The COMET trial (also known as the “EF-21 trial”) is a Pilot (analogous to drug Phase II), randomized, controlled trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100M system in patients with 1-5 brain metastasis from non-small cell lung cancer. TTFields are administered to patients concomitantly to the best standard of care treatments which would normally be used to treat their lung cancer. The trial is expected to enroll a total of 60 patients. The trial is now enrolling patients in multiple centers in Europe.
The COMET Trial Design
Patients with 1-5 brain metastasis from non-small cell lung cancer who have completed standard optimal treatment for their metastases (stereotactic radiation surgery (SRS), neurosurgery or a combination of the two treatments) are candidates for the clinical trial. Final eligibility can only be determined by the clinical trial physician in one of the clinical trial sites. All patients enrolled in the trial will receive the best standard treatments (including chemotherapy) for their lung cancer and for any other medical condition, similar to patients who are not participating in the trial. All patients will be randomly assigned to one of two groups:
1) the TTFields group: The NovoTTF-100M System combined with the best standard of care
2) the control group: Best standard of care only.
Each patient will have 50% chance of entering each of the two groups as determined by a “randomization process” (similar to a coin flip). Patients enrolled in the standard of care group might still be able to receive the NovoTTF-100M System if their disease in the brain progresses according to the study protocol. Eligible patients can be enrolled in the trial no later than 14 days after completing their local treatment (by SRS/surgery/combination of the two) for their brain metastases.
If assigned to the TTFields Group, the patient will receive continuous TTFields using the NovoTTF-100M System. In order to apply the device, the patient needs to wear four transducer arrays taped on the scalp. Transducer array placement will require shaving of the entire scalp before starting to use the device, and twice a week as long as its use continues.
The use of the device will start in an outpatient setting and will include training on the operation of the equipment by a qualified Novocure Device Support Specialist (DSS). Patients will continue to use the device at home. Patients using the NovoTTF-100M System can maintain the use of the device alone (with the help of a family member or a care giver if needed) or receive support from their DSS.
The system is user-friendly and all technical aspects related to using it are maintained by the DSS. The DSS can also help patients in finding technical solutions to allow each individual to receive TTFields while maintaining his/her normal daily routines.
Standard of Care Group
Patients assigned to the standard of care only group will receive standard dosing of approved medications, the treatments which is the most appropriate for any medical condition (including lung cancer), according to the treating trial physician. Patients might benefit from receiving comprehensive monthly follow up exams that include some testing not typically included in standard of care at no cost to the patient. Patients enrolled in the standard of care group might still be able to receive TTFields if their disease in the brain progresses according to the study protocol.
In addition, all study participants contribute to future patients by providing additional information and data used to assess the efficacy of TTFields.
Inclusion Criteria (Summary, not complete list)
- Diagnosed with 1-5 brain metastases from non-small cell lung cancer (NSCLC)
- All brain metastases were amenable to either surgical resection, stereotactic radiosurgery (SRS) or a combination of both
- At least 18 years of age
- Stable tumor outside of the brain in the last 3 months (unless the disease has not been diagnosed before and did not cause symptoms)
Exclusion Criteria (Summary, not complete list)
- Prior treatment with whole brain radiotherapy treatment (WBRT)
- being unable to operate the NovoTTF-100M device independently or with the help of a caregiver
- Pregnant women
- Significant illnesses not associated with the primary disease
- Pacemaker or other implanted electronic devices
Expected total enrollment is 60 patients. The trial is currently enrolling in several European medical centers. Please contact one of them as soon as possible if you would like to participate in the COMET trial.
The trial sponsor (Novocure) will pay for reasonable treatment related supplies, including the NovoTTF-100M system and accessories. The trial sponsor will also reimburse patients for some travel costs related to trials procedure. Such reimbursement can be done only according to the policy of the trial center the patient is treated at and upon approval by the trial sponsor. Please consult with the clinical trial team at the center prior to enrolling in the trial about the local reimbursement policy and your rights. Patients and their insurance will be responsible for medical treatments received in the normal course of patient care.