A Phase 2 Trial of Nadunolimab for Current or Former Smokers With High-risk Lung Nodules.
Robert Samstein
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.
Description
The trial is a single-arm phase 2 of trial nadunolimab as an immunoprevention strategy for high-risk lung nodules. Eligible patients include patients who currently smoke or have previously smoked more than 20 pack-years and have high-risk lung nodules. High-risk nodules are defined as multifocal part-solid nodules (\> or equal to 2 lesions, at least one with solid component \<9mm) with evidence of progression on at least one annual follow-up CT scan. The trial will be run as a Simon's optimal two-stage design, with an initial enrollment of 20 patients in the first stage. If only one patient s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalNadunolimab
Nadunolimab will be administered 10mg/kg intravenously every 3 weeks for 4 doses
Location
- Icahn School of Medicine at Mount SinaiNew York, New York