Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
59 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-12-15
Study Completion Date
2029-12-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
High-risk Lung Nodules
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nadunolimab
10mg/kg Nadunolimab administered every 3 weeks for 4 doses
Group Type
EXPERIMENTAL
Nadunolimab
Intervention Type
BIOLOGICAL
Nadunolimab will be administered 10mg/kg intravenously every 3 weeks for 4 doses
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nadunolimab
Nadunolimab will be administered 10mg/kg intravenously every 3 weeks for 4 doses
Intervention Type
BIOLOGICAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 postmenopausal for at least 24 consecutive months
* Ability to understand and the willingness to sign a written informed consent.
* Adequate organ and marrow function as defined below:
* Hematologic
* \- Absolute neutrophil count (ANC) ≥1,500 /mcL
* \- Platelets ≥100,000 /mcL
* \- Hemoglobin ≥9 g/dL
* Renal\*
* \- Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated (calculated per institutional standard) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min GFR for patient with creatinine levels \> 1.5 X institutional ULN
* Hepatic\*
* \- Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for
* \- Participants with total bilirubin levels \> 1.5 ULN
* \- AST or ALT ≤ 2.5 X ULN
* \- Albumin \>2.5 mg/dL
* If laboratory criteria are not met due to what the investigator determines to be a biologic cause (e.g. Gilbert's syndrome causing elevated bilirubin or excessive muscle mass affecting creatinine) or drug-related cause (e.g. elevating in transaminases due to HAART therapy, elevated INR due to anticoagulation) then the specific lab values will not be used to exclude patient from this trial. This determination will be made by PI.
* 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 postmenopausal for at least 24 consecutive months
* Ability to understand and the willingness to sign a written informed consent.
* Adequate organ and marrow function as defined below:
* Hematologic
* \- Absolute neutrophil count (ANC) ≥1,500 /mcL
* \- Platelets ≥100,000 /mcL
* \- Hemoglobin ≥9 g/dL
* Renal\*
* \- Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated (calculated per institutional standard) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min GFR for patient with creatinine levels \> 1.5 X institutional ULN
* Hepatic\*
* \- Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for
* \- Participants with total bilirubin levels \> 1.5 ULN
* \- AST or ALT ≤ 2.5 X ULN
* \- Albumin \>2.5 mg/dL
* If laboratory criteria are not met due to what the investigator determines to be a biologic cause (e.g. Gilbert's syndrome causing elevated bilirubin or excessive muscle mass affecting creatinine) or drug-related cause (e.g. elevating in transaminases due to HAART therapy, elevated INR due to anticoagulation) then the specific lab values will not be used to exclude patient from this trial. This determination will be made by PI.
Exclusion Criteria
* Any pulmonary nodule with a solid component \>8mm.
* Patients may not be receiving any other investigational agents at the time of enrollment.
* Uncontrolled intercurrent illness prior to starting therapy including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Exception: Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
* Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Exception: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
* Known HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with \<200 CD4+ T cells/microliter in the peripheral blood. HIV testing is not required for patients with no known history of HIV.
* Has known Hepatitis B or active Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). HBV and HCV testing is not required for patients with no known history of these viruses.
* History of allogeneic hematopoietic cell transplantation or solid organ transplantation.
* Receipt of a live vaccine, etanercept, or tumor necrosis factor-alpha inhibitors within 30 days of planned start of study drug
* Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps)Principal investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient.
* Patients may not be receiving any other investigational agents at the time of enrollment.
* Uncontrolled intercurrent illness prior to starting therapy including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Exception: Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
* Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Exception: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
* Known HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with \<200 CD4+ T cells/microliter in the peripheral blood. HIV testing is not required for patients with no known history of HIV.
* Has known Hepatitis B or active Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). HBV and HCV testing is not required for patients with no known history of these viruses.
* History of allogeneic hematopoietic cell transplantation or solid organ transplantation.
* Receipt of a live vaccine, etanercept, or tumor necrosis factor-alpha inhibitors within 30 days of planned start of study drug
* Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps)Principal investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cantargia AB
INDUSTRY
Sponsor Role
collaborator
Robert Samstein
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert Samstein
Associate Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert M Samstein, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Thomas Marron, MD, PhD
Role: STUDY_CHAIR
Icahn School of Medicine at Mount Sinai
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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. 2024 Oct 18:15266028241283713. doi: 10.1177/15266028241283713. Online ahead of print.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRMC-25-050
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY-25-00757
Identifier Type: -
Identifier Source: org_study_id