An Early Phase 1 interventional study of Metformin in Thoracic Neoplasm, sponsored by Dartmouth-Hitchcock Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by Dartmouth-Hitchcock Medical Center · Early Phase 1, Interventional, and Basic science
Among 52 studies in Thoracic Neoplasms with a site in United States — 12 open to participants now, 18 under way, 1 of them phase 3. Thoracic Neoplasms · United States.
Among the 52 studies in Thoracic Neoplasms with a site in United States, this one is the 35th largest by enrollment of the 44 interventional ones that give a count, is one of 3 that started in 2018, is one of 15 in phase 1, and was the 21st registered.
115 studies on the registry are indexed under Thoracic Neoplasms; 30 are open to participants now.
Browse Thoracic Neoplasms studies →12 of the 52 studies in Thoracic Neoplasms with a site in United States are open now. Recruiting first, the newest first:
UNC Lineberger Comprehensive Cancer Center · Sites in United States
Ages 18+
MediLink Therapeutics (Suzhou) Co., Ltd. · Sites in United States, Belgium, France and 6 more countries
Ages 18+
UNC Lineberger Comprehensive Cancer Center · Sites in United States
Ages 18+
Rutgers, The State University of New Jersey · Sites in United States
Ages 50–77 · Healthy volunteers
Eli Lilly and Company · Sites in United States, Australia, Austria and 26 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 27 Thoracic Neoplasms studies recruiting now, 18 (67%) set no upper age limit and 6 (22%) stop at 75 or younger; 1 takes children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
52 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 13 · Phase 3 3 · Phase 4 2
First in 2007; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 18 is below the median of 61 across 86 interventional studies indexed under Thoracic Neoplasms.
Median enrollment 59 across the 44 interventional studies, 192 across the 8 observational. Of the 31 that completed or were terminated, 11 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 52 have an industry lead sponsor. The 10 most frequent:
Dartmouth-Hitchcock Medical Center is the lead sponsor of 488 studies on the registry; 71 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.
Dartmouth-Hitchcock Medical Center has 1 study filed under Thoracic Neoplasms — fewer than ten, so there is no comparison to draw.
9 of the studies in Thoracic Neoplasms with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06119581Phase 3Eli Lilly and CompanyA Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer | 2027-11 |
| NCT05521789George Washington UniversityErector Spinae Block for Thoracic Surgery | 2026-12-21 |
| NCT05462717Revolution Medicines, Inc.Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors | 2027-03-31 |
| NCT07455513Ohio State University Comprehensive Cancer CenterA Novel Tobacco Cessation Resource for Smokers With a Diagnosed or Suspected Thoracic Cancer | 2027-03-31 |
| NCT07776353Kaiser PermanenteUnderstanding New Cachexia Subtypes Through Observational Epidemiological Research | 2027-05 |
Among the 52 studies in Thoracic Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a presurgical (proof of principle, window of opportunity) study in patients with surgically resectable thoracic tumors to determine steady-state tissue and plasma concentrations of metformin.
To understand the variability in clinical results testing metformin as an anti-cancer agent, it is important to determine the concentrations of metformin that are achievable in tissue. Clinical effects of metformin develop gradually over several days of treatment. Steady-state plasma metformin concentrations are correlated with anti-hyperglycemic response. Thus, achieving steady-state concentrations in this study will allow accurate determination of the most representative concentrations of metformin in normal and cancerous tissues, as well as determine AMP-activated protein kinase (AMPK) signaling differences in these tissues. As tha Primary Objective is to determine the concentration of metformin in tumors, patients will be treated with metformin extended release (ER) (Glucophage® XR), starting at 750 milligrams (mg) oral (PO) once daily (QD) for 4 days, then escalating to 750 mg PO twice daily (BID) for 3-6 days prior to surgery. FDA prescribing information indicates that metformin reaches steady-state plasma concentrations within 24-48 hours after the start of dosing in humans; thus, the 7-to-10-day time frame of this study will allow sufficient time for metformin to reach steady-state plasma concentrations, in addition to time allotted for potential accumulation in tissues. Metformin concentrations will be measured using a validated liquid chromatography-mass spectrometry (LC-MS/MS) assay.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must meet the following clinical laboratory criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients enrolled will be treated with metformin (administered orally; 750 mg QD for 4 days, then 750 mg BID for 3-6 days; or clinically indicated metformin) for a total of 7-10 days prior to surgery, up until the night before surgery.
