Cancer of Lung, Kidney or LiverINCITE LSNCT04773275
A Clinical Evaluation of the Aliya™ System in Late Stage Cancer
A study testing Pulsed electric field treatment using the Aliya system in people with Cancer of Lung, Kidney or Liver, run by Galvanize Therapeutics, Inc. at 3 sites in 3 countries.
Trial summary
A prospective, single-arm, non-randomized, multi-center, open-label study following patients to 1 year. The study is designed to evaluate the safety and clinical utility of Pulsed Electric Field (PEF) treatment of advanced stage or metastatic cancer following progression on immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Lung, Kidney or Liver
- 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
- 4 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 9 May 2022to 21 Apr 2023
- 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
- Patient is eligible for inclusion if diagnosed and currently under physician care for one of the following advanced stage or metastatic conditions:
- Stage IV non-small cell lung cancer
- Stage IV hepatocellular carcinoma
- Stage IV renal cell carcinoma
- Patient is currently receiving PD-1/PD-L1 axis immunotherapy as their most recent line of therapy, either alone or in combination with standard of care systemic therapy for their malignancy.
- Patient has exhibited at least 6 months of response to PD-1/PD-L1 axis immunotherapy regimen (defined as complete response (CR), partial response (PR), or stable disease (SD) in their index tumors per RECIST 1.1) prior to progression.
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- Patient has radiologically documented or confirmed progressive disease (per RECIST 1.1) defined as a total of ≤ 5 new areas of growth on existing tumors and/or new tumors.
- New tumors must be ≤ 2cm in longest diameter. New areas of growth on existing tumors must be ≤ 2cm in longest diameter. Tumors and new areas of growth must be deemed suitable by the investigator for complete treatment with PEF. Pathologic lymph nodes must be ≥ 15mm in short axis.
- In the judgement of the investigator, the patient is able to remain on PD-1/PD-L1 axis immunotherapy for at least 3 months after PEF treatment.
- New tumors and areas of growth on existing tumors are amenable to core or forceps biopsy in order to confirm disease progression.
- Patient must be willing to undergo tumor biopsy at PEF treatment delivery.
- Patient refuses surgery and/or stereotactic body radiotherapy (SBRT).
- Life expectancy ≥ 12 weeks.
- ECOG performance status 0-1
Who cannot join
- Patient has implanted lung devices or electronic devices.
- Patient is receiving bevacizumab concurrently with their PD-1/PD-L1 axis immunotherapy.
- Patient has received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) in another study within 21 days prior to study enrollment.
- Patient is scheduled to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for off-label cancer treatment while on this study.
- Patient has unresolved adverse reaction to immunotherapy that requires dose modification.
- Patient has received any radiation therapy within 6 weeks prior to study enrollment.
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- Patient has leptomeningeal disease or active brain metastases that are not clinically controlled and asymptomatic for at least 14 days following treatment and prior to study enrollment or has residual neurological dysfunction and has not been off corticosteroids for at least seven days prior to study enrollment.
- Patient has an active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). 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
- Patient has received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within seven 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 any history of organ transplant that requires use of immunosuppressives.
- Patient has clinical signs or symptoms of active tuberculosis infection.
- Patient has history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease.
- Patient has documented evidence of acute hepatitis or has an active or uncontrolled infection.
- Patient has undergone major surgery within 28 days prior to study enrollment or has planned for other major surgery to be performed while enrolled in the clinical trial.
- Patient is unable or unwilling to complete all required screening and/or follow-up assessments.
- Patient is currently enrolled in another interventional clinical trial or is receiving treatment with an investigational medication or medical device that conflicts with the study protocol.
- Patient for whom the investigator considers that the PEF treatment is not in the patient's best interest.
- Patient has active alcohol or drug addiction or any other condition that, in the investigator's opinion, would interfere with their ability to comply with the study requirements.
