What stage is the COMET trial?
The NovoTTF-100M trial for patients with brain metastasis from non-small cell lung cancer is a Pilot trial that builds on experience from comprehensive preclinical experiments and clinical studies not directly done for the medical condition under investigation. Because the NovoTTF-100A System is a device and not a drug, it does not follow the traditional Phase I, Phase II, Phase III process that an investigational new drug would follow. This Pivotal Trial is similar in structure and purpose to a drug Phase II trial.
How can I take part in the COMET trial?
Do patients pay to participate in the COMET trial?
No. The trial sponsor will provide the NovoTTF-100M System and all supporting accessories free of charge. See the COMET trial for more information.
What are the expected side effects of TTFields?
The use of the NovoTTF-100M System is not expected to have systemic side effects, based on our clinical data to date for various indications. Patients have experienced skin irritation beneath the transducer arrays. For more information, see scientific and clinical experience.
When TTFields are delivered, the transducer arrays may cause mild warming and tingling of the scalp.
Please consult with a study physician at one of the centers participating in the trial centers for additional information about potential side effects from using the NovoTTF-100M and the other treatments in the COMET clinical trial.
Do I need to carry the device all the time?
The system and the portable battery weigh about 3 kilograms altogether and can be carried in a dedicated shoulder bag or backpack when walking around. Patients may not necessarily be physically carrying the system most of the time, but will rather use it while it is continuously placed in one location (e.g. on a desk, a table or on the floor inside the carrying bag). The system was designed to allow the performance of normal daily routines.
Will the use of TTFields pose any risk to family members or other people?
The use of the device will not interfere with household or standard personal electronic devices. There is no exposure of TTFields to non-users, such as co-workers and family members.
How will the device affect my social life?
The device was designed to allow patients to continue with daily routines. You can wear head covers, such as a loose weave wig or a loose-fitting hat that allows for airflow to conceal the transducer arrays, and you may place the array wires underneath your clothes. The Device Support Specialist (DSS) will offer help and support related to appearance issues if you are using TTFields. For additional information, please see living with TTFields.
If I enroll in the COMET trial, will I receive TTFields for brain metastasis?
You will not automatically receive TTFields. The trial is randomized, with half of patients receiving TTFields and half receiving standard of care without TTFields. Nevertheless, for patients who are initially enrolled in the control arm (and do not initially receive TTFields), there is often another opportunity to receive the experimental device: In the event the disease is progressing in the brain according to the study protocol, and if indicated by your study physician, you will be offered to start receiving TTFields. This option, offered to patients in the control arm whenever possible, involves no randomization process and depends only on the patient’s and physician’s decision.
How long do I need to wear the device in the COMET trial?
Patients wear the device throughout the day and night. Patients may remove the device for short breaks to accommodate personal needs. Treatment on the trial continues until your study doctor diagnoses progression of the brain metastases according to the protocol, or until a serious medical condition requires discontinuation of the treatment. In addition, you may decide to stop the TTFields at any point in time after starting the use of the device. For more information, see the COMET trial, or contact one of the participating centers.