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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

Must not have

Participants currently using immunosuppressive medication, including systemic steroids (not inhalational) and episodic use of inhaled steroids are excluded from this trial due to the potential impact of these treatments on the primary trial endpoint

Current or previous diagnosis of diabetes mellitus (type I or type II diabetes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to week 26

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any immunosuppressive medication, including systemic steroids.

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I have been diagnosed with diabetes (type 1 or type 2).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to study completion

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PD-1 expression of pulmonary regulatory T cells (Tregs) before and after metformin extended release (ER) treatment

Secondary study objectives

Circulating immune cells

Estimated PD-1 expression of pulmonary Tregs change in cohort B during the wait period (6 months with no treatment)

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1150