Biomarker Screening for Lung Cancer

(NYULCBC Trial)

Overseen By Rosemary M Schluger

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Pregnancy, Prior malignancy, others

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

Compensation: Varies

Number of Visits: 2

10850 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance lung cancer screening by studying biomarkers, substances in the body that can indicate cancer presence. The goal is to detect lung cancer early and aid in planning effective treatments. Individuals who have smoked the equivalent of a pack a day for 20 years or more, or who have been referred for lung nodule evaluation, might be suitable for this study. As a Phase 2 trial, this research measures the effectiveness of the screening method in an initial, smaller group, offering participants a chance to contribute to advancements in early lung cancer detection.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this screening is safe for participants?

Research has shown that using biomarkers for lung cancer screening is generally safe. Biomarkers are substances in the body that can indicate cancer. Studies have found that tests for these biomarkers, such as taking a small tissue sample from the lungs, are usually well-tolerated by patients.

No major reports of serious side effects from these tests have emerged. Most patients undergo the tests without significant problems. The purpose of using biomarkers is to detect lung cancer early when it's easier to treat, aiding doctors in planning more effective treatments. While any medical test carries some risk, evidence suggests that biomarker screening for lung cancer is a safe option for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on identifying biomarkers and improving screening methods for lung cancer. Unlike traditional screening techniques, which often rely on imaging and may detect cancer at a later stage, this approach aims to catch the disease earlier by identifying specific biological markers in the body. Early detection can significantly improve treatment outcomes, making this a promising area of research. By refining how we screen for lung cancer, we hope to increase early diagnosis rates and improve survival chances for patients.

What evidence suggests that this screening is effective for lung cancer?

Research has shown that biomarker screening is a promising method for early lung cancer detection. One study found this method to be 93% accurate in identifying individuals without cancer. However, it correctly identified cancer in only 40% of cases, which is less than ideal. Despite this, another report suggests that thorough biomarker testing can help doctors select more effective treatments. Overall, early detection of lung cancer with these methods could significantly reduce mortality from the disease. ^{1 6 7 8 9}

Who Is on the Research Team?

James J. Tsay, MD, MSc

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Inclusion Criteria

Rule-Out Lung cancer group

Screening Cohort

At high- or low-risk for lung cancer

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Biomarker Identification

Participants undergo tests to identify and validate biomarkers for early detection of lung cancer

4-6 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for preneoplastic cellular changes and lesions

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Screening

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. iaslc.org iaslc.org/science-research/scientific-projects/iaslc-global-survey-biomarker-testing-lung-cancer-2024-update

IASLC Global Survey on Biomarker Testing in Lung Cancer Biomarker testing is essential in lung cancer care, allowing for personalized diagnosis and treatment. Our survey is now closed.

2. lung.org lung.org/media/press-releases/fy26-solc-national

New Report: Lung Cancer Advancements Are Saving More ... The report shows progress in coverage of comprehensive biomarker testing for lung cancer, which can help physicians identify better, more ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6494979/

Biomarkers in lung cancer screening: achievements ... In a clinical validation study including all lung cancer histologies and stages the panel performed well with 93% specificity, but only 40% sensitivity.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0306163

Five year mortality in an RCT of a lung cancer biomarker to ... Following the landmark National Lung Screening Trial (NLST) LDCT screening has been shown to detect cancers earlier and reduce lung cancer mortality by 20–25% [ ...

5. jnccn.org jnccn.org/view/journals/jnccn/21/9/article-p934.xml?print

Biomarker Testing, Treatment, and Outcomes in Patients ... Background: Little is known about the impact of up-front biomarker testing on long-term outcomes in patients with advanced or metastatic ...

6. jto.org jto.org/article/S1556-0864(25)00722-1/fulltext

Safety and Sample Adequacy for Comprehensive ... Safety and sample adequacy for comprehensive biomarker testing of bronchoscopic biopsies: An American Association of Bronchology and Interventional Pulmonology ...

7. lungevity.org lungevity.org/patients-care-partners/navigating-your-diagnosis/biomarker-testing

Biomarker Tests Comprehensive biomarker testing is used among diagnosed lung cancer patients to determine the presence of particular mutations or of a particular protein.

8. aacrjournals.org aacrjournals.org/cebp/article/29/12/2411/72168/Biomarkers-for-Lung-Cancer-Screening-and

Biomarkers for Lung Cancer Screening and Detection Biomarkers have tremendous potential to improve early detection of lung cancer by refining lung cancer risk, stratifying positive CT scans, and ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2762044

Assessment of Biomarker Testing for Lung Cancer ... This exploratory study analyzes the cost-effectiveness of incorporating biomarkers into eligibility assessment for lung screening.