← Back to Search

Device

Chemotherapy + Immunotherapy + PEF Ablation for Non-Small Cell Lung Cancer (VIGOR Trial)

Phase 4
Waitlist Available
Research Sponsored by Galvanize Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is 18 years of age or older
Patient is cleared to undergo paralytic anesthesia
Must not have
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 has recurrent NSCLC or has previously been treated for NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up surgical resection
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study the effects of a cancer treatment combining chemotherapy, immunotherapy, and electric fields on lung cancer.

Who is the study for?
This trial is for adults with early-stage resectable NSCLC who can undergo surgery, tolerate general anesthesia, and have not had cancer treatment in the past 2 years. They must be able to follow the study plan and have a good performance status (ECOG 0-1). Those with recurrent NSCLC, previous lung cancer treatments, or enrolled in conflicting trials cannot join.
What is being tested?
The study tests Aliya PEF ablation followed by standard neoadjuvant therapy including Nivolumab plus Platinum Doublet Chemotherapy before surgical removal of the lung tumor. It's an open-label and non-randomized trial focusing on patients who may benefit from this combined approach.
What are the potential side effects?
Possible side effects include those related to PEF ablation like skin irritation or discomfort at the site of treatment, as well as typical chemotherapy effects such as nausea, fatigue, hair loss, and increased risk of infection. Surgical risks involve complications from anesthesia or postoperative recovery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am approved to have anesthesia that relaxes my muscles.
Select...
My lung cancer is at an early but serious stage and the tumor is no bigger than 5 cm.
Select...
I am fully active or can carry out light work.
Select...
I can safely undergo procedures that require me to be put to sleep.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not part of another clinical trial or using investigational treatments that would interfere with this study.
Select...
My lung cancer has come back or I've been treated for it before.
Select...
I might need surgery to remove one of my lungs.
Select...
My disease is advanced and cannot be removed by surgery.
Select...
I haven't taken drugs for immune system regulation in the last 2 years.
Select...
My scans show a large lymph node or multiple ones in my chest, suggesting my stage IIIA cancer might not be operable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~surgical resection
This trial's timeline: 3 weeks for screening, Varies for treatment, and surgical resection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pathologic response
Secondary study objectives
Heart rate

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Aliya PEF ablationExperimental Treatment4 Interventions
Pulsed electric field treatment using the Aliya System

Find a Location

Who is running the clinical trial?

Galvanize Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
80 Total Patients Enrolled
William Krimsky, MDStudy ChairChief Medical Officer
5 Previous Clinical Trials
159 Total Patients Enrolled

Media Library

Aliya™ PEF Soft Tissue Ablation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05583188 — Phase 4
Non-Small Cell Lung Cancer Research Study Groups: Aliya PEF ablation
Non-Small Cell Lung Cancer Clinical Trial 2023: Aliya™ PEF Soft Tissue Ablation Highlights & Side Effects. Trial Name: NCT05583188 — Phase 4
Aliya™ PEF Soft Tissue Ablation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05583188 — Phase 4
~2 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top