RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III, SUPERIORITY TRIAL TO ASSESS THE EFFICACY AND SAFETY OF ACETYL-L-CARNITINE IN COMBINATION WITH A CISPLATIN CONTAINING CHEMOTHERAPY AS FIRST LINE TREATMENT OF ADVANCED OR METASTATIC NON SMALL CELL LUNG CANCER - ND

• Conditions: Patients with histologically documented, locally advanced (stage IIIB with either pleural effusion or supra-clavicular nodal disease) or metastatic (stage IV) or recurred after an adjuvant treatment NSCLC.; MedDRA version: 9.1Level: LLTClassification code 10059515; MedDRA version: 9.1Level: PTClassification code 10029521

• Registration Number: EUCTR2010-022021-15-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-08
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

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