Lung NeoplasmsPhase 2NCT01717482
Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
A Phase 2 study testing Metformin in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to learn whether it is better to receive the drug Metformin with standard of care for lung cancer or just standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 22 May 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (SCC) (must be proven SCC at the time of surgery)
- Medically fit for surgical resection (based on surgeon assessment)
- Current or prior smoker
- Age > 18 years old
- Both Male and Female
- Willing and able to consent to study, undergo study interventions, and take study drug
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
- Subject must start Metformin within 90 days of surgery.
Who cannot join
- Currently taking metformin or other diabetic drugs
- Current or previous congestive heart failure, renal failure or liver failure
- Creatinine in Women of 1.4 or greater and Creatinine in Men of 1.5 or greater
- Existing untreated or prior cancer <5 years from diagnosis
- Received neo-adjuvant platinum-based chemotherapy or targeted therapy
- Receiving adjuvant platinum-based chemotherapy or targeted therapy after surgical resection
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
The purpose of this study is to learn whether it is better to receive the drug Metformin with standard of care for lung cancer or just standard of care.
Read the detailed description
Participants will need to be scheduled to undergo a surgical resection of their lung cancer at the Mayo Clinic in Rochester, Minnesota. They will be asked to provide a blood sample prior to their surgery. Samples of tumor tissue and normal lung tissue will be taken from the samples removed during your lung surgery. The tissue will be used to evaluate DNA. A skin biopsy at the edge of the incision that has already been made will be done during your surgery. We will take the skin and grow skin fibroblasts. Then we will reprogram the skin fibroblasts into induced pluripotent cells. You will be "randomized" into one of the study groups to either take Metformin for 6 months with your standard of care follow up or to receive standard of care follow up.
- Conditions
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
- Being tested
- Metformin, Placebo Comparator
- Keywords
- Bronchoscopy, Metformin
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage
Placebo ComparatorOther
Standard of Care Observation
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Metformin 850mg twice a day Receives: Drug: Metformin |
| Observation | Placebo comparator | Standard of Care Observation Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction
To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected.
Measured: 2 years
Number of Participants With 2-year Recurrence Free Survival
To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.
Measured: 4 years
Secondary outcomes (2)
Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)
To develop the metformin sensitivity index based on iPS cell line metformin sensitivity measurements from the first 20 patients randomized to the metformin arm. We will then To apply the metformin sensitivity index on the remaining 25 patients randomized to metformin and the 45 observation patients (70 patients total) to compare the 2-year RFS rate between metformin-sensitive and metformin-not-sensitive patients.
Measured: 4 years
Number of Participants With Adverse Events as a Measure of Safety
To compare participant adverse events between metformin and observation arms using CTCAE version 4.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completion22 May 2019
- Study completion22 May 2019
Why it stopped: Poor accrual and funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Clinical Trials in Oncology
- Responsible party
- Principal investigator, Dennis Wigle, Mayo Clinic
- Investigators
- Dennis Wigle, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717482
- Sponsor's protocol ID
- 12-006865
- Status last verified
- Mar 2020
- First submitted
- 25 Oct 2012
- Last updated
- 10 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01717482
- Acronym / sponsor ID
- 12-006865
- Conditions
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
- Keywords
- Bronchoscopy, Metformin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual and funding ended
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Alliance for Clinical Trials in Oncology
- Study start
- Oct 2012
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn whether it is better to receive the drug Metformin with standard of care for lung cancer or just standard of care.
Detailed description
Participants will need to be scheduled to undergo a surgical resection of their lung cancer at the Mayo Clinic in Rochester, Minnesota. They will be asked to provide a blood sample prior to their surgery. Samples of tumor tissue and normal lung tissue will be taken from the samples removed during your lung surgery. The tissue will be used to evaluate DNA. A skin biopsy at the edge of the incision that has already been made will be done during your surgery. We will take the skin and grow skin fibroblasts. Then we will reprogram the skin fibroblasts into induced pluripotent cells. You will be "randomized" into one of the study groups to either take Metformin for 6 months with your standard of care follow up or to receive standard of care follow up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminMetformin 850mg twice a day |
| Observation | Placebo comparator | Other: Placebo ComparatorStandard of Care Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (SCC) (must be proven SCC at the time of surgery)
- Medically fit for surgical resection (based on surgeon assessment)
- Current or prior smoker
- Age > 18 years old
- Both Male and Female
Key exclusion criteria (6 listed)
- Currently taking metformin or other diabetic drugs
- Current or previous congestive heart failure, renal failure or liver failure
- Creatinine in Women of 1.4 or greater and Creatinine in Men of 1.5 or greater
- Existing untreated or prior cancer <5 years from diagnosis
- Received neo-adjuvant platinum-based chemotherapy or targeted therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Glucophage | Drug | Metformin |
| Placebo ComparatorStandard of Care Observation | Other | Observation |
Primary outcome
Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction
Time frame: 2 years
To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected.
Number of Participants With 2-year Recurrence Free Survival
Time frame: 4 years
To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.
2 secondary outcomes
Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)
Time frame: 4 years
Number of Participants With Adverse Events as a Measure of Safety
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Wigle, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.