drugset / Trial / NCT07284485
Immunoprevention for High-risk Lung Lesions
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-05-21
- Primary completion
- 2027-12-15
- Completion
- 2029-12-17
Publications
- Background LaMarche NM, Hegde S, Park MD, Maier BB, Troncoso L, Le Berichel J, Hamon P, Belabed M, Mattiuz R, Hennequin C, Chin T, Reid AM, Reyes-Torres I, Nemeth E, Zhang R, Olson OC, Doroshow DB, Rohs NC, Gomez JE, Veluswamy R, Hall N, Venturini N, Ginhoux F, Liu Z, Buckup M, Figueiredo I, Roudko V, Miyake K, Karasuyama H, Gonzalez-Kozlova E, Gnjatic S, Passegue E, Kim-Schulze S, Brown BD, Hirsch FR, Kim BS, Marron TU, Merad M. An IL-4 signalling axis in bone marrow drives pro-tumorigenic myelopoiesis. Nature. 2024 Jan;625(7993):166-174. doi: 10.1038/s41586-023-06797-9. Epub 2023 Dec 6.
- Background Becker D, Stana J, Prendes C, Ali A, Pichlmaier M, Peterss S, Tsilimparis N. The Use of Short Dilator Tip in Endovascular Branched Arch Repair: A Case Series. J Endovasc Ther. 2026 Apr;33(2):883-890. doi: 10.1177/15266028241283713. Epub 2024 Oct 18.
- Background Ridker PM, MacFadyen JG, Thuren T, Everett BM, Libby P, Glynn RJ; CANTOS Trial Group. Effect of interleukin-1beta inhibition with canakinumab on incident lung cancer in patients with atherosclerosis: exploratory results from a randomised, double-blind, placebo-controlled trial. Lancet. 2017 Oct 21;390(10105):1833-1842. doi: 10.1016/S0140-6736(17)32247-X. Epub 2017 Aug 27.
- Background Garon EB, Lu S, Goto Y, De Marchi P, Paz-Ares L, Spigel DR, Thomas M, Yang JC, Ardizzoni A, Barlesi F, Orlov S, Yoshioka H, Mountzios G, Khanna S, Bossen C, Carbini M, Turri S, Myers A, Cho BC. Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non-Small-Cell Lung Cancer: Results From the CANOPY-A Double-Blind, Randomized Clinical Trial. J Clin Oncol. 2024 Jan 10;42(2):180-191. doi: 10.1200/JCO.23.00910. Epub 2023 Oct 3.
- Background Tan DSW, Felip E, de Castro G, Solomon BJ, Greystoke A, Cho BC, Cobo M, Kim TM, Ganguly S, Carcereny E, Paz-Ares L, Bennouna J, Garassino MC, Schenker M, Kim SW, Brase JC, Bury-Maynard D, Passos VQ, Deudon S, Dharan B, Song Y, Caparica R, Johnson BE. Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial. J Clin Oncol. 2024 Jan 10;42(2):192-204. doi: 10.1200/JCO.23.00980. Epub 2023 Dec 1.
- Background International Early Lung Cancer Action Program Investigators; Henschke CI, Yankelevitz DF, Libby DM, Pasmantier MW, Smith JP, Miettinen OS. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med. 2006 Oct 26;355(17):1763-71. doi: 10.1056/NEJMoa060476.
- Background Henschke CI, Yip R, Sun Q, Li P, Kaufman A, Samstein R, Connery C, Kohman L, Lee P, Tannous H, Yankelevitz DF, Taioli E, Rosenzweig K, Flores RM; I-ELCAP; IELCART Investigators. Prospective Cohort Study to Compare Long-Term Lung Cancer-Specific and All-Cause Survival of Clinical Early Stage (T1a-b; </=20 mm) NSCLC Treated by Stereotactic Body Radiation Therapy and Surgery. J Thorac Oncol. 2024 Mar;19(3):476-490. doi: 10.1016/j.jtho.2023.10.002. Epub 2023 Oct 6.
- Background Garlanda C, Dinarello CA, Mantovani A. The interleukin-1 family: back to the future. Immunity. 2013 Dec 12;39(6):1003-18. doi: 10.1016/j.immuni.2013.11.010.
- Background Nemoto H, Honjo M, Okamoto M, Sugimoto K, Aihara M. Potential Mechanisms of Intraocular Pressure Reduction by Micropulse Transscleral Cyclophotocoagulation in Rabbit Eyes. Invest Ophthalmol Vis Sci. 2022 Jun 1;63(6):3. doi: 10.1167/iovs.63.6.3.
- Background Baas P, Scherpereel A, Nowak AK, Fujimoto N, Peters S, Tsao AS, Mansfield AS, Popat S, Jahan T, Antonia S, Oulkhouir Y, Bautista Y, Cornelissen R, Greillier L, Grossi F, Kowalski D, Rodriguez-Cid J, Aanur P, Oukessou A, Baudelet C, Zalcman G. First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2021 Jan 30;397(10272):375-386. doi: 10.1016/S0140-6736(20)32714-8. Epub 2021 Jan 21.
- Background Focker J, Huang L, Caling AL, Fischer M, Ihle A, Hodgson T, Kattner F. Enhanced auditory serial recall of recently presented auditory digits following auditory distractor presentation in blind individuals. Q J Exp Psychol (Hove). 2024 Dec 16:17470218241300115. doi: 10.1177/17470218241300115. Online ahead of print.
- Background Krammer F. A correlate of protection for SARS-CoV-2 vaccines is urgently needed. Nat Med. 2021 Jul;27(7):1147-1148. doi: 10.1038/s41591-021-01432-4. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NIDANILIMAB | Monoclonal antibody | 10 mg/kg | Intravenous |
Indications
No indication recorded.