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LUNAR-4: Pilot, Single Arm, Open-Label, Multinational Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for the Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a PD-1/PD-L1 Inhibitor and Platinum-Based Chemotherapy

The purpose of the study is to test the effectiveness and safety of TTFields therapy, delivered using the NovoTTF-200T device, concomitant with pembrolizumab in subjects with metastatic NSCLC previously treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.

开始日期2024-10-14

申办/合作机构

NovoCure GmbH

NCT06556563 / Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant With Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant With Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58).

This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).

开始日期2024-10-01

申办/合作机构

NovoCure GmbH

[+1]

NL-OMON57019 / SuspendedN/A

LUNAR-4: Pilot, Single Arm, Open-Label, Multinational Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant with Pembrolizumab for the Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC) Previously Treated with a PD-1/PD-L1 Inhibitor and Platinum-Based Chemotherapy - LUNAR-4

开始日期2024-09-10

申办/合作机构

NovoCure GmbH

100 项与 NovoCure GmbH 相关的临床结果

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0 项与 NovoCure GmbH 相关的专利（医药）

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81

项与 NovoCure GmbH 相关的文献（医药）

2024-04-01·Journal of Neuro-Oncology

Virtual multi-institutional tumor board: a strategy for personalized diagnoses and management of rare CNS tumors

Article

作者: Widemann, Brigitte C ; Burton, Eric C ; Butman, John A ; Komlodi-Pasztor, Edina ; Boris, Lisa ; Avgeropoulos, Nicholas G ; Gilbert, Mark R ; Dunbar, Erin M ; Soldatos, Ariane ; Zaghloul, Kareem ; Forsyth, Peter ; Lukas, Rimas V ; Ozer, Byram H ; Chittiboina, Prashant ; Mandel, Jacob ; Dixit, Karan S ; Tsien, Christina I ; Rogers, James L ; Kim, Yeonju ; Snyder, James ; Smith-Cohn, Matthew A ; Ranjan, Surabhi ; Penas-Prado, Marta ; Salacz, Michael E ; Chaudhry, Huma ; Raygada, Margarita ; Aboud, Orwa ; Acquaye-Mallory, Alvina A ; Lee, Eudocia Q ; Heiss, John D ; Wall, Thomas ; Smirniotopoulos, James G ; Cachia, David M ; Drappatz, Jan ; Armstrong, Terri S ; Quezado, Martha M ; Theeler, Brett J ; Aldape, Kenneth ; Camphausen, Kevin A

AbstractPurposeMultidisciplinary tumor boards (MTBs) integrate clinical, molecular, and radiological information and facilitate coordination of neuro-oncology care. During the COVID-19 pandemic, our MTB transitioned to a virtual and multi-institutional format. We hypothesized that this expansion would allow expert review of challenging neuro-oncology cases and contribute to the care of patients with limited access to specialized centers.MethodsWe retrospectively reviewed records from virtual MTBs held between 04/2020–03/2021. Data collected included measures of potential clinical impact, including referrals to observational or therapeutic studies, referrals for specialized neuropathology analysis, and whether molecular findings led to a change in diagnosis and/or guided management suggestions.ResultsDuring 25 meetings, 32 presenters discussed 44 cases. Approximately half (n = 20; 48%) involved a rare central nervous system (CNS) tumor. In 21% (n = 9) the diagnosis was changed or refined based on molecular profiling obtained at the NIH and in 36% (n = 15) molecular findings guided management. Clinical trial suggestions were offered to 31% (n = 13), enrollment in the observational NCI Natural History Study to 21% (n = 9), neuropathology review and molecular testing at the NIH to 17% (n = 7), and all received management suggestions.ConclusionVirtual multi-institutional MTBs enable remote expert review of CNS tumors. We propose them as a strategy to facilitate expert opinions from specialized centers, especially for rare CNS tumors, helping mitigate geographic barriers to patient care and serving as a pre-screening tool for studies. Advanced molecular testing is key to obtaining a precise diagnosis, discovering potentially actionable targets, and guiding management.

2023-12-08·Neuro-Oncology

Towards more Diversity in Neuro-oncology Leadership—the DivINe Initiative

Letter

作者: von Baumgarten, Louisa ; Grosu, Anca-L ; McLean, Anna ; Albert, Nathalie L ; Hegi, Monika ; Rosahl, Steffen K ; Sevenich, Lisa ; Gempt, Jens ; Tabatabai, Ghazaleh ; Combs, Stephanie E ; Schwarzenberger, Julia ; Abrey, Lauren E ; Stammberger, Anja ; Renovanz, Mirjam ; Nowosielski, Martha ; Leidgens, Verena ; Urbanic Purkart, Tadeja ; Kurz, Sylvia C

2023-11-10·Neuro-Oncology

QOL-19. TUMOR TREATING FIELDS (TTFIELDS) THERAPY IN GLIOBLASTOMA (GBM): RELATIONSHIP BETWEEN PATIENT EXPERIENCE, GLOBAL REGION, AND AGE

作者: Batzianouli, Eleni ; Shockley, Shermona ; Johnson, Heather ; Gage Gwyn, P ; Abdullah, Huda Ismail ; Adams, Renae

AbstractBACKGROUNDTTFields therapy is a noninvasive, locoregional anticancer treatment approved for newly diagnosed and recurrent GBM based on efficacy and safety results in 2 global, randomized pivotal studies, supported by real-world evidence.METHODSIn 2022, 2 questionnaires (mail or online) surveyed the real-world experiences of patients with GBM receiving TTFields therapy (NovoTTF-200A; Novocure®, GmBH) and their caregivers in Germany, Austria, and Switzerland (DACH), and the USA.RESULTS545/1197 surveys were returned in DACH (46%); 1332/5031 in the USA (26%). Most respondents indicated satisfaction/high satisfaction with TTFields (in patients starting therapy, 82% [DACH] and 58% [USA]; in patients with >6 months use, 67% [DACH] and 72% [USA]). The following data pertain to patients with >6 months of TTFields use (n = 114 DACH; n = 375 USA). 63% in DACH reported that daily life was changed “much”/“very much”, and 35% “hardly at all”; in the USA, 17% indicated they were able to live as they did before therapy, 61% had to make adjustments but had returned to a normal routine, and 23% said therapy had markedly impacted daily life. 74% (DACH) and 73% (USA) would recommend to other patients. Common reasons for low satisfaction included skin irritation and device handling. To assess any impact of age, responses from patients aged ≥70 years ( >6 months use) from the USA (n = 82 [22%]) were analyzed (there were not enough elderly patients with >6 months use in DACH [n = 8] to analyze). As with the overall population, elderly patients in the USA reported they were satisfied/very satisfied (67%). 66% of elderly patients (USA) were very likely to recommend TTFields to someone else.CONCLUSIONSSurveys of patient/caregivers in DACH and the USA who used TTFields for GBM identified a high degree of satisfaction, including elderly patients. Most respondents would recommend TTFields to others.

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