Subjects at high risk for lung cancer MedDRA version: 20.0 Level: PT Classification code 10058467 Term: Lung neoplasm malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10078411 Term: Primary prevention System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Canakinumab
Product Name: Canakinumab
Product Code: [ACZ885]
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: canakinumab
Current Sponsor code: NA
Con
Sponsors
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained prior to any screening procedures. 2. Age =18 years and =75 years; 3. PLCO risk >2,5% in 6 years to undergo CT screening; 4. Annual risk of lung cancer =3% ( 6% at 2 years or 12% at 4 years) after the baseline CT using a second risk model which includes the presence of lung nodules such as the Brock University model [13,14]; 5. CRP levels above 3 mg/L; 6. Former smokers or current smokers participating in smoking-cessation-programs or subjects with incidental diagnosis of undetermined nodules; 7. Subjects must have normal organ and bone marrow function: a. Haemoglobin = 10.0 g/dL. b. Absolute neutrophil count (ANC) = 1.5 x 109/L. c. Platelet count = 100 x 109/L. d. Total bilirubin = 1.5 x institutional upper limit of normal (ULN). e. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) = 2.5 x ULN. 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 350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 349
Exclusion criteria
Exclusion criteria: 1. Active infection; 2. Subjects with previous diagnosis of invasive cancer in the 5 years before enrolment; 3. History or evidence of tuberculosis (TB) (active or latent) infection or one of the risk factors for tuberculosis such as but not limited or exclusive to: 4. subjects with suspected or proven immunocompromised state, including (a) those with evidence of Human Immunodeficiency Virus (HIV) infection 5. History or current diagnosis of cardiac disease 6. Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results). 7. Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1ß inhibitor). 8. Subjects who received any biologic drugs targeting the immune system at any time. 9. all conditions contraindicating canakinumab according to summary of product characteristics according to EMA 10. History of hypersensitivity to drugs of similar chemical classes or to canakinumab or its excipients that contraindicates the subject’s participation. 11. Any life-threatening condition with life expectancy 2,5 for which surgical evaluation is indicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the superiority of canakinumab over placebo in terms of lung cancer incidence (LCI) in subjects at high risk for lung cancer;Secondary Objective: - Time to Lung cancer death, - Overall Survival (OS), - cancer mortality - shrinkage of non-solid nodules, - safety profile of canakinumab - Treatment compliance;Primary end point(s): The primary endpoint is the Time To Lung Cancer TTLC, that will be measured from the date of randomization up to the date of lung cancer or, for subjects free from disease, the date of last contact.;Timepoint(s) of evaluation of this end point: The endpoint will be measured from the date of randomization up to the date of lung cancer or, for subjects free from disease, the date of last contact. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: From the randomization date to the study conclusion date; From the randomization date and up to 130 days from the last administration of drug/placebo; From the first cycle to the last administration; from the date of randomization up to the date of lung cancer diagnosis to death for lung cancer; from the randomization date to death; From date og tumor diagnosi to death;Secondary end point(s): shrinkage dei noduli non solidi; safety profile of canakinumab; Treatment compliance; Time to Lung cancer death; Overall survival; cancer mortality | — |
Countries
Italy
Contacts
Public ContactLaboratorio Metodologia per la Rice
istituto di Ricerche Farmacologiche Mario Negri IRCCS
Outcome results
None listed