Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)

Summary

This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations

Timeline

Start

2020-02-13

Primary completion

2022-07-29

Completion

2026-04-22

Publications

• Soo RA, Cho BC, Kim JH, Ahn MJ, Lee KH, Zimina A, Orlov S, Bondarenko I, Lee YG, Lim YN, Lee SS, Lee KH, Pang YK, Fong CH, Kang JH, Lim CS, Danchaivijitr P, Kilickap S, Yang JC, Arslan C, Lee H, Park SN, Cicin I. Central Nervous System Outcomes of Lazertinib Versus Gefitinib in EGFR-Mutated Advanced NSCLC: A LASER301 Subset Analysis. J Thorac Oncol. 2023 Dec;18(12):1756-1766. doi: 10.1016/j.jtho.2023.08.017. Epub 2023 Oct 22.
• Cho BC, Ahn MJ, Kang JH, Soo RA, Reungwetwattana T, Yang JC, Cicin I, Kim DW, Wu YL, Lu S, Lee KH, Pang YK, Zimina A, Fong CH, Poddubskaya E, Sezer A, How SH, Danchaivijitr P, Kim Y, Lim Y, An T, Lee H, Byun HM, Zaric B. Lazertinib Versus Gefitinib as First-Line Treatment in Patients With EGFR-Mutated Advanced Non-Small-Cell Lung Cancer: Results From LASER301. J Clin Oncol. 2023 Sep 10;41(26):4208-4217. doi: 10.1200/JCO.23.00515. Epub 2023 Jun 28.

Drugs

Indications