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Study identifier: NCT06304441 Synced from ClinicalTrials.gov · July 29, 2026
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Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer

Condition: Leptomeningeal Metastasis  ·  Sponsor: Guangzhou Medical University

PhaseNA
Planned participants100
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases. Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in the treatment of non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. Due to its small molecule properties, it can effectively penetrate the central nervous system barrier and deliver an effective antitumor effect. An international multi-center clinical study published in 2019 confirmed that double-dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, whether third-generation small molecule TKI drugs (e.g. 'osimertinib') combined with intrathecal pemetrexed could benefit patients with LM from EGFR- mutant NSCLC remains undetermined.

This description comes directly from the study's public registry record.

Talk to the study team

Zhenyu Pan  ·  +8615804302753  ·  dr-zypan@163.com

Guozi Yang  ·  +8615804302755  ·  guoziyang_1982@163.com

Always discuss trial participation with your own doctor first.

Locations (1)

The Third People's Hospital of Huizhou (Huizhou Hospital of Guangzhou Medical University)Huizhou, Guangdong, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06304441