Spots Global Cancer Trial Database for A Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer

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Trial Identification

Brief Title: A Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer

Official Title: A Phase III Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer _ CANAL Study

Study ID: NCT05725343

Conditions

Lung Cancer

Interventions

Canakinumab

Placebo

Study Description

Brief Summary: Randomized phase III, double-blind, placebo-controlled, multicenter clinical trial.

Detailed Description: This is a multicentre, randomized, stratified, double-blind, placebo controlled, phase III study in subjects at high risk of lung cancer with hs CRP\>3 mg/L undergoing annual screening low dose CT. The Sponsor anticipate to screen some 6.000 subjects, of whom about 700 will be recruited and evaluated in the randomized phase 3 trial. Eligible subjects will be randomized in a 3:2 ratio to receive either canakinumab s.c. at 200 mg or placebo every two months.