Inclusion Criteria:

Candidates for this study must meet ALL of the following criteria:

• Patient is 22 years of age or older.
• Patient has suspected or confirmed metastatic cancer within the lungs, or stage IV nonsmall cell lung cancer (NSCLC) requiring biopsy.
• Patient has radiologically documented suspected or confirmed tumor(s) that are ≤ 5 cm in longest diameter and deemed suitable by the investigator per study procedural guidelines for treatment with PEF.
• Patient is deemed eligible to receive 1L SOC therapy for their malignancy.
• In the opinion of the investigator, the patient is not a surgical candidate for curative intent, or the patient has refused surgery.
• Life expectancy ≥ 6 months.
• Patient has provided informed consent.

Exclusion Criteria:

Candidates will be excluded if ANY of the following apply:

• Patient has received any prior cancer therapy for current tumor(s) to be treated with PEF.
• Patient is scheduled to receive investigational therapies (including device-based therapy) that may interfere with the study endpoints while on this study.
• Patient has clinical evidence of leptomeningeal disease or brain metastases that require SOC treatment within 4 weeks post-PEF treatment.
• Patient with active, known, or suspected autoimmune disease:
  • Patient with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;
  • Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• Patient has received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 30 days prior to study enrollment. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
• Patient has any history of primary immunodeficiency.
• Patient has clinical signs or symptoms of active tuberculosis infection.
• Patient has documented evidence of acute hepatitis or has an active or uncontrolled infection.
• Patient has undergone major surgery (excluding placement of vascular access) within 28 days prior to study enrollment or has planned major surgeries while enrolled in the study.
• Patient with ≥ Grade 2 peripheral neuropathy.
• Patient has received any vaccine against infectious diseases (e.g., influenza, COVID-19, varicella, etc.) within 30 days of PEF procedure.
• Patient has electronic implant(s) such as cardiac pacemaker, and the patient is not suitable for PEF treatment in the opinion of the investigator.
• Patient has active alcohol or drug addiction or any other condition that, in the investigator’s opinion, would interfere with their ability to comply with the study requirements or jeopardize the safety of the patient or compliance with the protocol.
• Patient is unable or unwilling to complete all required study activities.
• Patient is pregnant or nursing.
• Patient is involuntarily incarcerated or compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/16/23. Questions regarding updates should be directed to the study team contact.