Clinical Trials

Inclusion Criteria:

• ≥ 18 years of age.
• Radiographic findings consistent with a lesion with high pre-procedure probability of malignancy as determined by the investigator to be NSCLC 8th Ed. stage IIB- IIIA cancer or biopsy-confirmed NSCLC 8th Ed. stage IIB-IIIA and lesion size ≤ 5 cm in greatest dimension.
• Lesion is targetable for biopsy and PEF delivery per investigator opinion.
• Patient deemed able to complete neoadjuvant therapy according to their EGFR/ALK mutation status and specific histology (if clinically appropriate) and per the manufacturer’s systemic therapy labeling.
• Patient has been deemed a potential candidate for definitive lung tissue resection by a qualified study investigator.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
• Patient is able to adhere to protocol requirements 8. Patient is able to tolerate general anesthesia.
• Patient is cleared to undergo paralytic anesthesia.
• Patient has provided informed consent.

Exclusion Criteria:

• Presence of advanced, inoperable, or metastatic disease.
• Radiographically suspicious findings for stage IIIA patients indicating a single mediastinal lymph node > 3 cm or multiple mediastinal lymph nodes and, therefore, potentially inoperable.
• Patient has recurrent NSCLC or has previously been treated for NSCLC.
• Patient has received chemotherapy or any other cancer therapy in 2 years prior to PEF ablation.
• Prior treatment with any drug that targets T cell co-regulatory pathways (such as checkpoint inhibitors) in 2 years prior to PEF ablation.
• Patient has implanted lung devices or electronic devices.
• Patient has a serious medical condition that, in the investigator’s opinion, could compromise patient safety or confound the interpretation of the patient’s response.
• Patient requires or is likely to require a pneumonectomy.
• 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 immune-modifying or 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 including known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be performed at sites where mandated locally.
• Patient has any history of organ transplant that requires use of immunosuppressives.
• Patient has clinical signs or symptoms of active tuberculosis infection.
• Patient has history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease.
• 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 documented evidence of acute hepatitis or has an active or uncontrolled infection.
• Patient has undergone major surgery within 30 days prior to study enrollment or has planned for other major surgery to be performed while enrolled in the clinical trial.
• Patient is unable or unwilling to complete all required screening and/or follow-up assessments.
• Patient is currently enrolled in another interventional clinical trial or is receiving treatment with an investigational medication or medical device that conflicts with the study protocol.
• Patient is pregnant or nursing.
• Patient for whom the investigator considers that the PEF ablation is not in the patient’s best interest.
• 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 involuntarily incarcerated or compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.

Eligibility last updated 9/6/22. Questions regarding updates should be directed to the study team contact.