Non Small Cell Lung CancerINCITE ESNCT04732520
Feasibility Study of the Aliya System in the Treatment of Early Stage Non-small Cell Lung Cancer
A study testing Pulsed electric field treatment using the Aliya System in people with Non Small Cell Lung Cancer, run by Galvanize Therapeutics, Inc. at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Pulsed electric field treatment using the Aliya System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 31 Mar 2021to 13 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Spain2 sites
Fundacion Instituto de Investigation Sanitaria de la Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario de Salamanca
Salamanca, 37007
About this study
Official title: The Galvanize Therapeutics Early Stage, Non-Small Cell Lung Cancer, Treat and Resect Study
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.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Pulsed electric field treatment using the Aliya System
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electric field treatment using the Aliya SystemDevice
pulsed electric field treatment of a single NSCLC tumor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device and Procedure related serious adverse event rate
The rate of system-related and procedure-related serous adverse events (SAEs)
Measured: 30 days
Secondary outcomes (1)
Technical Success rate
The frequency with which the clinician can access the index tumor and delivery energy
Measured: Acute procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start31 Mar 2021
- Primary completion13 Feb 2023
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galvanize Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732520
- Sponsor's protocol ID
- CSP-00009
- Acronym
- INCITE ES
- Status last verified
- Jul 2024
- First submitted
- 28 Jan 2021
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Galvanize Therapeutics Early Stage, Non-Small Cell Lung Cancer, Treat and Resect Study
- ClinicalTrials.gov ID
- NCT04732520
- Acronym / sponsor ID
- INCITE ES / CSP-00009
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Galvanize Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Pulsed electric field treatment using the Aliya SystemPatients 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. |
| Control | No intervention | –Patients declining to participate in the treatment arm may self-select to participate in an observational control arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed electric field treatment using the Aliya Systempulsed electric field treatment of a single NSCLC tumor | Device | Treatment |
Primary outcome
Device and Procedure related serious adverse event rate
Time frame: 30 days
The rate of system-related and procedure-related serous adverse events (SAEs)
1 secondary outcome
Technical Success rate
Time frame: Acute procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed electric field treatment using the Aliya System in people with Non Small Cell Lung Cancer, run by Galvanize Therapeutics, Inc. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Hong Kong, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device and Procedure related serious adverse event rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.