Drug: Metformin
Metformin will be given to patients prior to surgery.
Lung Tumor Tissue Concentration of Metformin
To determine the intra-tumor concentrations of metformin, with a standard deviation ≤25% of the mean, in patients with solid tumors of thoracic origin administered metformin extended release.
Time frame: Within 7 days from surgery
Concentration of Metformin in Adipose Tissue
To determine the concentration of metformin in adipose tissue.
Time frame: Within 7 days from surgery
Concentration of Metformin in Tumor-adjacent Normal Tissue
To determine the concentration of metformin in tumor-adjacent normal tissue.
Time frame: Within 7 days from surgery
Concentration of Metformin in Plasma.
To determine the concentration of metformin in plasma.
Time frame: Within 7 days from surgery
Concentration of Metformin in Whole Blood.
To determine the concentration of metformin in whole blood.
Time frame: Within 7 days from surgery
AMPK Activity Alterations.
To determine whether metformin alters AMPK activity in tumor cells.
Time frame: Within 7 days from surgery.
| Milestone | Metformin | Control |
|---|---|---|
| Started | 17 | 1 |
| Completed | 14 | 1 |
| Not completed | 3 | 0 |
To determine the intra-tumor concentrations of metformin, with a standard deviation ≤25% of the mean, in patients with solid tumors of thoracic origin administered metformin extended release.
| ng/g | Metformin |
|---|---|
| Lung Tumor Tissue Concentration of Metformin | 1290 (33 to 4445) |
To determine the concentration of metformin in adipose tissue.
| ng/g | Metformin |
|---|---|
| Concentration of Metformin in Adipose Tissue | 70 (45 to 285) |
To determine the concentration of metformin in tumor-adjacent normal tissue.
| ng/g | Metformin |
|---|---|
| Concentration of Metformin in Tumor-adjacent Normal Tissue | 749 (44 to 3013) |
To determine the concentration of metformin in plasma.
| ng/mL | Metformin |
|---|---|
| Concentration of Metformin in Plasma. | 450 (18 to 6179) |
To determine the concentration of metformin in whole blood.
| ng/mL | Metformin |
|---|---|
| Concentration of Metformin in Whole Blood. | 514 (3 to 4238) |
To determine whether metformin alters AMPK activity in tumor cells.
No measurements were reported for this outcome.
Collected over Events were collected from the time of consent until the day after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metformin | 0/14 (0%) | 0/14 (0%) | 1/14 (7.1%) |
| Control | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | Metformin | Control |
|---|---|---|
| diarrheaGastrointestinal disorders | 1/14 | 0/1 |
| Age, Continuous(years) | Metformin | Control | Total |
|---|---|---|---|
| Mean | 70.9 ± 6.0 | 75 | 70.9 ± 7.2 |
| Sex: Female, Male(Participants) | Metformin | Control | Total |
|---|---|---|---|
| Female | 9 | 0 | 9 |
| Male | 5 | 1 | 6 |
| Race (NIH/OMB)(Participants) | Metformin | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 14 | 1 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Metformin | Control | Total |
|---|---|---|---|
| United States | 14 | 1 | 15 |
| Subject already taking metformin at time of study entry(Participants) | Metformin | Control | Total |
|---|---|---|---|
| Count of participants | 13 | 0 | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2018 to primary completion in Nov 2021, 42 months.
Results were first posted in Oct 2023, 1 year 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin
Dartmouth-Hitchcock Medical Center →