What stage is the LUNAR trial?
The LUNAR trial with the NOVOTTF-100L System for patients with non-small cell lung cancer (NSCLC) is a pivotal trial that builds on experience from comprehensive preclinical experiments and clinical studies. Because the NovoTTF-100L System is a medical 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 III trial
How can I participate in the LUNAR trial
Please contact an investigator at the trial center closest to you. You may also contact Novocure, the trial sponsor, if you need assistance reaching a trial center.
What are the expected side effects of TTFields?
The use of the NovoTTF-100L System is not expected to have systemic side effects, based on our clinical data to date. Patients have experienced skin irritation beneath the transducer arrays. For more information, see Science of TTFields.
When TTFields are delivered, the transducer arrays may cause mild warming and tingling of the skin underneath them.
Please consult with a study physician at one of the centers participating in the trial for additional information about potential side effects from using the NovoTTF-100L System and the other treatments in the LUNAR clinical trial.
Do I need to carry the device all the time?
The system and the portable battery weigh about 3 kilograms or 6 pounds, 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. For more information on lifestyle related questions, please see Living with TTFields.
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 electrical 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?
You can use the device while maintaining most of your daily routines. The transducer arrays will be concealed 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.
How long do I need to wear the device in the LUNAR 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 lung cancer in the chest or liver 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 about the LUNAR trial, see The LUNAR trial or contact one of the participating centers.
Do patients pay to participate in the LUNAR trial
No. The trial sponsor will provide the NovoTTF-100L System and all supporting accessories free of charge. See the LUNAR trial for more information.