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

NCT04732520 | Completed FDA Device

• 1 other identifier: CSP-00009
• Study Type: interventional
• Target: 47
• Locations: 3 countries
• Sites: 4

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Device and Procedure related serious adverse event rate

  The rate of system-related and procedure-related serous adverse events (SAEs)

  30 days

Secondary Outcomes (1)

• Technical Success rate

  Acute procedure

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Pulsed electric field treatment using the Aliya System DEVICE

pulsed electric field treatment of a single NSCLC tumor

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galvanize Therapeutics, Inc.: lead

Study Sites (4)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Radboud University Medical Center

Nijmegen, 6500HB, Netherlands

Location

Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 1, 2021
• Study Start: March 31, 2021
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

ES (2); HK (1); NL (1)