Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC

Inclusion Criteria

• Patient is 18 years of age or older
• 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
• 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 requires or is likely to require a pneumonectomy
• Patient has received any vaccine against infectious diseases (e.g., influenza, COVID-19, varicella, etc.) within 30 days of PEF procedure 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 Other protocol defined inclusion/exclusion criteria apply