NCT04471844: EF-32

Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM

Completed NA Last updated 30 March 2026

What this trial tests

NA trial testing Optune® in Glioblastoma Multiforme in 981 participants. Completed in 19 February 2026.

Timeline

8 December 2020

Primary endpoint
19 February 2026

19 February 2026

Quick facts

Lead sponsor	NovoCure Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	981
Start date	8 December 2020
Primary completion	19 February 2026
Estimated completion	19 February 2026
Sites	133 locations across France, Japan, Belgium, Austria, United Kingdom, Germany, Israel, Canada

Drugs / interventions tested

• Optune®

Conditions studied

• Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →

Sponsor

NovoCure Ltd.

Who can join

18 and older, any sex, with Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glioblastoma Therapy: Past, Present and Future.
   Obrador E, Moreno-Murciano P, Oriol-Caballo M, López-Blanch R, et al · · 2024 · cited 147× · PMID 38473776 · DOI 10.3390/ijms25052529
2. Updates in IDH-Wildtype Glioblastoma.
   Melhem JM, Detsky J, Lim-Fat MJ, Perry JR. · · 2022 · cited 55× · PMID 35641844 · DOI 10.1007/s13311-022-01251-6
3. Tumor-Treating Fields in Glioblastomas: Past, Present, and Future.
   Guo X, Yang X, Wu J, Yang H, et al · · 2022 · cited 39× · PMID 35954334 · DOI 10.3390/cancers14153669
4. Tumor Treating Fields (TTFields) increase the effectiveness of temozolomide and lomustine in glioblastoma cell lines.
   Fishman H, Monin R, Dor-On E, Kinzel A, et al · · 2023 · cited 25× · PMID 37131108 · DOI 10.1007/s11060-023-04308-4
5. Scalp-Sparing Radiation With Concurrent Temozolomide and Tumor Treating Fields (SPARE) for Patients With Newly Diagnosed Glioblastoma.
   Miller R, Song A, Ali A, Niazi M, et al · · 2022 · cited 22× · PMID 35574391 · DOI 10.3389/fonc.2022.896246
6. Recent advances in Tumor Treating Fields (TTFields) therapy for glioblastoma.
   Khagi S, Kotecha R, Gatson NTN, Jeyapalan S, et al · · 2025 · cited 20× · PMID 39401002 · DOI 10.1093/oncolo/oyae227
7. The Routine Application of Tumor-Treating Fields in the Treatment of Glioblastoma WHO° IV.
   Krigers A, Pinggera D, Demetz M, Kornberger LM, et al · · 2022 · cited 15× · PMID 35785334 · DOI 10.3389/fneur.2022.900377
8. Tumor-treating fields (TTFields)-based cocktail therapy: a novel blueprint for glioblastoma treatment.
   Wang M, Zhang C, Wang X, Yu H, et al · · 2021 · cited 15× · PMID 33948346