NCT05725343

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Canakinumab	Canakinumabwill be administered up to three years, or until lung cancer diagnosis, unacceptable toxicity or physician/subject's decision to withdraw, whichever comes first.
DRUG	Placebo	placebo will be administered up to three years, or until lung cancer diagnosis, unacceptable toxicity or physician/subject's decision to withdraw, whichever comes first.

Timeline

• Start date: 2022-02-03
• Primary completion: 2022-04-03
• Completion: 2022-09-21
• First posted: 2023-02-13
• Last updated: 2023-02-13

Locations

6 sites across 1 country: Italy