Zorifertinib Plus Intra-Ommaya CSF Chemotherapy for Leptomeningeal Progression in NSCLC After Third-Generation EGFR-TKI

Summary

A Prospective Study of Zorifertinib Combined with Intra-Ommaya Reservoir Cerebrospinal Fluid Chemotherapy for Leptomeningeal Progression in NSCLC Patients After Third-Generation EGFR-TKI Therapy

Timeline

Start

2026-05-30

Primary completion

2027-05-30

Completion

2028-05-30

Publications

• Background Fan C, Jiang Z, Teng C, Song X, Li L, Shen W, Jiang Q, Huang D, Lv Y, Du L, Wang G, Hu Y, Man S, Zhang Z, Gao N, Wang F, Shi T, Xin T. Efficacy and safety of intrathecal pemetrexed for TKI-failed leptomeningeal metastases from EGFR+ NSCLC: an expanded, single-arm, phase II clinical trial. ESMO Open. 2024 Apr;9(4):102384. doi: 10.1016/j.esmoop.2024.102384. Epub 2024 Feb 19.
• Background Fan C, Zhao Q, Li L, Shen W, Du Y, Teng C, Gao F, Song X, Jiang Q, Huang D, Jin Y, Lv Y, Wei L, Shi T, Zhao X, Gao N, Jiang Z, Xin T. Efficacy and Safety of Intrathecal Pemetrexed Combined With Dexamethasone for Treating Tyrosine Kinase Inhibitor-Failed Leptomeningeal Metastases From EGFR-Mutant NSCLC-a Prospective, Open-Label, Single-Arm Phase 1/2 Clinical Trial (Unique Identifier: ChiCTR1800016615). J Thorac Oncol. 2021 Aug;16(8):1359-1368. doi: 10.1016/j.jtho.2021.04.018. Epub 2021 May 11.
• Background Montes de Oca Delgado M, Cacho Diaz B, Santos Zambrano J, Guerrero Juarez V, Lopez Martinez MS, Castro Martinez E, Avendano Mendez-Padilla J, Mejia Perez S, Reyes Moreno I, Gutierrez Aceves A, Gonzalez Aguilar A. The Comparative Treatment of Intraventricular Chemotherapy by Ommaya Reservoir vs. Lumbar Puncture in Patients With Leptomeningeal Carcinomatosis. Front Oncol. 2018 Nov 20;8:509. doi: 10.3389/fonc.2018.00509. eCollection 2018.
• Background Abbott NJ, Ronnback L, Hansson E. Astrocyte-endothelial interactions at the blood-brain barrier. Nat Rev Neurosci. 2006 Jan;7(1):41-53. doi: 10.1038/nrn1824.
• Background Abbott NJ, Patabendige AA, Dolman DE, Yusof SR, Begley DJ. Structure and function of the blood-brain barrier. Neurobiol Dis. 2010 Jan;37(1):13-25. doi: 10.1016/j.nbd.2009.07.030. Epub 2009 Aug 5.
• Background Wilcox JA, Jeng MY, Tischfield S, Sui JSY, Nemirovsky D, Heller G, Choudhury NJ, Ross JS, Rudin CM, Riely GJ, Kris MG, Donoghue M, Boire AA, Yu HA. Identifying the genomic landscape of EGFR-mutant lung cancers with central nervous system metastases. Ann Oncol. 2025 Oct;36(10):1142-1153. doi: 10.1016/j.annonc.2025.06.001. Epub 2025 Jun 16.
• Background Jia C, Xu Q, Zhao L, Kong F, Jia Y. Therapeutic role of EGFR - Tyrosine kinase inhibitors in non-small cell lung cancer with leptomeningeal metastasis. Transl Oncol. 2024 Jan;39:101832. doi: 10.1016/j.tranon.2023.101832. Epub 2023 Nov 25.
• Background Wang Y, Yang X, Li NJ, Xue JX. Leptomeningeal metastases in non-small cell lung cancer: Diagnosis and treatment. Lung Cancer. 2022 Dec;174:1-13. doi: 10.1016/j.lungcan.2022.09.013. Epub 2022 Oct 1.

Drugs

Indications