The LUNAR trial (also known as the “EF-24 trial”) is a pivotal (analogous to a drug Phase III trial), randomized controlled trial, designed to test the efficacy and safety of Tumor Treating Fields (TTFields), generated by a medical device, the NovoTTF-100L System [About TTFields] in combination with PD-1 inhibitors or docetaxel for second line treatment of patients with non-small cell lung cancer (NSCLC). The trial is expected to enroll a total of 512 patients. The trial is now enrolling patients in multiple centers across Europe and will soon be open in US and Canada [LUNAR Centers].
The LUNAR Trial Design
Patients with NSCLC whose disease progressed during or after first line therapy are candidates for this trial. Final eligibility can only be determined by the clinical trial physician in one of the clinical trial centers. All patients enrolled in the trial will receive a standard of care treatment for their lung cancer, either PD-1 inhibitor or docetaxel, 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-100L System in addition to standard of care PD-1 inhibitor or docetaxel.
• The Standard of Care Group (control): standard of care PD-1 inhibitor or docetaxel.
Each patient will have 50% chance of entering each of the two groups as determined by a “randomization process” (similar to a coin flip). Eligible patients can be enrolled in the trial no later than 14 days after their diagnosis of NSCLC progression.
If assigned to the TTFields Group, the patient will receive continuous TTFields treatment using the NovoTTF-100L System. In order to apply the device, the patient needs to wear four Transducer Arrays taped on the chest. Transducer Array placement may require shaving of the chest/back before starting to use the device, and twice a week for 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-100L System can maintain the use of the device alone (with the help of a family member or a care giver if needed) or may 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.
In addition, patient will receive standard of care PD-1 inhibitor or docetaxel according to best medical practice of the trial center.
Standard of Care Group
Patients assigned to the Standard of Care Group will receive standard of care PD-1 inhibitor or docetaxel according to best practice of the treating trial center. Patients might benefit from receiving comprehensive follow up exams every 6 weeks that include some testing not typically included in standard of care at no cost to the patient.
In addition, all study participants contribute to future patients by providing additional information and data used to assess the efficacy of TTFields.
For the complete list of eligibility criteria please go to clinicaltrials.gov or consult with a LUNAR trial physician:
Inclusion Criteria (summary, not complete list)
1. Diagnosed with squamous or non-squamous, unresectable, locally advanced or metastatic NSCLC
2. Diagnosed with first radiological progression while on or after first-line treatment
3. At least 18 years of age
Exclusion Criteria (summary, not complete list)
1. Presence of brain metastasis or leptomeningeal spread of the disease
2. Prior surgery or radiation therapy in the lungs (except for palliation purposes)
3. Being unable to operate the NovoTTF-100L device independently or with the help of a caregiver
4. Pregnant women
5. Significant illnesses not associated with the primary disease
6. Implanted electronic devices (e.g. pacemaker) in the upper torso
Expected total enrollment is 512 patients. The trial is currently enrolling in multiple EU medical centers. Please contact one of them as soon as possible if you would like to participate in the LUNAR trial.
The trial sponsor (Novocure) will pay for reasonable treatment related supplies, including the NovoTTF-100L 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.