Using gefitinib or Osimertinib, an EGFR tyrosine kinase inhibitor (TKI), in patients with active mutations in epithelial cell growth factor receptors (EGFR), 70% response rate (CR+PR) and 90% disease control rate (CR+PR+SD) compared to the current non-small cell therapy, which is significant in the EFRT treatment. However, resistance causes recurrence in most patients. Therefore, it is necessary to develop a more effective treatment. Recently, in Japan, combined allotinib and bevacizumab therapy as primary therapy in non-small cell lung cancer patients with EGFR mutation improved PFS statistically significantly compared to allotinib monotherapy, suggesting the possibility of a new treatment (Hazard ratio 0.605, 95% CI 0.417-0.877, P=0.016). In addition, subsequent osmutinib and bevacizumab combination therapy showed a significant difference in PFS in the smoker group, although they did not show significant improvement in PFS in the entire patient group. (Hazard ratio 0.605, 95% CI 0.417-0.877, P=0.016). Since EGFR mutated lung cancer is highly frequent in Korea, it is necessary to develop more effective treatments for such patients. Therefore, we propose this clinical trial to find out the efficacy of lasertinib and bevacizumab combination therapy.
Histologically confirmed patients with locally progressive or metastatic non-small cell lung cancer (IIIB or IV) who have not been diagnosed as squamous cell carcinoma.
Patients with one or more measurable lesions in accordance with the RECIST criteria (Version 1.1), tumor lesions located at the previous irradiation site, are considered measurable if progress has been made in those lesions.
Patients with institutionalized EGFR mutation (exon 19 deletion or L858R)
Patients with a history of smoking, including those who are currently smoking (defined as those who have smoked more than 100 cigarettes in their lifetime)
Average of corrected QT intervals at rest (QTc intervals corrected by Fredericia formula) >470 msec based on QTc values calculated by ECG equipment by the test institution during screening.
clinically significant abnormal findings found in the rhythm, conduction, or morphology of the ECG at rest (e.g., complete left block, 3rd degree heart block, 2nd degree heart block)
All factors that increase the risk of QTc prolongation or arrhythmia, including heart failure, hypokalemia, family history of congenital QT prolongation syndrome, sudden death of causes under the age of 40 in the immediate family, combined drugs known to prolong QT spacing and induce Torsades de Points (TdP).