Could a common diabetes pill boost lung cancer treatment?
NCT ID NCT05445791
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether adding metformin, a standard diabetes drug, to standard targeted therapy (tyrosine kinase inhibitors) can help people with advanced EGFR-mutant non-small cell lung cancer live longer without their cancer growing. About 312 participants will receive either metformin or a placebo alongside their targeted therapy. The goal is to see if this combination delays resistance to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin (a diabetes drug) plus a tyrosine kinase inhibitor (targeted cancer pill)
- What this could lead to
- If it works, this could extend the time that lung cancer stays under control for people with EGFR mutations, delaying disease progression.
- What could go wrong
- This is a mid-stage trial; earlier studies gave mixed results. Metformin may cause gastrointestinal side effects, and the benefit may be small or absent.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 312 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with a histologically confirmed diagnosis of non-small cell lung cancer (stage IIIB-IV) according to the American Joint Committee on Cancer (AJCC) eight edition. 2. Measurable disease by RECIST 1.1. 3. 18 years of age or older. 4. Functional status 0-2 as assessed by Eastern Cooperative Oncology Group (ECOG) scale. 5. Life expectancy of minimum12 weeks. 6. Patients with non-small cell lung cancer and a documented EGFR sensitizing mutation. 7. Patients without previous EGFR-TKI treatment. Previous use of chemotherapy is allowed with a washout period of at least 6 months. 8. Patients with asymptomatic brain metastases, or if symptoms are present treatment with radiotherapy (whole brain radiotherapy, stereotactic radiosurgery) or surgery must be administered. 9. Neutrophil count ≥1.5 x 103/mm3, and platelet count \>100 x (103/mm3). 10. Serum bilirubin ≤1.5 the superior upper limit. 11. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2 superior upper limit (or ≤ 5 times the superior upper limit in patients with liver metastases). 12. Serum creatinine ≤ 1.5 superior upper limit, or creatinine clearance ≥ 60ml/min. 13. Full ability to complete all study procedures and follow up. 14. Women with child-bearing potential must have a negative pregnancy test within 72 hours of treatment start. 15. Patients with reproductive potential must use effective contraception. 16. Signed informed consent for participation in the study. 17. Availability of tumor tissue (pre-treatment biopsy) to determine LKB1 and AMPK status. Exclusion Criteria: 1. Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart disease, hepatic diseases, renal diseases). 2. Patients previously treated with an EGFR-TKI. 3. Patients diagnosed with any other neoplastic disease in the previous 5 years (except in situ cervical carcinoma or basocellular skin cancer, treated accordingly). 4. Patients unable to receive oral medication, who require IV nourishment, or who underwent surgical procedures with affect nutrient absorption, or with an active peptic ulcer. 5. Pregnant or lactating women. 6. Patients diagnosed with type 2 diabetes or a glycated hemoglobin ≥ 6.5%. 7. Patients being currently treated with metformin.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Instituto Nacional de Cancerologia
RECRUITINGMexico City, 14080, Mexico
Contact Email: •••••@•••••
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