Each subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure for generic alteration with Next Generation Sequencing.

Each subject suspected or diagnosed of lung cancer will undergo bronchoscopic procedure. First, ultrathin bronchoscope is inserted and placed within tumor under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. Then, intratumoral washing is performed. Subsequently, transbronchial lung biopsy is performed under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance.

Detection rate of druggable genetic alteration is defined as the number of true positive druggable genetic alterations detected by Next Generation Sequencing, divided by the total number of attempts. Druggable mutations were defined the presence of following genetic alterations: 1) EGFR mutation, 2) KRAS G12C mutation, 3) ALK rearrangement, 4) ROS1 rearrangement, 5) BRAF V600E mutation, 6) NTRK1/2/3 gene fusion, 7) METex14 skipping mutation, 8) RET rearrangement and 9) ERBB2 (HER2) mutation. The full patient set included all enrolled subjects.

The concordance rate of druggable genetic alterations detected in bronchial washing fluid by Next Generation Sequencing is compared with that in plasma and tissue in the analysis intent group. Druggable mutations were defined the presence of following genetic alterations: 1) EGFR mutation, 2) KRAS G12C mutation, 3) ALK rearrangement, 4) ROS1 rearrangement, 5) BRAF V600E mutation, 6) NTRK1/2/3 gene fusion, 7) METex14 skipping mutation, 8) RET rearrangement and 9) ERBB2 (HER2) mutation. The analysis intent group consisted of the subset of subjects for whom Next Generation Sequencing testing was successfully performed with tissue samples.