Actively Recruiting
Immunoprevention for High-risk Lung Lesions
Led by Robert Samstein · Updated on 2026-03-10
59
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
R
Robert Samstein
Lead Sponsor
C
Cantargia AB
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of this study is to assess nadunolimab as an immunoprevention strategy for high-risk lung nodules in participants who are current or former tobacco smokers. The study may last up to 5 years for each participant.
CONDITIONS
Official Title
Immunoprevention for High-risk Lung Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be current or former tobacco smokers (>20 pack years)
- Participants must have multi-focal part-solid nodules (>2 lesions, at least one with solid component <9mm) with evidence of progression on at least one annual follow-up CT scan.
- Participants must not meet criteria for surgical intervention at the time of enrollment.
- Patient must be willing and able to provide blood samples (12 green-top tubes, roughly 100mL) at the five time points indicated in the Study Calendar.
- Age 218 years.
- ECOG performance status 0-1, except for participants with documented long term disabilities that are not acute or progressive.
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during study participation, and for specified periods after therapy.
- Ability to understand and willingness to sign informed consent.
- Adequate organ and marrow function as defined by specific hematologic, renal, and hepatic laboratory criteria.
You will not qualify if you...
- Any pulmonary nodule with a solid component >8mm.
- Patients receiving other investigational agents at enrollment.
- Uncontrolled illnesses including active infections requiring antibiotics (except brief course completed before treatment), symptomatic heart failure, unstable angina, or psychiatric illness/social issues limiting compliance.
- Pregnant or nursing women.
- Diagnosis of immunodeficiency or recent systemic steroid or immunosuppressive therapy (with exceptions for stable low-dose chronic steroids).
- Active autoimmune disease requiring systemic treatment in past year (with exceptions for replacement therapies).
- Conditions, therapies, or lab abnormalities that may interfere with trial participation or results.
- Known HIV with detectable viral load or unstable treatment status.
- Known active Hepatitis B or C infection.
- History of allogeneic stem cell or solid organ transplantation.
- Receipt of live vaccines or certain immunomodulatory drugs within 30 days before study drug.
- Allergic or hypersensitivity reactions to protein therapeutics.
- Investigator judgment that patient cannot comply or that participation is not in patient's best interest.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
L
Lisa Fitzgerald
CONTACT
R
Rashmi Unawane
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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