Lung Neoplasm MalignantAFFINITYNCT05890872
Aliya™ Pulsed Electric Fields (PEF) for Advanced Cancer
A study testing Aliya Pulsed Electric Fields (PEF) in people with Lung Neoplasm Malignant, run by Galvanize Therapeutics, Inc. at 5 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate safety of delivering Aliya PEF in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasm Malignant
- What is being tested?
- Aliya Pulsed Electric Fields (PEF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Sep 2023to 13 Aug 2025
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient has suspected or confirmed metastatic cancer within the lungs, or stage IV non-small cell lung cancer (NSCLC) requiring biopsy.
- Patient has radiologically documented suspected, or confirmed tumor(s) that are ≤ 5 cm in longest diameter and deemed by the investigator to be suitable per study procedural guidelines for treatment with PEF.
- Patient is deemed eligible to receive 1L SOC therapy for their malignancy.
- In the opinion of the investigator, the patient is not a surgical candidate for curative intent, or the patient has refused surgery.
- Life expectancy ≥ 6 months.
Who cannot join
- Patient has received any prior cancer therapy for current tumor(s) to be treated with PEF.
- Patient is scheduled to receive investigational therapies (including device-based therapy) that may interfere with the study endpoints while on this study.
- Patient has clinical evidence of leptomeningeal disease or brain metastases that require SOC treatment within 4 weeks post-PEF treatment.
- Patient with active, known, or suspected autoimmune disease.
- Patient with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
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- Patient has received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 30 days prior to study enrollment. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
- Patient has any history of primary immunodeficiency.
- Patient has clinical signs or symptoms of active tuberculosis infection.
- Patient has documented evidence of acute hepatitis or has an active or uncontrolled infection.
- Patient has undergone major surgery (excluding placement of vascular access) within 28 days prior to study enrollment or has planned major surgeries while enrolled in the study,
- Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Mayo Clinic
Jacksonville, Florida, 32224
Weill Cornell Medicine | New York-Presbyterian
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
FirstHealth of the Carolinas, Inc.
Pinehurst, North Carolina, 28374
Mayo Clinic Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Clinical Study of Aliya™ Pulsed Electric Fields (PEF) Delivered Prior to Standard of Care Treatment for Advanced Cancer
The goal of this clinical trial is to evaluate safety of delivering Aliya PEF in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy.
Read the detailed description
The Aliya Treatment System is designed to deliver therapeutic PEF energy to target tissues, via either a percutaneous or bronchoscopic approach. In order to evaluate the therapeutic potential of PEF delivered via the Aliya Treatment System as an interventional treatment, this clinical trial will evaluate the safety of delivering Aliya PEF in non-surgical advanced stage disease treatment-naïve patients indicated for diagnostic biopsy and first line (1L) standard of care (SOC) therapy. Additionally, this study will examine the safety of adding PEF treatment to the care pathway for patients with metastatic cancer to the lung or stage IV NSCLC and further assess the potential immune modulation and treatment effect of PEF for providing benefit to oncological patients, as outlined below.
- Conditions
- Lung Neoplasm Malignant
- Being tested
- Aliya Pulsed Electric Fields (PEF)
- Keywords
- Lung Neoplasms, Thoracic Neoplasms, Immunologic Factors
- Medical subject headings
- Lung Neoplasms, Thoracic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliya Pulsed Electric Fields (PEF)Device
Percutaneous or Endobronchial PEF
| Study group | Role | What they receive |
|---|---|---|
| Aliya PEF | Experimental | Pulsed electric field treatment using the Aliya System Receives: Device: Aliya Pulsed Electric Fields (PEF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device and Procedure related serious adverse events
The rate of study device-related and/or PEF procedure-related serious adverse events (SAEs)
Measured: 30 days post PEF
Percentage of subjects whose SOC cancer treatment was not cancelled or postponed
The percentage of subjects whose SOC cancer treatment was not cancelled or postponed due to a PEF device- or procedure-related AE
Measured: 1 year Post PEF
Secondary outcomes (4)
Procedural success
The frequency with which physicians can deliver PEF energy to intended targets
Measured: Day of procedure
Anesthesia Type Usage
Anesthesia Type Usage
Measured: During PEF procedure
PEF Target Location
Anatomic lung region treated with PEF
Measured: During PEF procedure
Initiation of first-line (1L) SOC therapy following PEF treatment
Time to initiate first-line (1L) SOC therapy following PEF treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start6 Sep 2023
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Neoplasm MalignantStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galvanize Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Krimsky, MD, Study chair, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890872
- Sponsor's protocol ID
- CSP-00018
- Acronym
- AFFINITY
- Status last verified
- Aug 2025
- First submitted
- 5 May 2023
- Last updated
- 20 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Aliya™ Pulsed Electric Fields (PEF) Delivered Prior to Standard of Care Treatment for Advanced Cancer
- ClinicalTrials.gov ID
- NCT05890872
- Acronym / sponsor ID
- AFFINITY / CSP-00018
- Conditions
- Lung Neoplasm Malignant
- Keywords
- Lung Neoplasms, Thoracic Neoplasms, Immunologic Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Galvanize Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 6 Jun 2023 (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.
