Feasibility Study of the Aliya System in the Treatment of Early Stage Non-small Cell Lung Cancer (INCITE ES)

The Galvanize Therapeutics Early Stage, Non-Small Cell Lung Cancer, Treat and Resect Study

A prospective, two-arm, non-randomized, concurrently controlled, multi-center, open-label, treat and resect study following patients to 1 year. The study is designed to evaluate the safety and feasibility of the Aliya System for the ablation of solid tumors using pulsed electric field (PEF) energy delivery. The study is intended for adult patients with suspected or confirmed NSCLC 8th ed. Stage IA2, IA3 or IB (>1 to ≤4 cm solitary lesion) who are surgical candidates and have not received treatment for the index tumor in the last two years.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Device: Pulsed electric field treatment using the Aliya System

Detailed Description

This study is to evaluate the safety and initial feasibility of Pulsed Electric Field (PEF) treatment of NSCLC tumors prior to surgical resection.

Treatment may be delivered via either an endoluminal (bronchoscopic) or percutaneous approach at the discretion of the clinical investigator utilizing two available device configurations:

• Endoluminal: Galvanize Aliya System with commercially available TBNA Needle (e.g., PeriView FLEX) and RF probe electrode
• Percutaneous: Galvanize Aliya System with compatible commercially available RF needle and RF probe electrode

The study will enroll and treat up to 30 adult patients with early stage NSCLC at up to 5 clinical sites. Patients meeting all eligibility criteria who elect not to undergo the PEF treatment will be offered the opportunity to participate in a concurrent control arm. Up to 10 patients will be included in the control group. A total of up to 40 patients will be included in the study.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Sha Tin, Hong Kong
    • Prince of Wales Hospital
• Netherlands
  • Nijmegen, Netherlands, 6500HB
    • Radboud University Medical Center
• Spain
  • Madrid, Spain, 28040
    • Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz
  • Salamanca, Spain, 37007
    • Hospital Universitario De Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Presence of solitary NSCLC nodule 8th ed. stage IA2, IA3 or IB
• Nodule measuring > 1 cm and ≤4 cm diameter by CT size estimate (e.g. T1b, T1c, T2a), with a minimum 1 cm solid component
• High pre-procedure probability of malignancy as determined by the investigator
• Patient has been evaluated by a thoracic surgeon and deemed a candidate for definitive lung tissue resection
• Patient is, in the opinion of the principal investigator, able to adhere to and undergo bronchoscopy, surgical procedure and post-treatment care

Exclusion Criteria:

• Additional pulmonary nodules requiring intervention
• Patient is receiving concurrent cancer treatment (e.g. external beam radiation therapy, brachytherapy, chemotherapy, targeted therapy, immunotherapy, other focal therapy) or has received treatment for the index tumor in the last two years
• Patient has implanted lung devices or electronic devices
• Patient has N1 disease
• Patient is immune compromised or receiving immune modulating medication
• Recurrent NSCLC within 2 years of initial definitive treatment
• Previous checkpoint inhibitor treatment for another cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Patients participating in the treatment group will undergo pulsed electric field (PEF) treatment of a single NSCLC nodule measuring 1 to 4 cm by CT, using the Aliya System. The treatment may be performed endoluminally in conjunction with a diagnostic bronchoscopy, or percutaneously.	Device: Pulsed electric field treatment using the Aliya System; pulsed electric field treatment of a single NSCLC tumor
No Intervention: Control; Patients declining to participate in the treatment arm may self-select to participate in an observational control arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device and Procedure related serious adverse event rate	The rate of system-related and procedure-related serous adverse events (SAEs)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success rate	The frequency with which the clinician can access the index tumor and delivery energy	Acute procedure

Collaborators and Investigators

• Sponsor: Galvanize Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): February 13, 2024

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CSP-00009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes