The METIS trial (also known as the “EF-25 trial”) is a pivotal (analogous to drug Phase III), randomized, controlled trial, designed to test the efficacy and safety of Tumor Treating Fields (TTFields), generated by a medical device, the NovoTTF-100M System [About TTFields] in patients with 1-10 newly diagnosed brain metastases from non-small cell lung cancer (NSCLC). TTFields are administered to patients concomitantly with the best standard of care treatments which would normally be used to treat lung cancer. The trial is expected to enroll a total of 270 patients. The trial is now enrolling patients in multiple centers in the US and will soon be open in Canada and across Europe [METIS Centers].
The METIS Trial Design
Patients with 1 inoperable or 2-10 newly diagnosed brain metastases from NSCLC are candidates for this 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 stereotactic radiosurgery (SRS) for their brain metastasis in addition to the best standard of care treatments for their lung cancer and brain metastases (including chemotherapy), similar to patients who are not participating in the trial. All patients will be randomly assigned to one of two groups:
- The TTFields Group: TTFields using the NovoTTF-100M System in addition to best standard of care
- The Standard of Care Group (control): Best standard of care without TTFields.
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 TTFields after their disease in the brain progresses twice according to the study protocol [Q&A]. Eligible patients can be enrolled in the trial no later than 21 days after their diagnosis of brain metastases.
If assigned to the TTFields Group, the patient will receive continuous TTFields treatment using the NovoTTF-100M System. In order to apply the device, the patient needs to wear four Transducer Arrays taped on the scalp [About TTFields]. 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 [Living with TTFields]. 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 Group will receive standard dosing of approved medications, the treatments which are the most appropriate for any medical condition (including lung cancer), according to best practice of the treating trial physician. Patients might benefit from receiving comprehensive follow up exams every 8 weeks 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 after their disease in the brain progresses twice 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)
- Newly diagnosed with 1 inoperable brain metastases, or 2-10 previously untreated brain metastases from non-small cell lung cancer (NSCLC)
- All brain metastases are amenable to stereotactic radiosurgery (SRS)
- At least 18 years of age
Exclusion Criteria (summary, not complete list)
- Prior treatment for brain metastasis
- 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
- Implanted electronic devices in the brain
Expected total enrollment is 270 patients. The trial is currently enrolling in multiple US medical centers. Please contact one of them as soon as possible if you would like to participate in the METIS trial.
The trial sponsor (Novocure) will pay for reasonable treatment related supplies, including the NovoTTF-100M system and accessories. Patients and their insurance will be responsible for medical treatments received in the normal course of patient care. The trial sponsor will also reimburse patients for some travel costs related to the trial’s procedures. Such reimbursement can be done only according to the policy of the trial center at which the patient is being treated. Please consult with the clinical trial team at the center prior to enrolling in the trial about the local reimbursement policy and your rights.