METAL trial: metformin plus erlotinib in patients with metastatic lung cancer in second line therapy

Conditions: Patients with metastatic non small cell lung cancer in second line therapy
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-000349-59-IT

Lead Sponsor: department of experimental and clinical medicine F. Magrassi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

•Signed written informed consents
•Patients be age >18 years
•Patients must have histologically or cytologically confirmed non small cell carcinoma of the lung and are previously treated
•Patient must have measurable stage IV disease (includes M1a, M1b stages or recurrent disease) (according to the 7th edition of the TNM classification system).
•Patients must have a Life Expectancy of greater than 12 weeks.
•Patients must have an ECOG performance status 0 or 1 (Karnofsky> 70%).
•Patients must have normal organ and marrow function as defined below, within one week prior to randomization:
-Neutrophils> 1.5 x 109/L, platelets > 100 x 109/L, and hemoglobin >9 g/dL
-Bilirubin level either normalor <1.5 x ULN
-ASAT and ALAT <2.5 x ULN (< 5 x ULN if liver metastasis are present)
-Serum creatinine < 1.5 x ULN
-Alkaline phosphatase < 4 x ULN

•O2 saturation >93%.
•Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
•Patients must have the ability to understand and the willingness to sign a written informed consent document.

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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with EGFR/ALK mutated histologically proven NSCLC
•Type 1 or 2 Diabetes
•Patients with uncontrolled undercurrents illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
•Patients receiving immunotherapy, hormonal-therapy and or radiotherapy within 2 weeks prior to entering the study. Note: Those who have not recovered from adverse events due to these agents administered will be considered ineligible.
•Patients with uncontrolled brain metastasis. Note: Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks, and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
•Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin or other agents used in the study are excluded.
•Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
•Any investigational agent(s) within 4 weeks prior to entry
•Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy
•Legal incapacity or limited legal capacity
•Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
•Women who are pregnant or breastfeeding
•Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ? 5 years will be allowed to enter the trial)