Nadunolimab for Lung Cancer Prevention

Overseen By Rashmi Unawane

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Robert Samstein

Must not be taking: Immunosuppressants, Steroids, Antivirals, others

Disqualifiers: Pregnancy, Immunodeficiency, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called nadunolimab, an experimental therapy, to determine its effectiveness in preventing lung cancer in current or former smokers. The trial targets individuals with specific lung nodules that have shown some growth over time but are not yet suitable for surgery. Ideal candidates have smoked the equivalent of 20 or more packs of cigarettes per year and have experienced changes in their lung nodules during annual check-ups. Participants will receive nadunolimab every three weeks for a total of four doses, and the study may last up to five years for each person. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that nadunolimab is likely to be safe for humans?

Research has shown that nadunolimab is generally safe. In studies involving patients with advanced lung cancer, nadunolimab combined with other treatments was usually well-tolerated. For instance, one study found that using nadunolimab with standard chemotherapy produced good results without serious side effects. Another study found that combining nadunolimab with pembrolizumab (a type of cancer medicine) was safe and well-tolerated in patients with solid tumors. These findings suggest that nadunolimab remains relatively safe, even when used with other cancer treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Nadunolimab is unique because it targets a specific protein involved in lung cancer development, potentially stopping the disease before it starts. Unlike standard treatments for lung cancer that primarily focus on shrinking existing tumors, like chemotherapy or targeted therapy, Nadunolimab aims to prevent the cancer altogether. This novel approach could offer a proactive strategy, reducing the risk of lung cancer developing in the first place. Researchers are excited because this prevention-focused treatment could revolutionize how we approach lung cancer, potentially leading to fewer cases and improved outcomes for patients.

What evidence suggests that nadunolimab might be an effective treatment for lung cancer prevention?

Research has shown that nadunolimab holds promise for treating advanced lung cancer. In earlier studies, when combined with chemotherapy, 88% of patients experienced a halt in disease progression. On average, patients lived 7.2 months without cancer worsening and had a total survival of 13.7 months. This indicates that patients generally lived longer without their condition deteriorating. The treatment proved particularly effective with platinum-based chemotherapies. Although these results pertain to advanced lung cancer, they suggest that nadunolimab might also help prevent lung cancer in high-risk individuals. Participants in this trial will receive nadunolimab to evaluate its potential in lung cancer prevention. ^{1 2 3 6 7}

Who Is on the Research Team?

Robert M Samstein, MD, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Thomas Marron, MD, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are current or former heavy tobacco smokers with high-risk lung nodules showing progression but not requiring surgery. They must be able to provide blood samples, use contraception if of childbearing potential, and have good organ function. Exclusions include HIV with detectable viral load, transplant history, other treatments at enrollment time, pregnancy or nursing, active autoimmune disease treated within a year, certain medication use within 30 days prior to the study drug start date.

Inclusion Criteria

I am 18 years old or older.

Participants must be current or former tobacco smokers (>20 pack years)

I am mostly active and can care for myself, despite any long-term disabilities like cerebral palsy.

Exclusion Criteria

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

I have had a bone marrow or organ transplant.

Patients may not be receiving any other investigational agents at the time of enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10mg/kg Nadunolimab administered every 3 weeks for 4 doses

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up imaging timepoints past 3 months for up to 2 years

2 years

Extension

Participants may continue to be monitored for progression-free survival and other outcomes

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Nadunolimab

Trial Overview

The trial is testing nadunolimab as a preventive treatment for people with high-risk lung lesions due to smoking. Participants will receive this immunotherapy and be monitored up to five years to see how it affects the progression of their lung nodules.

How Is the Trial Designed?

Group I: Nadunolimab Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Robert Samstein

Lead Sponsor

Cantargia AB

Industry Sponsor

Trials

6

Recruited

450+

Citations

1.

cantargia.com

cantargia.com/en/press-releases/cantargia-announces-publication-of-clinical-data-showing-benefit-of-nadunolimab-combination-therapy-in-advanced-lung-cancer

Cantargia announces publication of clinical data showing ...

Promising efficacy data with median PFS of 7.2 months (95%CI 5.6–9.2), median OS of 13.7 months (95%CI 11.1–18.3), and 1-year survival of 54 ...

2.

cancernetwork.com

cancernetwork.com/view/nadunolimab-combo-exhibits-early-efficacy-in-advanced-nsclc

Nadunolimab Combo Exhibits Early Efficacy in Advanced ...

A total of 33% of patients experienced stable disease as best response, for a disease control rate (DCR) of 88% (95% CI, 73%-96%). The median ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40680438/

Safety, efficacy, and analysis of biomarkers in patients with ...

Conclusions: Nadunolimab plus platinum-based doublet chemotherapies showed promising efficacy in advanced NSCLC, with the greatest benefit in ...

4.

targetedonc.com

targetedonc.com/view/nadunolimab-misses-efficacy-mark-in-tnbc-despite-strong-os

Nadunolimab Misses Efficacy Mark in TNBC, Despite ...

New data from the TRIFOUR trial show that nadunolimab plus chemotherapy offers no significant survival benefit in metastatic triple-negative ...

5.

lungcancerjournal.info

lungcancerjournal.info/article/S0169-5002(25)00556-2/fulltext

Safety, efficacy, and analysis of biomarkers in ... - Lung Cancer

This study demonstrated the efficacy and safety of nadunolimab plus platinum doublet in patients with advanced NSCLC.

6.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.9089

Safety, efficacy and biomarker data in patients with non- ...

NCG shows promising efficacy in NSCLC with a trend for dose response, and long-term disease control by nadunolimab monotherapy post chemo with good safety.

7.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(24)02590-0/fulltext

1012P Safety, tolerability, and efficacy of nadunolimab in ...

Nadunolimab with pembrolizumab was safe and well tolerated in patients with advanced solid tumors. Prolonged survival was observed in a subset of patients with ...