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

PHASE4TerminatedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

February 1, 2023

Primary Completion Date

February 8, 2024

Study Completion Date

March 18, 2024

Conditions
NSCLC
Interventions
DEVICE

Aliya Pulsed Electric Fields (PEF) ablation

Patients will undergo PEF ablation

DRUG

Nivolumab plus Platinum Doublet Chemotherapy

If EGFR/ALK mutation negative, patients will receive standard of care dosing of three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) post-PEF ablation followed by resection.

DRUG

Standard of care neoadjuvant therapy

Patients not eligible for neoadjuvant nivolumab plus chemotherapy will receive standard of care systemic therapy post-PEF ablation followed by resection.

OTHER

Surgical Resection

Patients not eligible for systemic therapy will receive definitive surgery without neoadjuvant therapy as per institutional standard of care post-PEF ablation.

Trial Locations (3)

19104

University of Pennsylvania, Philadelphia

19122

Temple University, Philadelphia

55905

Mayo Clinic Rochester, Rochester

Sponsors
All Listed Sponsors
lead

Galvanize Therapeutics, Inc.

INDUSTRY

NCT05583188 - Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC | Biotech Hunter | Biotech Hunter