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Prevention study for High-risk Lung Nodules
Official title Immunoprevention for High-risk Lung Lesions
ClinicalTrials.gov ID: NCT07284485
What this study is testing
What is Nadunolimab?
Nadunolimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high-risk lung nodules.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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.
You likely can't join 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...
- 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...
- Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.