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Could a common diabetes pill boost lung cancer treatment?

NCT ID NCT05445791

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 312 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • Instituto Nacional de Cancerologia

    RECRUITING

    Mexico City, 14080, Mexico

    Contact Email: •••••@•••••

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