A Phase 2 interventional study of Metformin in Non Small Cell Lung Cancer and Lung Cancer, sponsored by University Health Network, Toronto. Completed at 2 sites in Canada. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-19.
Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment
This is a phase II single centre open label single arm pre-operative window of metformin treatment in stage I-IIIa Non small cell lung cancer.
In which patients will be invited to participate by receiving Metformin treatment during 14 to 21 days at 850 mg BID until the day before surgery.
They will be followed closely for any Adverse Events during treatment and 30 days after surgery. During treatment there will be no follow up tests except 1 fasting blood glucose at week 2 of treatment.
Survival data will be prospectively gathered after study treatment has ended until death.
Title of study: Phase II study of single agent pre-operative metformin in patients with clinical stage I - IIIA NSCLC proceeding to surgical resection. 'Lung Metcore Study'
Objectives:
To evaluate the effects of short-term pre-operative exposure to metformin in operable stages I to IIIA NSCLC.
Primary end-points:
Secondary end-points:
Number of patients: Thus, the total expected sample size is approximately 50 patients, anticipating minimal loss of eligible participants through treatment intolerance or acceleration of surgery. Accrual is estimated at 1.5 to 2 patients per month for 25 to 33 months, based on accrual rates for a recent pre-operative window thoracic surgical study at UHN.
Correlatives:
The following molecular and serological correlative biomarkers will be considered covariates in the analysis of primary endpoints of the phase II study. Covariate pretreatment values and changes in covariate values (where applicable) will be used to estimate the relationship between covariates and patient's Ki67 or apoptotic response using logistic regression. It is noted that several covariates are being tested and the number of patients being analyzed is small, thus, some tests may be statistically significant due to chance even if no association exists.
Genetic Mutations in NSCLC (On pre-treatment biopsies by molecular techniques):
Protein Marker of Resistance To Metformin (On pre-treatment biopsies by immunohistochemistry
VASCULARITY IN NSCLC (Comparison between pre-treatment biopsies and post-resection specimens by immunohistochemistry):
SERUM LIGANDS TO SIGNALLING PATHWAYS IN NSCLC (Comparison between pre-treatment biopsies and post-resection specimens by ELISA):
Statistics:
Patients who completed metformin treatment will have the Ki67 and apoptosis scores compared between samples obtained pre and post-metformin treatment. Changes in Ki67 and apoptotic scores with metformin treatment will be correlated with the biomarkers of various pathways hypothesized to mediate an effect of metformin on NSCLC development.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 28 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Have organ and marrow function as defined below for safe lung biopsy and administration of metformin:
Exclusion Criteria:
Not have uncontrolled intercurrent illness (es) including but not limited to: ongoing or active:
14 to 21 days of pre-operative Metformin tablets First 5 days 850 mg OD v/o 850 mg BID thereafter until 21 days are completed.
Drug: Metformin
850 mg tablets v/o OD for first 5 days 850 mg tablets v/o BID until day 21
Also known as: Glucophage
Ki67
• The difference in the proportion of proliferating NSCLC cells (measured by comparing Ki67 levels) prior to and after metformin treatment.
Time frame: 45 days after surgery
Apoptosis
• The rate of apoptosis of NSCLC (measured by the TUNEL assay) prior to and after metformin treatment.
Time frame: 45 days after surgery
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
• The safety and tolerability of preoperative metformin administration in NSCLC, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE \[version 4.0\])
Time frame: During a minimum of 14 days and maximum of 21 days patients will be assessed every 5 days during treatment and 30 days after surgery
Pathology
• Pathologic changes in lung tissue after metformin administration
Time frame: 45 days after surgery
Plan to share: Undecided
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University Health Network, Toronto