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Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib.

RecruitingPhase 2Ages 18 Years - 75 YearsAllGuangzhou Medical University
NCT06296745 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 treating non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. 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, the choice of treatme

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Male or female aged between 18 and 75 years. 2. Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations (L858R or Exon19Del). 3. Confirmed diagnosis of leptomeningeal metastasis according to ESMO/ EANO guidelines. 4. Progression after previous double doses of third-generation TKIs such as Osimertinib. 5. Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3. 6. No history of severe nervous system disease. 7. No severe dyscrasia. Exclusion Criteria: 1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11. 2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment. 3. Patients with poor compliance or other reasons that were unsuitable for this study
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What it tests

  • Pemetrexed
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Where

1 site
The Affiliated Huizhou Hospital, Guangzhou Medical University
Huizhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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