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Trial Advances Test of Electronic Cancer Treatment

Inspecting lung X-rays

(National Heart, Lung, and Blood Institute, NIH)

22 Nov. 2021. A clinical trial completed enrollment of lung cancer patients testing a device sending an electric field into their tumors to disrupt cancer cell proliferation. The study is testing a tumor treating fields or TTF system developed by Novocure, a medical device company based in St. Helier, Jersey in the Channel Islands, and sponsor of the trial.

Novocure’s technology sends low-intensity electrical signals into solid tumors to alter the chemistry of proteins in cancer cells. Cell proteins, including tubulin and septin that create the fiber skeletons of cells, are polarized taking positive and negative charges. The spread of solid tumor cancers, says Novocure, requires these proteins to produce the spindles and rings supporting new tumor cells, enabling their proliferation. The company says an electric field disrupts the polarity of these proteins, preventing them from functioning, and interrupting the division of tumor cells. However, healthy cells are not affected.

TTF devices, says Novocure, are small, battery-powered, and can be worn continuously during daily life. For lung cancer patients, four TTF transducer arrays are taped to the chest, and wired to a controller. The controller weighs three kilograms or about six pounds and is carried in a shoulder bag or backpack. The company says the devices are easy to use, and applied in an outpatient setting, but also worn at home, with support specialists available to help.

Novocure was founded in 2000 by Yoram Palti, professor of physiology and biophysics, now professor emeritus, at Technion – Israel Institute of Technology, whose research led to the TTF technology. TTF devices are already authorized by Food and Drug Administration to treat recurring and newly diagnosed glioblastoma, a brain tumor, and mesothelioma, a form of lung cancer, as a supplement to other therapies.

Patients with metastatic non-small cell lung cancer

The late-stage clinical trial is testing a TTF device among patients with metastatic non-small cell lung cancer, the most common form of the disease, accounting for 80 to 85 percent of cases. American Cancer Society expects nearly 236,000 new cases of lung cancer this year in the U.S. leading to some 132,000 deaths. The company says its study team completed enrollment of 276 participants with metastatic non-small cell lung cancer who have not responded to chemotherapy.

The participants at 123 sites in the U.S., Europe, and China are randomly assigned to receive the chemotherapy drug docetaxel or immune checkpoint inhibitor therapy, along with wearing a TTF device on the chest, or standard care therapy of docetaxel or immune checkpoint inhibitors alone. The study team is looking primarily for overall survival time of patients with the TTF device over four years, compared to those taking docetaxel or immune checkpoint inhibitors alone. In addition, the team is measuring progression-free survival time, adherence to TTF therapy, quality of life indicators, and adverse effects.

Novocure plans to report initial findings from the trial by the end of 2022. William Doyle, Novocure’s chairman, says in a company statement that the study “is our first of several late-stage clinical trials expected to deliver final data over the next two years.” Doyle adds that the trial “will provide the first randomized dataset to evaluate increased survival when tumor treating fields is used together with immunotherapy, versus immunotherapy alone.”

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