Lung CancerPhase 3CANALNCT05725343
A Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer
A Phase 3 study testing Canakinumab in people with Lung Cancer, run by Mario Negri Institute for Pharmacological Research at 6 sites in Italy.
Trial summary
Randomized phase III, double-blind, placebo-controlled, multicenter clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Canakinumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 6 sitesItaly
- Study dates
- 3 Feb 2022to 21 Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained prior to any screening procedures.
- Age ≥18 years and ≤75 years;
- PLCO risk >2,5% in 6 years to undergo CT screening;
- 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;
- CRP levels above 3 mg/L;
- Former smokers or current smokers participating in smoking-cessation-programs or subjects with incidental diagnosis of undetermined nodules;
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- Subjects must have normal organ and bone marrow function:
- Haemoglobin ≥ 10.0 g/dL.
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
- Platelet count ≥ 100 x 109/L.
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
- Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN.
Who cannot join
- Active infection;
- Subjects with previous diagnosis of invasive cancer in the 5 years before enrolment;
- 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:
- History of any of the following: residence in a congregate setting (e.g. jail or prison, homeless shelter, or chronic care facility), substance abuse (e.g. injection or noninjection) health-care workers with unprotected exposure to subjects who are at high risk of TB or subjects with TB disease before the identification and correct airborne precautions of the subject
- Close contact (i.e. share the same air space in a household or other enclosed environment for a prolonged period (days or weeks, not minutes or hours)) with a person with active pulmonary TB disease within the last 12 months.
- Evidence of TB infection (active or latent), at Visit 1, determined by purified protein derivative (PPD) skin test and/or QuantiFERON®-TB Gold (QFT-g) assay as defined by country guidelines (refer to Determination of Tuberculosis Status, p.39).
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- If presence of TB (active or latent) is established then treatment (according to country guidelines for TB treatment or TB treatment with immunomodulating drugs) must have been initiated or completed prior to randomization per country guidelines.
- In the absence of country TB (active or latent) guidelines, the following has been demonstrated: TB has been treated adequately with antibiotics, cure can be demonstrated, and risk factors resulting in TB exposure and contracting TB have been removed (e.g. the subject does not live anymore in high TB exposure setting).
- Subjects with suspected or proven immunocompromised state, including (a) those with evidence of Human Immunodeficiency Virus (HIV) infection; subjects on anti-retroviral therapy are excluded (b) those with any other medical condition which in the opinion of the investigator places the subject at unacceptable risk for participation in immunomodulatory therapy; or (c) those requiring systemic or local treatment with any immune modulating agent in doses with systemic effects e.g. high dose oral or intravenous steroids (> 20 mg prednisone orally daily for > 30 days, > 5 mg prednisone orally daily or equivalent dose of intravenous steroid) or high dose methotrexate (> 15 mg weekly). Topical, inhaled, local steroid use in doses that are not considered to cause systemic effects are permitted.
- History or current diagnosis of cardiac disease, including any of the following:
- recent myocardial infarction or coronary artery bypass graft (CABG) surgery within last 6 months,
- uncontrolled congestive heart failure,
- unstable angina (within last 6 months),
- clinically significant (symptomatic) cardiac arrhythmias.
- Known active or recurrent hepatic disorder including cirrhosis, hepatitis B and C (positive or indeterminate central laboratory results).
- Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1β inhibitor).
- Subjects who received any biologic drugs targeting the immune system at any time.
- All conditions contraindicating canakinumab according to summary of product characteristics according to EMA
- History of hypersensitivity to drugs of similar chemical classes or to canakinumab or its excipients that contraindicates the subject's participation.
- Any life-threatening condition with life expectancy < 5 years that might prevent the subject from completing the study
- Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study treatment and for up to 3 months after last dose of study drug. Basic contraception methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- Male sterilization (at least 6 months prior to screening).
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps).
- Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS). In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- Subject with nodules larger than 8 mm with Positron emission tomography (PET) SUV >2,5 for which surgical evaluation is indicated.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Ente Ospedaliero Ospedali Galliera
Genova
Ospedale San Martino
Genova
IRST Meldola
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Ospedale San Raffaele
Milan
Istituto Clinico Humanitas Rozzano
Rozzano, Milano, Italy
About this study
Official title: A Phase III Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer _ CANAL Study
Randomized phase III, double-blind, placebo-controlled, multicenter clinical trial.
Read the 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
- Being tested
- Canakinumab, Placebo
- Keywords
- Lung cancer, Prevention, Canakinumab
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
Also called ilaris
Canakinumabwill be administered up to three years, or until lung cancer diagnosis, unacceptable toxicity or physician/subject's decision to withdraw, whichever comes first.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Canakinumab | Experimental | Eligible subjects will be randomized in a 3:2 ratio to receive either canakinumab s.c. at 200 mg or placebo every two months. Receives: Drug: Canakinumab |
| Placebo | Placebo comparator | Eligible subjects will be randomized in a 3:2 ratio to receive either canakinumab s.c. at 200 mg or placebo every two months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Lung Cancer
TTLC 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.
Measured: 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
Secondary outcomes (5)
Time to Lung cancer death
Time to Lung cancer death
Measured: date of randomization, up to 48 months
Overall Survival (OS)
Overall Survival (OS)
Measured: date of randomization, up to 48 months
cancer mortality
cancer mortality
Measured: date of randomization, up to 48 months
shrinkage of non-solid nodules
shrinkage of non-solid nodules
Measured: date of randomization, up to 48 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: date of randomization, up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start3 Feb 2022
- Primary completion3 Apr 2022
- Study completion21 Sep 2022
Why it stopped: Novartis has decided to terminate the trial due to the recent results made available from the Novartis CANOPY A study (CACZ885T2301), this decision is not related to any safety data for Canakinumab
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects will be randomized in a 3:2 ratio to receive either canakinumab s.c. at 200 mg or placebo every two months.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Andrea De Censi, Principal investigator, Ospedali Galliera di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725343
- Sponsor's protocol ID
- IRFMN-LUNG-8287
- Acronym
- CANAL
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer _ CANAL Study
- ClinicalTrials.gov ID
- NCT05725343
- Acronym / sponsor ID
- CANAL / IRFMN-LUNG-8287
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Prevention, Canakinumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Novartis has decided to terminate the trial due to the recent results made available from the Novartis CANOPY A study (CACZ885T2301), this decision is not related to any safety data for Canakinumab
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 3 Apr 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Eligible subjects will be randomized in a 3:2 ratio to receive either canakinumab s.c. at 200 mg or placebo every two months.
| Arm | Type | Receives |
|---|---|---|
| Canakinumab | Experimental | Drug: CanakinumabEligible subjects will be randomized in a 3:2 ratio to receive either canakinumab s.c. at 200 mg or placebo every two months. |
| Placebo | Placebo comparator | Drug: PlaceboEligible subjects will be randomized in a 3:2 ratio to receive either canakinumab s.c. at 200 mg or placebo every two months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent must be obtained prior to any screening procedures.
- Age ≥18 years and ≤75 years;
- PLCO risk >2,5% in 6 years to undergo CT screening;
- 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;
- CRP levels above 3 mg/L;
Key exclusion criteria (27 listed)
- Active infection;
- Subjects with previous diagnosis of invasive cancer in the 5 years before enrolment;
- 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:
- Subjects with suspected or proven immunocompromised state, including (a) those with evidence of Human Immunodeficiency Virus (HIV) infection; subjects on anti-retroviral therapy are excluded (b) those with any other medical condition which in the opinion of the investigator places the subject at unacceptable risk for participation in immunomodulatory therapy; or (c) those requiring systemic or local treatment with any immune modulating agent in doses with systemic effects e.g. high dose oral or intravenous steroids (> 20 mg prednisone orally daily for > 30 days, > 5 mg prednisone orally daily or equivalent dose of intravenous steroid) or high dose methotrexate (> 15 mg weekly). Topical, inhaled, local steroid use in doses that are not considered to cause systemic effects are permitted.
- History or current diagnosis of cardiac disease, including any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanakinumabAlso: ilarisCanakinumabwill be administered up to three years, or until lung cancer diagnosis, unacceptable toxicity or physician/subject's decision to withdraw, whichever comes first. | Drug | Canakinumab |
| Placeboplacebo will 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 |
Primary outcome
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
TTLC 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.
5 secondary outcomes
Time to Lung cancer death
Time frame: date of randomization, up to 48 months
Overall Survival (OS)
Time frame: date of randomization, up to 48 months
cancer mortality
Time frame: date of randomization, up to 48 months
shrinkage of non-solid nodules
Time frame: date of randomization, up to 48 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: date of randomization, up to 48 months
Results and safety
The study was stopped early (reason given: Novartis has decided to terminate the trial due to the recent results made available from the Novartis CANOPY A study (CACZ885T2301), this decision is not related to any safety data for Canakinumab). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea De Censi principal investigator
Ospedali Galliera di Genova
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Canakinumab in people with Lung Cancer, run by Mario Negri Institute for Pharmacological Research at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Novartis has decided to terminate the trial due to the recent results made available from the Novartis CANOPY A study (CACZ885T2301), this decision is not related to any safety data for Canakinumab). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.