Stage III non-small cell lung cancer MedDRA version: 20.0 Level: LLT Classification code 10025052 Term: Lung cancer non-small cell stage III System Organ Class: 100000004864
Conditions
Interventions
Pharmaceutical Form: Coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 500-1000
Sponsors
Antwerp University Hospital, Department Thoracic Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Ability to take oral medication and willing to adhere to the RADFORMIN-regimen. 4. Male or female, = 18 years of age. 5. Histological or cytological proven stage III NSCLC after adequate staging with at least FDG-PET-CT scan, contrast enhanced CT-thorax and contrast-enhanced CT/MRI brain. 6. Absence of diabetes, (diabetes is defined as fasting plasma glucose >126 mg/dL or random plasma glucose >200 mg/dL). 7. Eastern Cooperative Oncology Group (ECOG) performance score (=WHO score) of 0-1. 8. Adequate hematologic, hepatic and renal function as follows: a. Bone Marrow: Absolute neutrophil count ANC = 1,500/mm3 (1.5 x 109/L); White blood cells = 3,000/mm3 (3 x 109/L); Platelets = 100,000/mm3 (100 x 109/L); Haemoglobin = 9 g/dL (5.58 mmol/L). b. Renal function: creatinine clearance of =50 mL/min. c. Hepatic function: i. AST and ALT = 2.5 x ULN ii. Bilirubin: =1.5 x ULN; for subjects with Gilbert’s syndrome bilirubin > 1.5 x ULN is allowed if no symptoms of compromised liver function are present 9. Adequate pulmonary function in order to be administered definitive radiotherapy. With Forced Expiratory Volume (FEV) > 1.2 litres per second or more than 50% of predicted, and DLCO > 40% predicted. (Values without administration of medical bronchodilation. In case of Tiffeneau =65 years) yes F.1.3.1 Number of subjects for this age range 63
Exclusion criteria
Exclusion criteria: 1. Current use of metformin, insulin or other oral antidiabetic drugs (thiazolidinediones, sulfonylureas, metiglinides, alpha-glucosidase inhibitors, incretin mimitics, dipaptidyl peptidase-4 inhibitors, amylin analogues, SGLT-2-inhibitors) for any reason. 2. Evidence for metastatic disease. 3. Conditions associated with increased risk of metformin-associated lactic acidosis: New York Heart Association class III or IV congestive heart failure, history of acidosis of any type, known kidney injury or disease, alcoholic liver disease or habitual intake of 3 or more alcoholic beverages per day. 4. Known pregnancy or lactating female patients. 5. Known allergic reactions to components of metformin. 6. Prior invasive malignancy within the past year (in remission, without evidence for current active disease and without maintenance therapy). Except non-melanomatous skin cancer, non-invasive carcinoma in-situ of the breast, oral cavity or cervix. 7. Known acquired immune deficiency syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study the effect of metformin when added to definitive locoregional radiotherapy on locoregional control and relapse rate in stage III non-small cell lung cancer (NSCLC) patients receiving sequential chemoradiotherapy;Secondary Objective: Identify subsets of patients who derive maximum benefit of adding metformin to radiotherapy using innovative biomarkers;Primary end point(s): Proportion of patients free of locoregional progression after 1 year. (LPFS);Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS) Time-to-progression (TPS) Progression-free survival (PFS) Best response;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Belgium
Contacts
Public ContactSecretariaat Thoraxoncologie
Antwerp University Hospital, Department Thoracic Oncology
Outcome results
None listed