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

NCT ID: NCT04732520

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2024-02-13

Brief 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.

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pulsed electric field treatment using the Aliya System

Intervention Type: DEVICE

pulsed electric field treatment of a single NSCLC tumor

Control

Patients declining to participate in the treatment arm may self-select to participate in an observational control arm.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pulsed electric field treatment using the Aliya System

pulsed electric field treatment of a single NSCLC tumor

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galvanize Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Prince of Wales Hospital

Shatin, , Hong Kong

Radboud University Medical Center

Nijmegen, , Netherlands

Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Countries

Hong Kong; Netherlands; Spain

Other Identifiers

CSP-00009

Identifier Type: -

Identifier Source: org_study_id