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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up surgical resection
Awards & highlights
VIGOR 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.Check my eligibility
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.See study design
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.
VIGOR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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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.
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I am fully active or can carry out light work.
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I can safely undergo procedures that require me to be put to sleep.
VIGOR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ surgical resection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~surgical resection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic response
Secondary outcome measures
Heart rate
VIGOR Trial Design
1Treatment groups
Experimental Treatment
Group I: Aliya PEF ablationExperimental Treatment4 Interventions
Pulsed electric field treatment using the Aliya System
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Who is running the clinical trial?
Galvanize Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
73 Total Patients Enrolled
William Krimsky, MDStudy ChairChief Medical Officer
5 Previous Clinical Trials
159 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- A study doctor thinks I can have surgery to remove lung cancer.I am 18 years old or older.I am not part of another clinical trial or using investigational treatments that would interfere with this study.My lung cancer is at an early but serious stage and the tumor is no bigger than 5 cm.I am approved to have anesthesia that relaxes my muscles.I have not received any vaccines within the last 30 days.I am fully active or can carry out light work.I have had cancer treatment, including chemotherapy, within the last 2 years.My lung cancer has come back or I've been treated for it before.I might need surgery to remove one of my lungs.My disease is advanced and cannot be removed by surgery.I can safely undergo procedures that require me to be put to sleep.My lesion can be biopsied and treated according to my doctor.I haven't taken drugs for immune system regulation in the last 2 years.My scans show a large lymph node or multiple ones in my chest, suggesting my stage IIIA cancer might not be operable.I am considered fit for initial cancer treatment based on my cancer's genetic features.
Research Study Groups:
This trial has the following groups:- Group 1: Aliya PEF ablation
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Aliya PEF ablation hazardous for people's health?
"Aliya PEF ablation has been approved and is thus rated a 3 on the 1-3 scale of safety."
Answered by AI
Are researchers currently seeking more participants for this trial?
"According to records from clinicaltrials.gov, this research project is no longer recruiting candidates - the initial post was made on November 1st of 2022 and it has since been duly updated as recently as October 24th of 2022. However, there are currently 1529 other trials that are still enrolling patients for participation."
Answered by AI
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