Can a biologic drug stop lung nodules from becoming cancer?
NCT ID NCT07284485
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a biologic drug called nadunolimab in current or former smokers who have high-risk lung nodules that are not yet ready for surgery. The goal is to see if the drug can shrink these nodules by at least 20% within 3 months, potentially preventing lung cancer. About 59 participants will receive four doses of the drug intravenously over 12 weeks and be followed for up to 5 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nadunolimab (a biologic drug given intravenously)
- What this could lead to
- If it works, this could point toward a way to prevent lung cancer in high-risk smokers by shrinking suspicious lung nodules.
- What could go wrong
- This is a small, early-phase trial with only 59 participants, so results may not apply to everyone. The drug may cause side effects or fail to shrink nodules.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 59 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * Renal\* * \- Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated (calculated per institutional standard) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min GFR for patient with creatinine levels \> 1.5 X institutional ULN * Hepatic\* * \- Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for * \- Participants with total bilirubin levels \> 1.5 ULN * \- AST or ALT ≤ 2.5 X ULN * \- Albumin \>2.5 mg/dL * If laboratory criteria are not met due to what the investigator determines to be a biologic cause (e.g. Gilbert's syndrome causing elevated bilirubin or excessive muscle mass affecting creatinine) or drug-related cause (e.g. elevating in transaminases due to HAART therapy, elevated INR due to anticoagulation) then the specific lab values will not be used to exclude patient from this trial. This determination will be made by PI. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States