Acetyl-L-carnitine in Combination With a Cisplatin-containing Chemotherapy as First Line Treatment of Advanced or Metastatic Non Small Cell Lung Cancer

Inclusion criteria: * Male or female \>= 18 * No previous CHT or targeted therapies. Previous adjuvant or neo-adjuvant treatment is permitted if completed ≥ 6 months before study inclusion. * ECOG performance status 0-1 * Adequate organ functions defined as follows: * Neutrophils \>= 1.5 x 109/L, platelets \>= 100 x 109/L, and hemoglobin \>= 9 g/dL * Bilirubin level either normal or \< 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 * Written informed consent given before the randomization, according to International Conference on Harmonization/Good Clinical Practice (ICH/GCP) Exclusion criteria: * Symptomatic brain metastases * Any investigational agent(s) within 4 weeks prior to study entry * Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months * Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease * Patients with known allergy to any other components of the study drugs * History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complication * Known drug abuse/ alcohol abuse * 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 * Clinically relevant peripheral neuropathy * 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) * Pregnancy or breast feeding. Women of childbearing potential and their parents must be willing to practice acceptable methods of birth control to prevent pregnancy * Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule