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GMCI + Immunotherapy for Lung Cancer
Study Summary
This trial is testing whether adding a new cancer treatment, Gene Mediated Cytotoxic Immunotherapy (GMCI™), to the standard of care improves response rates and clinical outcomes for patients with stage III/IV non-small cell lung cancer who have stopped responding to their first line of immune checkpoint inhibitor (ICI) treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My blood clotting tests are within safe ranges for an injection procedure.Your liver enzyme levels are not more than 5 times the upper limit of normal, and if they are higher, it doesn't affect your health in a significant way that would stop you from taking the study medication.I have no other cancer needing treatment except for skin cancer.My tumor is pressing on nerves or blood vessels, posing a risk.I have a tumor that can be measured and is suitable for injection.My brain cancer has not responded to treatment, as determined by my doctor.I am willing and able to have biopsies before and during treatment, if possible.I am on strong medication for immune system or arthritis, not including low-dose steroids.I do not have any uncontrolled illnesses that could interfere with the study.I have a lung condition but don't need treatment for it.I have advanced lung cancer and have been on specific immune therapy for at least 18 weeks.I am stable enough to continue my current cancer treatment for at least 12 weeks.I haven't changed or stopped my current immune therapy for more than 4 weeks in the last 6 months.I haven't had or can't have imaging tests using contrast dye.I am not pregnant, breastfeeding, nor plan to become pregnant during the study.I am 18 years old or older.My hemoglobin level is at least 8 g/dl.You have been diagnosed with HIV.Your white blood cell count is at least 1,000 per cubic millimeter.You have had serious side effects from a similar type of treatment in the past.You have had a serious autoimmune disease that needed treatment in the last 2 years.I need more than 2 liters of oxygen per minute to breathe at rest.Your total bilirubin level in your blood should not be too high, unless you have a condition called Gilbert disease, in which case it can be a little higher.I do not have severe heart disease.I haven't taken VEGF inhibitors like bevacizumab in the last 2 months or longer.My kidney function is within the required range.I am fully active or can carry out light work.You have had allergic reactions to valacyclovir or acyclovir in the past.More than half of my liver is affected by cancer spread.I haven't had targeted therapy at more than 3 places in the last year.Your platelet count is at least 75,000 per cubic millimeter.My lung cancer has specific genetic changes or I am on targeted therapy.
- Group 1: Cohorts
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Have there been any other investigations involving this remedy?
"Currently, 5 studies are underway examining this treatment with one in its final Phase 3 stage. These trials are widely dispersed across 127 locations, though many of them are situated near Myrtle Beach, South carolina."
Could you elucidate the number of healthcare facilities carrying out this experiment in Canada?
"Currently, there are 13 clinical trial sites recruiting patients. These locations span cities such as Columbus, Baltimore and Philadelphia in addition to 10 other research centres. It is best for participants to choose the nearest clinic in order to reduce travel demands."
To what degree is this treatment hazardous to patients?
"There is some evidence to suggest the safety of this therapy, so it was given a rating of 2. This trial being Phase 2 indicates that there has not been any clinical data supporting efficacy yet."
Is recruitment for this medical experiment still open?
"Information on clinicaltrials.gov confirms that this trial, which was initially posted in October 2020, is currently seeking participants. The study's details were most recently revised on 10/13/2022."
What is the cap on participants for this clinical research project?
"This clinical trial is seeking out 86 patients that meet the set inclusion criteria. Ohio State University Wexner Medical Center in Columbus, Ohio and University of Maryland, Baltimore are two places where participants can enroll."
Is this an unprecedented scientific endeavor?
"Research on this drug has been ongoing since 2011, when Candel Therapeutics, Inc. sponsored the initial trial of 711 participants. After its Phase 3 approval in 2022, five active clinical trials were initiated; these cover 79 cities and three nations."
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