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Anti-diabetic drug

Metformin for Lung Cancer Prevention in Overweight or Obese Individuals

Phase 2
Recruiting
Led By Saikrishna S Yendamuri
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Estimated glomerular filtration rate (eGFR) > 45 ml/min/1.73 m^2 (eGFR will be calculated using the equation Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine)
Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to week 26
Awards & highlights

Study Summary

This trial is testing whether metformin extended release may help prevent lung cancer, and whether it may help the immune system learn to lower a type of immune cell that is linked to tumor development.

Who is the study for?
This trial is for overweight or obese adults over 30 years old at high risk for lung cancer, with a specific lung cancer risk score and no history of diabetes. They must have quit smoking for at least a year, have normal organ function tests, and agree to use contraception. People with previous metformin use, certain medical conditions like severe liver disease or heart failure, or those on immunosuppressive drugs can't join.Check my eligibility
What is being tested?
The study is testing if extended release Metformin can prevent lung cancer in high-risk individuals by possibly reprogramming the immune system to reduce harmful cells linked to tumors. Participants will undergo bronchoscopy, biopsies and give biospecimens while taking Metformin and answering questionnaires about their health.See study design
What are the potential side effects?
Metformin is known for its safety with minimal side effects which may include digestive issues like nausea or diarrhea, slight risk of vitamin B12 deficiency over time, and very rarely a condition called lactic acidosis where too much acid builds up in the blood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by eGFR, is above 45.
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I am on long-term antiviral treatment for herpes.
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I can take care of myself and am up and about more than half of the day.
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I had hepatitis C but have been treated and cured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to study completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PD-1 expression of pulmonary regulatory T cells (Tregs) before and after metformin extended release (ER) treatment
Secondary outcome measures
Circulating immune cells
Estimated PD-1 expression of pulmonary Tregs change in cohort B during the wait period (6 months with no treatment)
Other outcome measures
Airway gene expression
Examination of the effect of metformin on systemic adipokines and inflammatory cytokines
Examination of the immune profile of pulmonary parenchyma represented by bronchoalveolar lavage
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cohort A (metformin ER)Experimental Treatment5 Interventions
Participants receive metformin ER PO QD for 26 weeks in the absence of unacceptable toxicity. Participants undergo bronchoscopy biopsy and blood sample collection at screening, and week 13.
Group II: Cohort B (metformin ER with waiting period)Active Control5 Interventions
Participants receive no intervention for 26 weeks, then cross-over to Cohort A. Participants undergo bronchoscopy biopsy and blood sample collection at screening, at week 26, and at 13 weeks after cross-over to Cohort A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bronchoscopy
2002
Completed Phase 2
~2300
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,804 Total Patients Enrolled
Saikrishna S YendamuriPrincipal InvestigatorRoswell Park University
1 Previous Clinical Trials
220 Total Patients Enrolled

Media Library

Metformin (Anti-diabetic drug) Clinical Trial Eligibility Overview. Trial Name: NCT04931017 — Phase 2
Lung Cancer Research Study Groups: Cohort A (metformin ER), Cohort B (metformin ER with waiting period)
Lung Cancer Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT04931017 — Phase 2
Metformin (Anti-diabetic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04931017 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For which conditions is Extended Release Metformin Hydrochloride commonly prescribed?

"Extended Release Metformin Hydrochloride is commonly prescribed as an adjuvant to exercise regimes. It also has the potential to treat a range of conditions, including type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."

Answered by AI

What is the current enrollment capacity for this medical research?

"Affirmative. According to the data hosted on clinicaltrials.gov, this trial is currently seeking participants, having first been posted on March 18th 2022 and edited most recently in September 20th that same year. The experiment requires 50 subjects from 5 different sites."

Answered by AI

Are there any prior studies that have utilized Extended Release Metformin Hydrochloride?

"Currently, 170 clinical trials are investigating Extended Release Metformin Hydrochloride; 43 of these studies have entered the Phase 3 stage. Although a majority of them originate in Pittsburgh, Pennsylvania, 1902 trial sites across the globe are participating."

Answered by AI

Are multiple healthcare establishments in the US conducting this trial?

"Currently, this medical trial is calling for volunteers from 5 distinct sites. These locales are scattered across the continent and include Buffalo, Chicago, Vancouver amongst others; thus it would be prudent to select a location nearby in order to attenuate travel requirements."

Answered by AI

Has Extended Release Metformin Hydrochloride attained regulatory authorization?

"Our risk assessment score for Extended Release Metformin Hydrochloride is 2. As this medical trial only has Phase 2 data, we have evidence of safety but not efficacy."

Answered by AI

Are there any opportunities to take part in this trial at the current time?

"As per the data found on clinicaltrials.gov, this experiment is currently in search of participants. It was first posted on March 18th 2022 and its most recent update was released September 20th 2022."

Answered by AI

Who else is applying?

What state do they live in?
California
Pennsylvania
Georgia
What site did they apply to?
University of Colorado
Roswell Park Cancer Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer
2022. "Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04931017.
All > Lung Cancer Chicago
~27 spots leftby Apr 2026
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