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

Primary Purpose

Non Small Cell Lung Cancer

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pulsed electric field treatment using the Aliya System
Sponsored by
Galvanize Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Hospital
  • Radboud University Medical Center
  • Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz
  • Hospital Universitario de Salamanca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Device and Procedure related serious adverse event rate
The rate of system-related and procedure-related serous adverse events (SAEs)

Secondary Outcome Measures

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

Full Information

First Posted
January 28, 2021
Last Updated
January 6, 2023
Sponsor
Galvanize Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04732520
Brief Title
Feasibility Study of the Aliya System in the Treatment of Early Stage Non-small Cell Lung Cancer
Acronym
INCITE ES
Official Title
The Galvanize Therapeutics Early Stage, Non-Small Cell Lung Cancer, Treat and Resect Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galvanize Therapeutics, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients declining to participate in the treatment arm may self-select to participate in an observational control arm.
Intervention Type
Device
Intervention Name(s)
Pulsed electric field treatment using the Aliya System
Intervention Description
pulsed electric field treatment of a single NSCLC tumor
Primary Outcome Measure Information:
Title
Device and Procedure related serious adverse event rate
Description
The rate of system-related and procedure-related serous adverse events (SAEs)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Technical Success rate
Description
The frequency with which the clinician can access the index tumor and delivery energy
Time Frame
Acute procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Prince of Wales Hospital
City
Sha Tin
Country
Hong Kong
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6500HB
Country
Netherlands
Facility Name
Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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