Actively Recruiting
Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib.
Led by Guangzhou Medical University · Updated on 2026-01-30
36
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 treatment after resistance to targeted therapy is a hot topic in clinical practice, with 78% of patients in the study above who responded to double-dose osimertinib still showing progression at the time of follow-up. The purpose of this study was to observe the safety and efficacy of intrathecal pemetrexed for leptomeningeal metastasis from lung adenocarcinoma that progressed after a double dose of a third-generation TKI such as osimertinib.
CONDITIONS
Official Title
Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged between 18 and 75 years
- Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations (L858R or Exon19Del)
- Confirmed diagnosis of leptomeningeal metastasis according to ESMO/EANO guidelines
- Progression after previous double doses of third-generation TKIs such as Osimertinib
- Normal liver and kidney function; white blood cells ≥4000/mm3, platelets ≥100000/mm3
- No history of severe nervous system disease
- No severe blood disorders
You will not qualify if you...
- Evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, or Glasgow Coma Score less than 11
- Presence of extensive and lethal progressive systemic diseases without effective treatment
- Poor compliance or other unsuitable reasons for participation in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Huizhou Hospital, Guangzhou Medical University
Huizhou, Guangdong, China, 516000
Actively Recruiting
Research Team
Z
Zhenyu Pan
CONTACT
G
Guozi Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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