Immunoprevention for High-risk Lung Lesions

NCT07284485 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY-25-00757PRMC-25-050
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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

High-risk Lung Nodules

Keywords

High-risk Lung nodules; Nadunolimab; immunoprevention; tobacco smokers 20 pack-years; multi-focal part-solid nodules; immunomodulatory compounds

Outcome Measures

Primary Outcomes (1)

• Response rate

  Response rate is defined as the proportion of patients who achieve this regression on imaging obtained at 3 months. Regression will be defined as ≥20% reduction in the largest diameter of at least one lung nodule at 3 months after initiation of biologic therapy.

  3 months from initiation of study drug

Secondary Outcomes (3)

• Number of adverse events

  6 months from initiation of study drug.

• Number of participants with regression of nodules

  2 years from initiation of study drug.

• Progression-free survival

  From treatment initiation until progression of disease, initiation of anti-cancer therapy or death, up to 2 years, whichever comes first.

Study Arms (1)

Nadunolimab

EXPERIMENTAL

10mg/kg Nadunolimab administered every 3 weeks for 4 doses

Biological: Nadunolimab

Interventions

Nadunolimab BIOLOGICAL

Nadunolimab will be administered 10mg/kg intravenously every 3 weeks for 4 doses

Nadunolimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 18 years.
• ECOG 0-1. The exception will be Participants carrying long term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy. This must be documented in screening clinic visit note by investigator.
• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 1 month and 6 months following completion of therapy, for woman and men, respectively. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 24 consecutive months
• Ability to understand and the willingness to sign a written informed consent.
• Adequate organ and marrow function as defined below:
• Hematologic
• \- Absolute neutrophil count (ANC) ≥1,500 /mcL
• \- Platelets ≥100,000 /mcL
• \- Hemoglobin ≥9 g/dL

You may not qualify if:

• Any pulmonary nodule with a solid component \>8mm.
• Patients may not be receiving any other investigational agents at the time of enrollment.
• Uncontrolled intercurrent illness prior to starting therapy including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Exception: Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
• Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Exception: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
• Known HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with \<200 CD4+ T cells/microliter in the peripheral blood. HIV testing is not required for patients with no known history of HIV.
• Has known Hepatitis B or active Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). HBV and HCV testing is not required for patients with no known history of these viruses.
• History of allogeneic hematopoietic cell transplantation or solid organ transplantation.
• Receipt of a live vaccine, etanercept, or tumor necrosis factor-alpha inhibitors within 30 days of planned start of study drug
• Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps)Principal investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient.

Sponsors & Collaborators

• Robert Samstein: lead
• Cantargia AB: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Related Publications (12)

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Study Officials

• Robert M Samstein, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Thomas Marron, MD, PhD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

Central Study Contacts

Lisa Fitzgerald

CONTACT

(917) 748-0962; lisa.fitzgerald@mssm.edu

Rashmi Unawane

CONTACT

(212) 824-2385; rashmi.unawane@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 16, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 17, 2029
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)