Cancer cells divide and multiply rapidly within the lung cancer tumor. These cancer cells carry different types of electrically charged elements that play a role during the cell division process. Other healthy cells in the thorax multiply at a much slower rate, if at all.
TTFields Mechanism of Action
The NovoTTF-200T device in this study delivers low intensity, wave-like electric fields to the location of the tumor. These fields are known as Tumor Treating Fields (TTFields).
Preclinical studies showed that due to the shape and size of cancer cells when they are multiplying, TTFields cause electrically-charged cellular components of these cells to change their location within the dividing cell, disrupting their normal function and may ultimately lead to cell death.
In addition, cancer cells also contain miniature building blocks that act as tiny motors in moving essential parts of the cells from place-to-place. TTFields interfere with the normal orientation of these tiny motors since they are also electrically charged. As a result, the cancer cell division is slowed, or even stopped, inhibiting tumor growth.
TTFIELDS ARE NOT APPROVED FOR THE TREATMENT OF ADVANCED OR METASTATIC INTRATHORACIC NON-SMALL CELL LUNG CANCER IN THE UNITED STATES. THE SAFETY AND EFFICACY OF TTFIELDS FOR THIS INDICATION HAS NOT BEEN ESTABLISHED.
Past Clinical Experience
To date, the sponsor has investigated a number of similar devices developed to deliver TTFields to different tumors. The main difference between the previously studied devices and NovoTTF-200T is the frequency of TTFields provided by each device. The frequency is adjusted by the manufacturer of the devices in order to optimize the treatment for each treated cancer, based on data from laboratory experiments.
NovoTTF-100L, a previous model of the NovoTTF-200T device, has been evaluated in a pilot study of 42 patients with inoperable non-small cell lung cancer patients who received TTFields in combination with standard chemotherapy to evaluate the safety of TTFields in this indication.
A similar device, the NovoTTF-200A (also called Optune®), delivers TTFields to the brain and is approved by the FDA for the treatment of adults with recurrent and newly diagnosed glioblastoma, a type of aggressive primary brain tumor. Optune has a CE Mark in Europe for the treatment of glioblastoma and is also now approved in Japan.
Based on the science behind TTFields and the clinical results to date, NovoTTF-200T is not expected to have systemic side effects in patients suffering from advanced or metastatic intrathoracic non-small cell lung cancer. In previous studies performed with Optune®, the device investigated in glioblastoma, a high percentage of patients have experienced local skin irritation beneath the transducer arrays, which was mild to moderate in severity in the vast majority of cases.
In the aforementioned study for non-small cell lung cancer, there were no serious systemic side effects attributed by the study doctors to TTFields. The only side effect which was related to the device was mild to moderate skin irritation under the arrays placed on the skin.
The information provided in this website is partial, and you should consult with your treating physician concerning the complete safety profile of TTFields.