Immunoprevention for High-risk Lung Lesions (NCT07284485) | Clinical Trial Compass
RecruitingPhase 2
Immunoprevention for High-risk Lung Lesions
United States59 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 p…