Spots Global Cancer Trial Database for A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker

Study Description

Brief Summary: 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.

Detailed Description: The primary objective of this study was to evaluate PFS of laseratinib and bevacizumab combination therapy as the primary treatment for advanced lung cancer with EGFR mutation. For laseratinib monotherapy, the expected median PFS is 15 months. On the other hand, assuming the expected median PFS 27 months of laseratinib and bevacizumab combination therapy, the one-sided test alpha level is 0.05, the power 0.8) dropout rate should be approximately 120 (60 people per group) enrolled in this study. Patients would be enrolled in this study for 18 months and followed up to at least 24 months from the last patient enrollment date. This study is a phase 2 clinical trial, and the primary goal is PFS, and based on the log rank test, the laseratinib bevacizumab combination therapy group significantly increases PFS when one side p value \<0.05. Fisher's Fisher exact test or chi-square test will be used in consideration of laboratory data and laboratory test abnormalities or clinical adverse reactions.

Keywords

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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