The goal of this clinical trial is to evaluate safety of delivering Aliya PEF in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy.
Detailed description
The Aliya Treatment System is designed to deliver therapeutic PEF energy to target tissues, via either a percutaneous or bronchoscopic approach. In order to evaluate the therapeutic potential of PEF delivered via the Aliya Treatment System as an interventional treatment, this clinical trial will evaluate the safety of delivering Aliya PEF in non-surgical advanced stage disease treatment-naïve patients indicated for diagnostic biopsy and first line (1L) standard of care (SOC) therapy. Additionally, this study will examine the safety of adding PEF treatment to the care pathway for patients with metastatic cancer to the lung or stage IV NSCLC and further assess the potential immune modulation and treatment effect of PEF for providing benefit to oncological patients, as outlined below.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aliya PEF | Experimental | Device: Aliya Pulsed Electric Fields (PEF)Pulsed electric field treatment using the Aliya System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient has suspected or confirmed metastatic cancer within the lungs, or stage IV non-small cell lung cancer (NSCLC) requiring biopsy.
- Patient has radiologically documented suspected, or confirmed tumor(s) that are ≤ 5 cm in longest diameter and deemed by the investigator to be suitable per study procedural guidelines for treatment with PEF.
- Patient is deemed eligible to receive 1L SOC therapy for their malignancy.
- In the opinion of the investigator, the patient is not a surgical candidate for curative intent, or the patient has refused surgery.
- Life expectancy ≥ 6 months.
Key exclusion criteria (12 listed)
- Patient has received any prior cancer therapy for current tumor(s) to be treated with PEF.
- Patient is scheduled to receive investigational therapies (including device-based therapy) that may interfere with the study endpoints while on this study.
- Patient has clinical evidence of leptomeningeal disease or brain metastases that require SOC treatment within 4 weeks post-PEF treatment.
- Patient with active, known, or suspected autoimmune disease.
- Patient with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
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 |
|---|---|---|
| Aliya Pulsed Electric Fields (PEF)Percutaneous or Endobronchial PEF | Device | Aliya PEF |
Primary outcome
Device and Procedure related serious adverse events
Time frame: 30 days post PEF
The rate of study device-related and/or PEF procedure-related serious adverse events (SAEs)
Percentage of subjects whose SOC cancer treatment was not cancelled or postponed
Time frame: 1 year Post PEF
The percentage of subjects whose SOC cancer treatment was not cancelled or postponed due to a PEF device- or procedure-related AE
4 secondary outcomes
Procedural success
Time frame: Day of procedure
Anesthesia Type Usage
Time frame: During PEF procedure
PEF Target Location
Time frame: During PEF procedure
Initiation of first-line (1L) SOC therapy following PEF treatment
Time frame: 12 months
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 20 Aug 2025.
- Individual participant dataSharing planned: No
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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.
William Krimsky, MD study chair
Chief Medical Officer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aliya Pulsed Electric Fields (PEF) in people with Lung Neoplasm Malignant, run by Galvanize Therapeutics, Inc. at 5 sites in United States.
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 12 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 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 events (time frame: 30 days post PEF). The study lists 2 primary outcomes in all. 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 20 Aug 2025.