Metformin Plus TKI Use in Patients With Non-Small Cell Lung Carcinoma
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ClinicalTrials.gov Identifier: NCT03071705 |
Recruitment Status : Unknown
Verified March 2017 by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico.
Recruitment status was: Recruiting
First Posted : March 7, 2017
Last Update Posted : March 7, 2017
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Treatment for patients with mutation in the epidermal growth factor receptor (EGFR) with specific domain tyrosine kinase inhibitors (TKIs) has given place to objective clinical response, increase in progression-free survival (PFS) compared to cytotoxic chemotherapy. However, despite clinical success with different TKIs, most patients eventually develop acquired resistance to these agents after an average period of time of 10 months.
Recently metformin, an oral hypoglycemic agent, has been associated with reduction in the global risk of incidence and mortality of different types of cancer, by exercising anti-tumor properties. Its role as a chemo-preventive and adjuvant drug in overcoming acquired resistance to chemotherapy, target therapy and immunotherapy in NSCLC is still under discussion.
However, preclinical data support the role as an adjuvant drug in the treatment of NSCLC in combination with chemotherapy or EGFR-TKIs. This evidence led to examine the effects of metformin in combination with EGFR-TKIs in a NSCLC cellular line panel, obtaining a different sensibility to the unique use with EGFR-TKIs. The combination of metformin and TKIs reduced the colony forming capacity and proliferation, and induced a huge pro-apoptotic effect in NSCLC cellular lines and resistance in EGFR-TKIs. This suggests that metformin may reduce the resistance to TKIs. A retrospective study in patients from our institution from 2008 to 2014, showed significant clinical benefit in patients who used metformin, improving the global survival. Based on these considerations, we propose a phase II randomized study to assess the effect and safety of metformin in combination with TKIs as second line therapy in patients with NSCLC in advanced stages with EGFR mutation.
The main objective of this study is to assess the progression-free survival period in patients with advanced non-small cell lung cancer in treatment with TKIs and metformin versus TKI alone.
Condition or disease | Intervention/treatment | Phase |
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Non-Small Cell Adenocarcinoma Tyrosine Kinase Mutation EGFR Gene Mutation | Drug: Metformin Drug: TKI | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Other |
Official Title: | Effect of Metformin in Combination With Tyrosine Kinase Inhibitors (TKI) on Clinical, Biochemical and Nutritional in Patients With Non-Small Cell Lung Carcinoma (NSCLC): Randomized Clinical Trial |
Study Start Date : | March 2016 |
Estimated Primary Completion Date : | April 2017 |
Estimated Study Completion Date : | December 2017 |
Arm | Intervention/treatment |
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Experimental: Intervention
TKI plus Metformin
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Drug: Metformin
500 mg PO BID
Other Name: DABEXR Drug: TKI standard dose
Other Names:
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Active Comparator: Control
TKI
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Drug: TKI
standard dose
Other Names:
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- Overall Survival [ Time Frame: Start of treatment until 1-year follow-up ]
- Response Rate [ Time Frame: 3 month evaluation after start of treatment ]Inflammatory markers (IL-6, IL-12, TNF-alpha)
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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- NSCLC EGFR mutation-positive
- Use of only Metformin as oral hypoglucemic agent
- ECOG-PS 0-2
- Measurable disease
- Life expectancy >12 weeks
Exclusion Criteria:
- Systemic disease
- Patients with TKI treatment longer than 2 months
- History of other neoplasm in the past 5 years
- Breastfeeding women
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071705
Contact: Oscar Arrieta, MD, MSc | 01 55 5628 0400 ext 71100 | ogar@servidor.unam.mx |
Mexico | |
Instituto National de Cancerologia | Recruiting |
Mexico, Mexico, 14080 | |
Contact: Oscar Gerardo MD Arrieta, Oncology 015556280400 ext 71101 ogar@servidor.unam.mx |
Study Director: | Oscar Arrieta, MD, MSc | Instituto Nacional de Cancerología |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Oscar Gerardo Arrieta Rodríguez MD, Head Thoracic Oncology Unit, Instituto Nacional de Cancerologia de Mexico |
ClinicalTrials.gov Identifier: | NCT03071705 |
Other Study ID Numbers: |
016/018/ICI Ethics Committe ( Other Identifier: CEI/1019/16 ) |
First Posted: | March 7, 2017 Key Record Dates |
Last Update Posted: | March 7, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Data will be uploaded to a repository in an anonimized manner to preserve patient confidentiality. |
NSCLC metformin metformin plus TKI EGFR positive status |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Metformin Gefitinib Afatinib Hypoglycemic Agents Physiological Effects of Drugs Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |