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Cigarette Smoking-Related CarcinomaPhase 2NCT06038526

Evaluation of Canakinumab in High-Risk Former-Smokers

A Phase 2 study testing Biospecimen Collection, Bronchoscopy and Canakinumab in people with Cigarette Smoking-Related Carcinoma and Lung Carcinoma, run by Peter Shields at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial tests the impact of canakinumab on biologic samples (buccal, nasal, and blood) from former smokers with increased risk of cancer. Canakinumab blocks the activity of a protein called interleukin-1 beta (IL-1b), an agent of the inflammatory system and is used for the treatment of different non-cancer… Read more about this study

Who is it for?
Ages 40 to 73 yearsHealthy volunteers can take part
What is being tested?
Biospecimen Collection, Bronchoscopy and Canakinumab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
11 Mar 2024to 26 May 2026
Phase
Phase 2
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 40 to 73 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Smoked tobacco or cannabis within 3 years of enrollment (target study population is former smokers) Used an electronic cigarette or vaped including THC within 3 years of enrollment (impacts biomarkers)3 CO > 8ppm (target study population is former smokers) History of or recent exposure to tuberculosis (TB) as documented in the EMR and/or testing (impacts risk) BMI > 45 (risk of unstable airway)
  • Taking ASA or NSAIDs daily or most days per week (impacts biomarkers and risk)
  • Concomitant diseases and life-threatening conditions (e.g., cancer or kidney, liver, immune system disorders)
  • Prior diagnosis of chronic pulmonary disease that requires regular use of inhalers or medications that influence biomarkers (e.g., asthma, chronic bronchitis, and restrictive lung disease) (impacts biomarkers and risk)
  • Acute bronchitis or pneumonia within 1 year (impacts biomarkers)
  • COVID-19 diagnosis or related symptoms within the last 3 months (impacts biomarkers and risk)
Show all 30Show fewer
  • General anesthesia within 3 months (impacts biomarkers)
  • Regular use of inhalant medications in the last 3 months (impacts biomarkers)
  • Use of antibiotics in prior 30 days (impacts biomarkers)
  • Use of steroids, including corticosteroids and inhaled corticosteroids, in prior 30 days (impacts biomarkers)
  • Use of prohibited concomitant therapy including but not limited to immunosuppressants (impacts biomarkers and risk)4
  • Live or attenuated vaccines within 90 days of study treatment and after initiation of study drug (impacts biomarkers and risk)5
  • Allergies to study medications, such as, lidocaine, Versed, Fentanyl or Cetacaine (impacts risk)
  • Bronchoscopy or any other lung procedure for any reason within the previous 6 months (impacts biomarkers)
  • Current or recent (within three months) alcohol or drug abuse problems (impacts risk)
  • Unable to read for comprehension or completion of study documents (impacts risk)
  • 1Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 6 weeks after stopping medication. Highly effective contraception methods include:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant
  • Use of oral, (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. 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.
  • Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms). Women are considered not of a childbearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential.
  • Women will also be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women ≥50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
  • 2According to institutional standards, which may evolve throughout the study, if a subject self-reports testing positive for COVID-19, the condition should be resolved without ongoing symptoms for at least three months. If a subject tests positive before the first bronchoscopy, the subject would be placed on a wait list for at least three months and re-tested before his/her appointment; if a subject tests positive before a follow-up bronchoscopy, his/her participation will be withdrawn by the PI.
  • 3Smoking or vaping any form of tobacco product or cannabis/THC is an exclusion; however, other use of THC administration (e.g., edible, topical, etc.) are permitted.
  • 4Prohibited concomitant therapy:
  • Immunosuppressants Use of any treatments below is NOT allowed after the start of study treatment due to potential increase in immunosuppressant related concomitant conditions. They are prohibited for the duration of the study and for at least 130 days after discontinuation of study treatment. If a subject chooses to continue one of the medications below, they will be followed.
  • Anti-retro-viral and / or biologic drugs targeting the immune system (e.g., TNF blockers, anakinra, rituximab, abatacept, tocilizumab) Immune modulating agent in doses with systemic effects including but not limited to Prednisone >20 mg (or equivalent) oral or intravenous daily for >14 days; Prednisone > 5 mg and ≤ 20 mg (or equivalent) daily for > 30 days; Equivalent dose of methotrexate >15 mg weekly. Cytochrome P450 Substrates - The formation of CYP450 enzymes is suppressed by increased levels of cytokines (e.g., IL-1) during chronic inflammation. Thus, it is expected that for a molecule that binds to IL-1, such as canakinumab, the formation of CYP450 enzymes could be normalized. This is clinically relevant for CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g., warfarin). Upon initiation of canakinumab, in patients being treated with these types of medicinal products, therapeutic monitoring of the effect or drug concentration should be performed and the individual dose of the medicinal product may need to be adjusted as needed. Ilaris USPI 2020 - 7.3 - https://www.novartis.com/us-en/sites/novartisus/files/ilaris.pdf
  • 5Subjects must be discontinued from the trial if administered any live or attenuated vaccine during the course of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Molecular Studies of Canakinumab in High-Risk Former-Smokers (CANIFS)

This phase II trial tests the impact of canakinumab on biologic samples (buccal, nasal, and blood) from former smokers with increased risk of cancer. Canakinumab blocks the activity of a protein called interleukin-1 beta (IL-1b), an agent of the inflammatory system and is used for the treatment of different non-cancer diseases (like auto-inflammatory diseases). Giving canakinumab may block the inflammatory system and could have positive effects to reduce cancer growth.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare baseline bronchoscopy biospecimens with samples approximately 70 days after administration of canakinumab (2 doses, approximately 14 days apart) in healthy former smokers.

SECONDARY OBJECTIVE:

  1. Determine the impact of IL-1beta inhibition on downstream inflammatory pathways.

OUTLINE:

Patients undergo bronchoscopy over 30-60 minutes on day 7 and receive canakinumab subcutaneously (SC) 60 minutes and 2 weeks after the initial bronchoscopy. Patients undergo an additional bronchoscopy on day 77. Patients undergo buccal, nasal, and blood sample collection and carbon monoxide (CO testing on study).

Being tested
Biospecimen Collection, Bronchoscopy, Canakinumab, Carbon Monoxide Measurement, Survey Administration
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo buccal, nasal, and blood sample collection

  • BronchoscopyProcedure or surgery

    Undergo bronchoscopy

  • CanakinumabBiological

    Also called ACZ885, Ilaris

    Given SC

  • Carbon Monoxide MeasurementProcedure or surgery

    Also called Carbon Monoxide, CO

    Undergo CO testing

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT06038526
Study groupRoleWhat they receive
Prevention (canakinumab, bronchoscopy)ExperimentalPatients undergo bronchoscopy over 30-60 minutes and receive canakinumab SC 60 minutes and 2 weeks after the initial bronchoscopy. Patients undergo an additional bronchoscopy on day 77. Patients undergo buccal, nasal, and blood sample collection and CO testing on study.
Receives: Procedure: Biospecimen Collection; Procedure: Bronchoscopy; Biological: Canakinumab; Procedure: Carbon Monoxide Measurement; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in ASCs (apoptosis-associated speck-like protein containing a caspase activation and recruitment domain)

    Will be assessed by a generalized linear mixed model (GLM) and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.

    Measured: At baseline and day 77

  2. Change in caspase-1

    Will be assessed by a GLM and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.

    Measured: At baseline and day 77

  3. Change in interleukin-1 beta (IL-1beta)

    Will be assessed by a GLM and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.

    Measured: At baseline and day 77

Secondary outcomes (4)

  1. Changes in immune cell composition in bronchoalveolar lavage (BAL) by mass cytometry (CyTOF)

    Will be performed using SPADE to create a global map of cell types present across samples and how the frequency or activation state of each cell type differs between baseline vs. follow-up (single arm). Will assess batch effects and include batch as a co-variable in the models. Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by ribonucleic acid sequence (RNASeq).

    Measured: At baseline and day 77

  2. Changes in cytokines in the blood

    Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by RNASeq.

    Measured: At baseline and day 77

  3. Changes in BAL

    Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by RNASeq.

    Measured: At baseline and day 77

  4. Bronchoscopy for fractional concentration of exhaled nitric oxide (FeNO)

    Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by RNASeq.

    Measured: At baseline and day 77

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2023
  2. Study start11 Mar 2024
  3. Primary completion4 Feb 2026
  4. Study completion26 May 2026

Resources

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06038526
Sponsor's protocol ID
OSU-22297
Other IDs
NCI-2023-05942
Status last verified
Jul 2026
First submitted
6 Sep 2023
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Bronchoscopy and Canakinumab in people with Cigarette Smoking-Related Carcinoma and Lung Carcinoma, run by Peter Shields at 1 site in United States.

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 0 inclusion and 30 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in ASCs (apoptosis-associated speck-like protein containing a caspase activation and recruitment domain) (time frame: At baseline and day 77). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06038526.

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 7 Jul 2026.

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