Aliya™ Pulsed Electric Fields (PEF) for Advanced Cancer

Inclusion Criteria:

• Patient has suspected or confirmed metastatic cancer within the lungs, or stage IVnon-small cell lung cancer (NSCLC) requiring biopsy.

• Patient has radiologically documented suspected, or confirmed tumor(s) that are ≤ 5cm in longest diameter and deemed by the investigator to be suitable per studyprocedural 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 forcurative intent, or the patient has refused surgery.

• Life expectancy ≥ 6 months.

Exclusion Criteria:

• Patient has received any prior cancer therapy for current tumor(s) to be treatedwith PEF.

• Patient is scheduled to receive investigational therapies (including device-basedtherapy) that may interfere with the study endpoints while on this study.

• Patient has clinical evidence of leptomeningeal disease or brain metastases thatrequire 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 hormonereplacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiringsystemic treatment, or conditions not expected to recur in the absence of anexternal trigger are permitted to enroll.

• Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroidreplacement therapy for adrenal or pituitary insufficiency) is not considered a formof systemic treatment and is allowed.

• Patient has received systemic treatment with corticosteroids (> 10 mg dailyprednisone or equivalent) or other immunosuppressive medications within 30 daysprior to study enrollment. Inhaled or topical steroids, and adrenal replacementdoses > 10 mg daily prednisone or equivalent are permitted in the absence of activeautoimmune 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 uncontrolledinfection.

• Patient has undergone major surgery (excluding placement of vascular access) within 28 days prior to study enrollment or has planned major surgeries while enrolled inthe study,

Other protocol defined inclusion/exclusion criteria apply