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

Non Small Cell Lung Cancer Clinical Trial

— INCITE ES  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04732520
• Other study ID #: CSP-00009
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: January 2024

Study information

• Verified date: January 2023
• Source: Galvanize Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: January 2024
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Device:
• Pulsed electric field treatment using the Aliya System
pulsed electric field treatment of a single NSCLC tumor

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Sha Tin
Netherlands	Radboud University Medical Center	Nijmegen
Spain	Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario de Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
Galvanize Therapeutics, Inc.

Countries where clinical trial is conducted

Hong Kong,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device and Procedure related serious adverse event rate	The rate of system-related and procedure-related serous adverse events (SAEs)	30 days
Secondary	Technical Success rate	The frequency with which the clinician can access the index tumor and delivery energy	Acute procedure