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.
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 shows response in stage 1 the arm will be stopped for futility. And if at least two patients have a documented regression of at least one high-risk part solid nodule, without significant DLT, then prior to opening Simon's Two Stage expansion slots the researchers will submit an amendment to the FDA with updated toxicity data regarding the first 20 patients enrolled. The researchers will await FDA approval of this amendment before the researchers would start enrollment of the additional patients beyond the first 20 patients. If FDA approves then an additional 36 patients will be enrolled in stage 2. From the complete arm of 56 patients if 5 or more patients achieve a response then nadunolimab will be declared efficacious. and a larger phase 2-3 trial could be developed to more formally test the efficacy of the drug. As such, statistical comparisons will still be compared to the historical control which represents the current standard treatment of observation. The researchers anticipate accrual to take up to 2 years from the time of initiation resulting an accrual of 1-3 patient per month. The researchers expect to replace up to 5% of the patients. Hence, the total number of patients that should be enrolled to obtain the aforementioned 56 evaluable patients is 59 if study is expanded to stage 2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Nadunolimab will be administered 10mg/kg intravenously every 3 weeks for 4 doses
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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.
Time frame: 3 months from initiation of study drug
Number of adverse events
The safety and tolerability of nadunolimab will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0.
Time frame: 6 months from initiation of study drug.
Number of participants with regression of nodules
The regression of nodules defined as ≥20% reduction in the largest diameter of at least one lung nodule at 3 months after initiation of biologic therapy., at subsequent follow-up imaging timepoints past 3 months for up to 2 years
Time frame: 2 years from initiation of study drug.
Progression-free survival
Progression-free survival based on the time from treatment initiation until the time of radiographic evidence of progression of disease, initiation of anti-cancer therapy or death, whichever comes first
Time frame: From treatment initiation until progression of disease, initiation of anti-cancer therapy or death, up to 2 years, whichever comes first.
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