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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor: Galvanize Therapeutics, Inc.
Study ID: NCT05583188
Phase: PHASE4
Status: Terminated

Conditions

NSCLC

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Aliya Pulsed Electric Fields (PEF) ablation — DEVICE
Patients will undergo PEF ablation
Nivolumab plus Platinum Doublet Chemotherapy — DRUG
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.
Standard of care neoadjuvant therapy — DRUG
Patients not eligible for neoadjuvant nivolumab plus chemotherapy will receive standard of care systemic therapy post-PEF ablation followed by resection.
Surgical Resection — OTHER
Patients not eligible for systemic therapy will receive definitive surgery without neoadjuvant therapy as per institutional standard of care post-PEF ablation.

Study Details

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.