Ignite Creation Date:
2025-12-18 @ 8:41 AM
Ignite Modification Date:
2025-12-23 @ 8:45 PM
Study NCT ID:
NCT07284485
Status:
None
Last Update Posted:
2025-12-16 00:00:00
First Post:
2025-12-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunoprevention for High-risk Lung Lesions
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase 2 Trial of Nadunolimab for Current or Former Smokers With High-risk Lung Nodules.
Status:
None
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: