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Non-small Cell Lung CancerPhase 2NCT01997775

Metformin in Stage IV Lung Adenocarcinoma

A Phase 2 study testing METFORMIN in people with Non-small Cell Lung Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine whether metformin is effective in lowering plasma IL-6 level and improving the treatment response in patients with non-small cell lung cancer Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
METFORMIN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteTaiwan
Study dates
Aug 2013to Jun 2016
Phase
Phase 2
Are there results?
None posted in the registry

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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed lung adenocarcinoma.
  • Stage IV disease as defined by AJCC 7th edition staging.
  • At least one measurable lesion (as defined by RECIST v1.1).
  • No prior radiotherapy, chemotherapy, surgery, target therapy, or immunotherapy for NSCLC. (Except the surgery for biopsy or port-A implantation, palliative localized radiotherapy for bone metastasis).
  • Age ≤ 80 years old and ≥ 20 years old.
  • ECOG performance status of 0-2.
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  • Adequate organ function, including followings
  • Bone marrow:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; WBC ≥ 3.0 x 10^9/L Platelet count ≥ 100 x 10^9/L Hemoglobin ≥ 9g/dL
  • Hepatic:
  • Total bilirubin level ≤ 1.0 x UNL AST and ALT ≤ 3.0 x UNL;
  • Renal:
  • Creatinine level ≤ 1.5 mg/dL in men, ≤1.4 mg/dL in women; or Estimated CCr ≥ 60 mL/min. (CCr is estimated by Cockcroft-Gault formula, as appendix II)(CCr is estimated by Cockcroft-Gault formula)
  • Estimated life expectancy of at least 6 months.
  • Written (signed) Informed Consent.

Who cannot join

  • With other primary malignancies, except those remain disease-free for 3 or more years after curative treatment, basal cell cancer of the skin or in situ cervical cancer.
  • Use of other anti-cancer therapy, including chemotherapy, target therapy, immunotherapy, radiotherapy, and hormone therapy.
  • Prior participation in any investigational drug study within 28 days.
  • Use of anti-IL-6 or IL-6-lowering agents.
  • Use of metformin in the past 6 months.
  • Poor controlled diabetes (HbA1c ≥ 8.0%).
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  • Known hypersensitivity or intolerance to metformin.
  • Congestive heart failure with NYHA functional class II~IV.
  • History of lactic acidosis.
  • Significant concurrent medical diseases, such as unstable angina, acute or recent myocardial infarction (< 6 months before enrollment), COPD with frequent exacerbation, uncontrolled hypertension, or recent CVA (< 6 months before enrollment).
  • Active uncontrolled infections or HIV infection.
  • Psychiatric disorders that would compromise the patient's compliance or decision.
  • Current or planned pregnancy, or breast feeding in women.
  • Poor compliance.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704

Other trials in Taiwan

About this study

Official title: A Phase II Trial to Examine the Effect of Metformin on Plasma IL-6 Level in Patients With Advanced Non-Small Cell Lung Cancer

The purpose of this study is to determine whether metformin is effective in lowering plasma IL-6 level and improving the treatment response in patients with non-small cell lung cancer

Read the detailed description

Interleukin-6 (IL-6) plays an important role in the pathogenesis of lung cancer. Several clinical studies show metformin could decrease IL-6 level in addition to the glucose-lowering effect. Preclinical data also reveal metformin could decrease the IL-6 production in lung cancer cells and enhance cytotoxicity of chemotherapy in animal model. Based on these findings, the purpose of this study is to determine whether metformin is effective in lowering plasma IL-6 level and improving the treatment response in patients with non-small cell lung cancer clinically. Patients with stage IV lung adenocarcinoma will be enrolled in this study and receive standard treatments for lung cancer, either chemotherapy combining cisplatin and pemetrexed or targeted therapy (Gefitinib). For patients with plasma IL-6 more than 2.0 pg/ml after 2 cycles of standard treatment, metformin will be given and titrated to 1500mg/day gradually. Plasma IL-6 level will be checked after use of metformin for 12 weeks. Tumor response to the standard treatment plus metformin will be evaluated and side effects of metformin will also be monitored.

Being tested
METFORMIN
Keywords
IL-6, Metformin, Non-small cell lung cancer, Lung adenocarcinoma
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • METFORMINDrug

    Also called GLUCOPHAGE

    Participants enrolled in this study will be treated with either chemotherapy (Cisplatin 75mg/m2 plus Pemetrexed 500mg/m2 on D1) for 4 cycles or targeted therapy (Gefitinib 250mg/d) till disease progression according to physicians' decision. For participants with plasma IL-6 > 2.0 pg/mL after 2 cycles of chemotherapy or targeted therapy, Metformin 500mg orally qd will be given on Day 1 of cycle 3. If patient could tolerate it well, metformin will be titrated to 500mg bid in the following week (Cycle 3 D8) and 500mg tid in the 3rd week (Cycle 3 D15). For patients receiving chemotherapy, metformin will be used for total 12 weeks and plasma IL-6 level will be checked at the end of metformin treatment. For patients receiving targeted therapy, metformin will be used till disease progression and plasma IL-6 level will be measured after use of metformin for 12 weeks.

Study groups in NCT01997775
Study groupRoleWhat they receive
METFORMINExperimentalFor patients with stage IV lung adenocarcinoma and IL-6 level higher than 2.0 pg/ml after 2 cycles of standard treatment, metformin 500mg tid orally will be given.
Receives: Drug: METFORMIN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change of plasma IL-6 level after the treatment with metformin

    Measured: 12 weeks

Secondary outcomes (5)

  1. The objective response rate (RR)

    Measured: 2 YEARS

  2. The progression free survival

    Measured: 2 years

  3. The overall survival

    Measured: 2-years

  4. Number of participants with adverse events

    All adverse events (AEs) occurring after the patient receiving the first dose of study drug will be monitored and recorded. Periodic measurement of vital signs, regular laboratory evaluation for hematology and blood chemistry will be arranged and these will be graded by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grades.

    Measured: 2-years

  5. Changes of quality of life

    The quality of life will be evaluated by the EQ-5D-3L questionnaire which will be completed at baseline, during the therapy, and post-therapy period

    Measured: 2-years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionJun 2016
  4. Study completionJun 2016

Why it stopped: Difficult enrollment

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01997775
Sponsor's protocol ID
B-BR-102-039
Status last verified
Sep 2016
First submitted
17 Nov 2013
Last updated
30 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing METFORMIN in people with Non-small Cell Lung Cancer, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

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 15 inclusion and 14 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 30 Sep 2016. 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 Taiwan. 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. 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?

The study was stopped early (reason given: Difficult enrollment). Results are not available in the source record.

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?

The change of plasma IL-6 level after the treatment with metformin (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01997775.

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 30 Sep 2016.

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