Immunoprevention for High-risk Lung Lesions

Part of paid clinical trials in New York, New York.

Sponsor: Robert Samstein
Study ID: NCT07284485
Phase: PHASE2
Status: Recruiting

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Conditions

High-risk Lung Nodules

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Nadunolimab — BIOLOGICAL
Nadunolimab will be administered 10mg/kg intravenously every 3 weeks for 4 doses

Study Details

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.

Key Dates

Start date: May 21, 2026
Status verified: Jun 2026
Primary completion: Dec 15, 2027
Completion: Dec 17, 2029

Study Design

Enrollment: 59 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Nadunolimab
10mg/kg Nadunolimab administered every 3 weeks for 4 doses

Primary Outcome Measure

Response rate [ Time Frame: 3 months from initiation of study drug ]

Central Contacts

Lisa Fitzgerald
(917) 748-0962
[email protected]
Rashmi Unawane
(212) 824-2385
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Icahn School of Medicine at Mount Sinai	New York	New York	10029	Lisa Fitzgerald [email protected] (917) 748-0962 Rashmi Unawane [email protected] 212-824-2385 Robert Samstein (PRINCIPAL_INVESTIGATOR)

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Icahn School of Medicine at Mount Sinai· New York, NY