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

• Sponsor: Galvanize Therapeutics, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04732520
• Collaborator: (none)
• Enrollment: 40
• Locations: 4
• Arms: 2
• Anticipated Duration (Months): 28
• Patients Per Site: 10
• Patients Per Site Per Month: 0.4

Study Details

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	N/A

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
• Anticipated 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: Mar 31, 2021
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2023

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 [30 days]

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

Secondary Outcome Measures

1. Technical Success rate [Acute procedure]

   The frequency with which the clinician can access the index tumor and delivery energy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Prince of Wales Hospital	Sha Tin		Hong Kong
2	Radboud University Medical Center	Nijmegen		Netherlands	6500HB
3	Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz	Madrid		Spain	28040
4	Hospital Universitario de Salamanca	Salamanca		Spain	37007

Sponsors and Collaborators

• Galvanize Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galvanize Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04732520
• Other Study ID Numbers: CSP-00009
• First Posted: Feb 1, 2021
• Last Update Posted: Jun 3, 2022
• Last Verified: Jun 1, 2022

• 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
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jun 3, 2022