A study to investigate the effect of addition of metformin to standard treatment in patients with inoperable stage III non-small cell lung cancer.

Phase 1

• Conditions: Stage III non-small cell lung cancer; MedDRA version: 20.0Level: LLTClassification code 10025052Term: Lung cancer non-small cell stage IIISystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004877-15-BE
• Lead Sponsor: Antwerp University Hospital, Department Thoracic Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-19
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 104

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 < 70% bronchodilation will be administered)
10. Having received at least 2 cycles of platinum-based chemotherapy. This according to institutional standards and without progression (on a restaging CT-scan within 3 weeks after day 1 of the last given cycle, according to RECIST criteria).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 63

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified