Nodify XL2 Classifier Clinical Utility Study in 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 evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.

A multicenter, randomized controlled study with a blinded control arm. Open label arm is observational for lung nodule management. The clinical trial will evaluate the clinical utility of the Nodify XL2 integrated classifier when used in the clinical management of newly identified solid lung nodules assessed as < 50% risk of cancer by Mayo risk prediction algorithm.

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