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

• ClinicalTrials.gov Identifier: NCT04732520
• Recruitment Status: Active, not recruiting
• First Posted: February 1, 2021
• Last Update Posted: January 9, 2023
• Sponsor: Galvanize Therapeutics, Inc.
• Information provided by (Responsible Party): Galvanize Therapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Cancer	Device: Pulsed electric field treatment using the Aliya System	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Galvanize Therapeutics Early Stage, Non-Small Cell Lung Cancer, Treat and Resect Study
• Actual Study Start Date: March 31, 2021
• Estimated Primary Completion Date: January 31, 2023
• Estimated Study Completion Date: January 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Device and Procedure related serious adverse event rate [ Time Frame: 30 days ]
   The rate of system-related and procedure-related serous adverse events (SAEs)

Secondary Outcome Measures :

1. Technical Success rate [ Time Frame: Acute procedure ]
   The frequency with which the clinician can access the index tumor and delivery energy

Eligibility Criteria

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

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

Contacts and Locations

Locations

Hong Kong

Prince of Wales Hospital

Sha Tin, Hong Kong

Netherlands

Radboud University Medical Center

Nijmegen, Netherlands, 6500HB

Spain

Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz

Madrid, Spain, 28040

Hospital Universitario de Salamanca

Salamanca, Spain, 37007

Sponsors and Collaborators

Galvanize Therapeutics, Inc.

More Information

• Responsible Party: Galvanize Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04732520
• Other Study ID Numbers: CSP-00009
• First Posted: February 1, 2021
• Last Update Posted: January 9, 2023
• Last Verified: January 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms