019. 3. Hazarika M, White RM, Johnson JR, et al. 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. Novocure Data on File Opt-139.1.

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Indications For Use
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The Optune Lua System is indicated for the treatment of adult patients with unresect…