- Patient has any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: INCITE LS: A Clinical Evaluation of the Aliya™ System in Late Stage Cancer
A prospective, single-arm, non-randomized, multi-center, open-label study following patients to 1 year. The study is designed to evaluate the safety and clinical utility of Pulsed Electric Field (PEF) treatment of advanced stage or metastatic cancer following progression on immunotherapy.
Read the detailed description
This study is designed to evaluate the safety and clinical utility of Pulsed Electric Field (PEF) treatment of advanced stage or metastatic cancer following progression on immunotherapy. The study will enroll adult patients with confirmed 8th ed. Stage IV non-small cell lung cancer (NSCLC), Stage IV renal cell carcinoma (RCC), or Stage IV hepatocellular carcinoma (HCC), who have experienced a response to checkpoint inhibitor (CPI) therapy (complete response (CR), partial response (PR), or stable disease (SD) as per RECIST 1.1) for a minimum of 6 months, and have documented radiologic progression (progressive disease (PD) as defined by RECIST 1.1) in up to five sites (non-central nervous system). PEF treatment delivery is to be performed in conjunction with the clinically appropriate approach to collect standard of care biopsy samples to confirm disease progression. The PI has the discretion to approach via endoluminal or percutaneous method if the target(s) is/are amenable. PEF treatment will be delivered to accessible new areas of growth on existing tumors or new tumors.
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 compatible commercially available TBNA Needle 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 at up to 5 clinical sites.
- Conditions
- Cancer of Lung, Kidney or Liver
- Being tested
- Pulsed electric field treatment using the Aliya system
- Medical subject headings
- Lung Neoplasms
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
Patients will undergo pulsed electric field (PEF) treatment of up to 5 tumors (new or progressing) measuring ≤ 2cm in longest diameter.
| Study group | Role | What they receive |
|---|---|---|
| Aliya PEF treatment | Experimental | Not described Receives: Device: Pulsed electric field treatment using the Aliya system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device and Procedure serious adverse event rate
The rate of system-related and procedure-related serious adverse events (SAEs)
Measured: 30 days
Radiologic local control
Frequency of radiological assessment of response of PEF-treated tumors and lymph nodes (e.g., change in longest diameter of tumor, change in short axis of lymph node)
Measured: 90 days
Secondary outcomes (2)
Immunologic response: lymphocytes
Changes from baseline in lymphocytes (CD3+, CD4+, CD8+, Treg, NK, Neutrophils MDSC; all analyzed as cells per mL)
Measured: all time points up to 1 year
Immunologic response: cytokines
Changes from baseline in serum levels of cytokines (IL-2, IL-6, IL-10, IL-12; all analyzed as concentration in pg / mL) from blood samples
Measured: all time points up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start9 May 2022
- Primary completion23 Feb 2023
- Study completion21 Apr 2023
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of Lung, Kidney or LiverStudies 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
- Model description
- Single cohort consecutive case series
- Masking
- None (open label)
- Enrolment
- 4 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
- NCT04773275
- Sponsor's protocol ID
- CSP-00010
- Acronym
- INCITE LS
- Status last verified
- Jul 2025
- First submitted
- 22 Feb 2021
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jimenez M, Fernandez JM, Krimsky WS. Pulsed Electric Field (PEF) treatment of progressive non-small cell lung cancer concurrently treated with immune checkpoint blockade: A case report. Respir Med Case Rep. 2024 Mar 29;49:102018. doi: 10.1016/j.rmcr.2024.102018. eCollection 2024.
PubMed 38601720
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INCITE LS: A Clinical Evaluation of the Aliya™ System in Late Stage Cancer
- ClinicalTrials.gov ID
- NCT04773275
- Acronym / sponsor ID
- INCITE LS / CSP-00010
- Conditions
- Cancer of Lung, Kidney or Liver
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Galvanize Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 26 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, single-arm, non-randomized, multi-center, open-label study following patients to 1 year. The study is designed to evaluate the safety and clinical utility of Pulsed Electric Field (PEF) treatment of advanced stage or metastatic cancer following progression on immunotherapy.
