The KEYNOTE B36 study is a pilot, single arm, open-label study designed to evaluate the safety and effectiveness of Tumor Treating Fields (TTFields), generated by the medical device NovoTTF-200T [About TTFields]. Study patients use the device concomitant with pembrolizumab for first line treatment of advanced or metastatic intrathoracic non-small cell lung cancer (NSCLC). The study is expected to enroll 66 patients. The study will soon be enrolling patients in multiple medical centers across North America [KEYNOTE B36 Centers].

The KEYNOTE B36 Study Design

The study is for newly-diagnosed advanced or metastatic intrathoracic NSCLC.

Final eligibility can only be determined by the clinical study physician in one of the clinical study centers.

All patients enrolled in the study will receive TTFields treatment, delivered for at least 18 hours a day on average using NovoTTF-200T together with pembrolizumab, a standard immunotherapy agent, which is delivered intravenously.

Using the Device

To receive treatment, the patient needs to wear four adhesive patches called arrays on their chest which deliver the TTFields non-invasively to the tumor location. 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 arrays are replaced and re-applied on a regular basis for as long as the patient is receiving the treatment.

The use of NovoTTF-200T 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].

Once trained, patients using NovoTTF-200T can setup and use the device themselves (with the help of a family member or a caregiver if needed), or may receive support from their DSS.

The device is designed to be 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.

Eligibility
For the complete list of eligibility criteria please go to clinicaltrials.gov or consult with a KEYNOTE B36 study physician:

Inclusion Criteria (summary, not complete list)

  1. Diagnosed with stage III or metastatic intrathoracic NSCLC
  2. Has a PD-L1 positive (TPS≥1%) tumor
  3. Has not received prior treatments for NSCLC (palliative treatment is allowed)
  4. At least 22 years of age

Exclusion Criteria (summary, not complete list)

  1. Has an extrathoracic metastasis (ie M component is M1b or M1c)
  2. Has an EGFR sensitizing mutation and/or ALK translocation
  3. Can be treated with curative intent with either surgical resection and/or chemoradiation
  4. Has received prior systemic anti-cancer therapy or prior radiotherapy for NSCLC
  5. Being unable to operate the NovoTTF-200T device independently or with the help of a caregiver
  6. Pregnant women
  7. Significant illnesses not associated with the primary disease
  8. Implanted electronic devices (e.g. pacemaker) in the upper torso

Enrollment
Expected total enrollment is 66 patients. The study will be enrolling patients in multiple medical centers in North America. Please contact one of them as soon as possible if you would like to participate in the KEYNOTE B36 study.

Study Costs
There will be no cost to participate in this study.  The study sponsor (Novocure) will pay for reasonable treatment related supplies, including the NovoTTF-200T device and accessories. Patients and their insurance will be responsible for medical treatments received in the normal course of patient care. The study sponsor will also reimburse patients for reasonable travel costs directly related to the study’s procedures. Such reimbursements are done according to the policy of the study center at which the patient is being treated. Prior to enrolling in the study, please consult with the clinical study team at the center about the local reimbursement policy and your rights.