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NCT04931017 · ClinicalTrials.gov registry record · Phase 2
Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer
A Phase 2 study of Lung Carcinoma, sponsored by Northwestern University.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 4
- Study locations
NCT04931017: Active Phase 2 study of Lung Carcinoma, sponsored by Northwestern University.
NCT04931017 is a Phase 2 study of Lung Carcinoma that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 50 participants, below the 5,042-participant average among 38 other Lung Carcinoma trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04931017, a Phase 2 study of Lung Carcinoma, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase II trial determines the effect of metformin extended release on the risk for developing lung cancer in overweight/obese patients that are at high-risk for developing lung cancer. Metformin is widely used to treat type II diabetes and has a long history of safety and minimal side effects. At similar dosage, the drug may have potential anti-cancer activity. Metformin use has been associated with improved survival in patients with non-small cell lung carcinoma, a specific type of lung cancer, and it has also been shown to enhance immune mobilization against tumors. This trial aims to see whether metformin extended release as a preventative treatment may lower the chance of developing lung cancer, and whether it may help patients' immune system learn ("reprogram") to lower a certain type of immune cell (called regulatory T cells) that are linked to tumor development.
Primary Outcome
Change from pre- to post-metformin extended release (ER) treatment in cell surface PD-1 expression levels of pulmonary (BAL) Tregs, measured as mean fluorescent intensity (MFI). Changes in MFI due to metformin ER treatment among all n = 40 subjects will be used for the primary analysis.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy
- OTHER Questionnaire Administration
- PROCEDURE Bronchoscopy
- DRUG Extended Release Metformin Hydrochloride
Study Locations (4)
British Columbia
- BC Cancer Research Centre - Vancouver
- University of British Columbia Hospital - Vancouver
Colorado
- Rocky Mountain Regional VA Medical Center - Aurora
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-09-09 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What the registry record for NCT04931017 still lists
NCT04931017 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 5,042-participant average among 38 other Lung Carcinoma trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Lung Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04931017 reports a single indexed study location in British Columbia, Colorado, New York.
Frequently Asked Questions
What is clinical trial NCT04931017 about?
NCT04931017 is a clinical study titled "Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer". This phase II trial determines the effect of metformin extended release on the risk for developing lung cancer in overweight/obese patients that are at high-risk for developing lung cancer. Metformin is widely used to treat type II diabetes and has a long history of safety and minimal side effects. ...
What is the current status of trial NCT04931017?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2022-09-09. Estimated completion is 2027-06-30.
What conditions does trial NCT04931017 study?
This clinical trial studies the following conditions: Lung Carcinoma.
What interventions are being tested in trial NCT04931017?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Questionnaire Administration (OTHER), Bronchoscopy (PROCEDURE), Extended Release Metformin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04931017?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04931017 being conducted?
This trial has 4 study locations across Colorado, New York, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04931017's enrollment target sits among peer trials
50 25th of 38 higher than 11 of 38 other Lung Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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