Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC
Reason given: Strategic
Key facts
- Where
- Philadelphia and Rochester, United StatesSee the 3 sites
- Phase
- Phase 4
Where in United States
- Temple UniversityPhiladelphia, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- Mayo Clinic - RochesterRochester, United StatesNo longer taking part
Trial details
- Who runs it
- Galvanize Therapeutics, Inc.
- Trial code
- NCT05583188
- Record updated
- 19 July 2024
- Original description
A prospective, single-arm, non-randomized, multi-center, open-label study following patients with resectable stage IIB to IIIA non-small cell lung cancer after Pulsed Electric Fields (PEF) ablation who may be candidates for standard of care neoadjuvant use of checkpoint inhibitor (nivolumab) treatment plus platinum doublet chemotherapy.Read full original descriptionShow less
Neoadjuvant Soft Tissue Ablation Utilizing Aliya™ Pulsed Electric Fields With Systemic Therapy in Early-Stage Resectable Non-Small Cell Lung Cancer (NSCLC)
A prospective, single-arm, non-randomized, multi-center, open-label study following patients with resectable stage IIB to IIIA non-small cell lung cancer after Pulsed Electric Fields (PEF) ablation who may be candidates for standard of care neoadjuvant use of checkpoint inhibitor (nivolumab) treatment plus platinum doublet chemotherapy.
Inclusion: 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: 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 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; 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 requires or is likely to require a pneumonectomy.