A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stage III) Following Chemoradiation Therapy

Summary

The "PACIFIC" trial confirmed that the consolidation therapy with durvalumab in patients with stage III, locally advanced, unresectable NSCLC that had not progressed after definitive platinum-based chemoradiation therapy improved the progression-free survival (PFS) by about 17 months. However, in PACIFIC, no significant differences between durvalumab and placebo were observed in PFS. Unmet need remains in development of successful consolidation therapy following chemoradiation therapy in patients with EGFR-mutant stage III unresectable NSCLC. A recent "ADAURA" study showed that Osimertinib as an adjuvant therapy after surgery significantly prolonged disease-free survival in EGFR mutation-positive patients. Lazertinib, like Osimertinib, is a third-generation EGFR TKI agent and has shown excellent anticancer effects in preclinical studies and in early clinical settings. Based on these results of the 3rd generation EGFR TKI, Lazertinib, it is expected that there is a clinical benefit Lazertinib as consolidation therapy. This study aims to investigate the clinical benefits of Lazertinib (Trade name: LECLAZA Tab) consolidation therapy for patients with EGFR mutation-positive, unresectable stage III NSCLC after definitive platinum-based chemoradiation therapy.

Timeline

Start

2022-06-30

Primary completion

2026-03-02

Completion

2026-03-02

Publications

• Background Choi J, Lee JE, Choi CM, Oh IJ, Lee KY, Jang TW, Lee SH, Kim EY, Park DW, Park SH, Lee SY. A phase II, multicenter study of lazertinib as consolidation therapy in patients with locally advanced, unresectable, EGFR mutation-positive non-small cell lung cancer (stage III) who have not progressed following definitive, platinum-based, chemoradiation therapy (PLATINUM trial). Thorac Cancer. 2022 Dec;13(23):3431-3435. doi: 10.1111/1759-7714.14663. Epub 2022 Oct 19.
• Wang W, Wang Q, Xu C, Li Z, Song Z, Zhang Y, Cai X, Zhang S, Lian B, Li W, Liu A, Zhan P, Liu H, Lv T, Miao L, Min L, Chen Y, Yuan J, Wang F, Jiang Z, Lin G, Pu X, Rao C, Lv D, Yu Z, Li X, Tang C, Zhou C, Xie C, Zhang J, Guo H, Chu Q, Meng R, Wu J, Zhang R, Wang L, Zhu Y, Hu X, Xie Y, Lin X, Cai J, Lan F, Feng H, Wang L, Yao W, Shi X, Huang J, Chen H, Zhang Y, Sun P, Wan B, Pang F, Xu Z, Wang K, Xia Y, Ye M, Wang D, Wei Q, Feng S, Zhou J, Zhang J, Lv D, Gao W, Kang J, Yu G, Liang X, Yu C, Shi L, Yang N, Wu L, Hong Z, Hong W, Fang M, Zhang Y, Lu Y, Wang G, Ma S, Si L, Fang W, Song Y. Chinese expert consensus on the multidisciplinary management of pneumonitis associated with immune checkpoint inhibitor. Thorac Cancer. 2022 Dec;13(23):3420-3430. doi: 10.1111/1759-7714.14693. Epub 2022 Oct 21.

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