Detailed description
This study is designed to evaluate the safety and clinical utility of Pulsed Electric Field (PEF) treatment of advanced stage or metastatic cancer following progression on immunotherapy. The study will enroll adult patients with confirmed 8th ed. Stage IV non-small cell lung cancer (NSCLC), Stage IV renal cell carcinoma (RCC), or Stage IV hepatocellular carcinoma (HCC), who have experienced a response to checkpoint inhibitor (CPI) therapy (complete response (CR), partial response (PR), or stable disease (SD) as per RECIST 1.1) for a minimum of 6 months, and have documented radiologic progression (progressive disease (PD) as defined by RECIST 1.1) in up to five sites (non-central nervous system). PEF treatment delivery is to be performed in conjunction with the clinically appropriate approach to collect standard of care biopsy samples to confirm disease progression. The PI has the discretion to approach via endoluminal or percutaneous method if the target(s) is/are amenable. PEF treatment will be delivered to accessible new areas of growth on existing tumors or new tumors.
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 compatible commercially available TBNA Needle 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 at up to 5 clinical sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single cohort consecutive case series
| Arm | Type | Receives |
|---|---|---|
| Aliya PEF treatment | Experimental | Device: Pulsed electric field treatment using the Aliya system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient is eligible for inclusion if diagnosed and currently under physician care for one of the following advanced stage or metastatic conditions:
- Patient is currently receiving PD-1/PD-L1 axis immunotherapy as their most recent line of therapy, either alone or in combination with standard of care systemic therapy for their malignancy.
- Patient has exhibited at least 6 months of response to PD-1/PD-L1 axis immunotherapy regimen (defined as complete response (CR), partial response (PR), or stable disease (SD) in their index tumors per RECIST 1.1) prior to progression.
- Patient has radiologically documented or confirmed progressive disease (per RECIST 1.1) defined as a total of ≤ 5 new areas of growth on existing tumors and/or new tumors.
- New tumors must be ≤ 2cm in longest diameter. New areas of growth on existing tumors must be ≤ 2cm in longest diameter. Tumors and new areas of growth must be deemed suitable by the investigator for complete treatment with PEF. Pathologic lymph nodes must be ≥ 15mm in short axis.
Key exclusion criteria (20 listed)
- Patient has implanted lung devices or electronic devices.
- Patient is receiving bevacizumab concurrently with their PD-1/PD-L1 axis immunotherapy.
- Patient has received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) in another study within 21 days prior to study enrollment.
- Patient is scheduled to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for off-label cancer treatment while on this study.
- Patient has unresolved adverse reaction to immunotherapy that requires dose modification.
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 systemPatients will undergo pulsed electric field (PEF) treatment of up to 5 tumors (new or progressing) measuring ≤ 2cm in longest diameter. | Device | Aliya PEF treatment |
Primary outcome
Device and Procedure serious adverse event rate
Time frame: 30 days
The rate of system-related and procedure-related serious adverse events (SAEs)
Radiologic local control
Time frame: 90 days
Frequency of radiological assessment of response of PEF-treated tumors and lymph nodes (e.g., change in longest diameter of tumor, change in short axis of lymph node)
2 secondary outcomes
Immunologic response: lymphocytes
Time frame: all time points up to 1 year
Immunologic response: cytokines
Time frame: all time points up to 1 year
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Background: PubMed 38601720Jimenez M, Fernandez JM, Krimsky WS. Pulsed Electric Field (PEF) treatment of progressive non-small cell lung cancer concurrently treated with immune checkpoint blockade: A case report. Respir Med Case Rep. 2024 Mar 29;49:102018. doi: 10.1016/j.rmcr.2024.102018. eCollection 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 Cancer of Lung, Kidney or Liver, run by Galvanize Therapeutics, Inc. at 3 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 14 inclusion and 20 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: stopped early, as of the sponsor's last update on 1 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 3 sites in Hong Kong, Netherlands, Spain. 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 was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
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 serious adverse event rate (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT04773275, which also lists 1 linked publication.
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 1 Aug 2025.