Evaluating the Nodify XL2 test for managing low to moderate risk lung nodules

A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules

This study is testing if the Nodify XL2 test can help doctors make better treatment decisions for patients with low to moderate risk solid lung nodules.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Biodesix, Inc. (Industry-sponsored)
• Locations: 26 sites (Aurora, Colorado and 25 other locations)
• Trial ID: NCT04171492 on ClinicalTrials.gov

What this trial studies

This observational study assesses how the Nodify XL2 test results influence the clinical management of newly identified solid lung nodules that are considered to have a low to moderate risk of cancer. It involves a multicenter approach with a randomized controlled design, where one arm is open-label and observational. The study specifically targets lung nodules that are solid, between 8mm and 30mm in size, and assessed to have a cancer risk of 65% or less using the Mayo risk prediction algorithm.

Who should consider this trial

Good fit: Ideal candidates are individuals over 40 years old with newly discovered solid lung nodules that are incidentally identified and assessed as having a low to moderate risk of cancer.

Not a fit: Patients with prior lung cancer diagnoses or those whose nodules are part-solid or ground glass opacity will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve decision-making in the management of lung nodules, potentially reducing unnecessary invasive procedures.

How similar studies have performed: Other studies have shown promise in using similar classifiers for lung nodule management, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements
2. Subject is \> 40 years of age at the time of the discovery of the lung nodule of concern
3. Subject's lung nodule of concern meets the following:

   * Was incidentally identified or detected during lung cancer screening
   * Is a solid nodule
   * Has maximal dimension of \> 8mm and \< 30mm
4. The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment
5. The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less

Exclusion Criteria:

1. Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern
2. Nodule of concern is part-solid or Ground Glass Opacity (GGO)
3. Prior diagnosis of lung cancer
4. Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer
5. Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment
6. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern
7. Any illness or factor that will inhibit compliance with study participation

Where this trial is running

Aurora, Colorado and 25 other locations

• University of Colorado — Aurora, Colorado, United States (Recruiting)
• National Jewish Health — Denver, Colorado, United States (Withdrawn)
• Massachusetts General Hospital — Boston, Connecticut, United States (Recruiting)
• Beth Israel Deaconess — Boston, Connecticut, United States (Recruiting)
• MedStar — Washington, District of Columbia, United States (Recruiting)
• Indiana University — Indianapolis, Indiana, United States (Recruiting)
• The Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• The Washington University — Saint Louis, Missouri, United States (Recruiting)
• Mount Sinai Health System — New York, New York, United States (Recruiting)
• Northwell Health — New York, New York, United States (Recruiting)
• The University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
• Duke University — Durham, North Carolina, United States (Recruiting)
• Southeastern Research Center — Winston-Salem, North Carolina, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• The Ohio State University — Coulmbus, Ohio, United States (Recruiting)
• The Oregon Clinic — Portland, Oregon, United States (Recruiting)
• Ralph H Johnson VA Medical Center — Charleston, South Carolina, United States (Recruiting)
• Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
• Prisma Health — Greenville, South Carolina, United States (Recruiting)
• University of Texas Southwestern — Dallas, Texas, United States (Recruiting)
• University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
• Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
• University of Calgary — Calgary, Alberta, Canada (Recruiting)
• McGill University Health Centre — Montréal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Steven Springmeyer — Biodesix, Inc.
• Study coordinator: Niki Givens

Conditions Nodule Solitary Pulmonary; Non-small Cell Carcinoma