Clinical Trial 21767

Study Title

Phase 2: Using Biomarkers for Diagnosis, Risk Stratification of Post-Treatment Recurrence and Long-Term Surveillance of Lung Cancer

Summary

This study is designed to evaluate the accuracy of lung cancer biomarkers found in the blood in determining if a lung nodule is cancer or benign. Investigators also plan to use another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer so that they can be offered additional drug treatment that will improve their chances of long-term cure. Finally, investigators plan to use one of the blood-based biomarkers to detect any late cancer recurrence

Objective

Primary Objectives: 1. Stratify postoperative patients with pathologic lymph node negative non-small cell lung cancers < 5 cm diameter (Stage IA-IIA) for the risk of recurrent cancer using a tumor-tissue based biomarker test and a blood-based biomarker. 2. If the tumor tissue biomarker indicates the tumor is intermediate to high risk for recurrence, patients will be referred to a medical oncologist who will recommend adjuvant chemotherapy. Secondary Objective: 1. Assess the diagnostic accuracy of the two blood-based biomarkers in discriminating between benign and early-stage malignant lung nodules 6-50 mm in diameter and use one of the blood-based biomarker tests to evaluate postoperative early-stage lung cancer patients for recurrent tumor or second primary cancer at their routine 6-monthly surveillance chest CT scan visit.