Clinical trial NCT04732520: Feasibility Study of the Aliya System in the Treatment of Early Stage Non-small Cell Lung Cancer
Official title: The Galvanize Therapeutics Early Stage, Non-Small Cell Lung Cancer, Treat and Resect Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Galvanize Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-01
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Device and Procedure related serious adverse event rate
timeFrame: 30 days
Secondary outcomes:
measure: Technical Success rate
timeFrame: Acute procedure
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Madrid
country: Spain
facility: Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
Study officials:
References: