Last updated 18 months ago
Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations
312 patients around the world
Available in Mexico
Instituto Nacional de Cancerologia de Mexico
1Research sites
312Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.Measurable disease by RECIST 1.1.18 years of age or older.Functional status 0-2 as assessed by Eastern Cooperative Oncology Group (ECOG) scale.Life expectancy of minimum12 weeks.Patients with non-small cell lung cancer and a documented EGFR sensitizing mutation.Patients without previous EGFR-TKI treatment. Previous use of chemotherapy is allowed with a washout period of at least 6 months.Patients with asymptomatic brain metastases, or if symptoms are present treatment with radiotherapy (whole brain radiotherapy, stereotactic radiosurgery) or surgery must be administered.Neutrophil count ≥1.5 x 103/mm3, and platelet count >100 x (103/mm3).Serum bilirubin ≤1.5 the superior upper limit.Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2 superior upper limit (or ≤ 5 times the superior upper limit in patients with liver metastases).Serum creatinine ≤ 1.5 superior upper limit, or creatinine clearance ≥ 60ml/min.Full ability to complete all study procedures and follow up.Women with child-bearing potential must have a negative pregnancy test within 72 hours of treatment start.Patients with reproductive potential must use effective contraception.Signed informed consent for participation in the study.Availability of tumor tissue (pre-treatment biopsy) to determine LKB1 and AMPK status.
- Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart disease, hepatic diseases, renal diseases).Patients previously treated with an EGFR-TKI.Patients diagnosed with any other neoplastic disease in the previous 5 years (except in situ cervical carcinoma or basocellular skin cancer, treated accordingly).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.Pregnant or lactating women.Patients diagnosed with type 2 diabetes or a glycated hemoglobin ≥ 6.5%.Patients being currently treated with metformin.
Sites
Instituto Nacional de Cancerología - Ciudad de México
Recruiting
StudyMETLUNG
SponsorInstituto Nacional de Cancerologia de Mexico
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05445791
