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

Sponsor
Mario Negri Institute for Pharmacological Research
Study ID
NCT05725343
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Feb 3, 2022
Status verified
Feb 2023
Primary completion
Apr 3, 2022
Completion
Sep 21, 2022

Study Design

Enrollment
350 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Canakinumab
    Eligible subjects will be randomized in a 3:2 ratio to receive either canakinumab s.c. at 200 mg or placebo every two months.
  • Placebo Comparator: Placebo
    Eligible subjects will be randomized in a 3:2 ratio to receive either canakinumab s.c. at 200 mg or placebo every two months.

Primary Outcome Measure

Time To Lung Cancer [ Time Frame: date of randomization up to the date of lung cancer or, for subjects free from disease, the date of last contact, up to 48 months ]

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