Intrathecal pemetrexed for leptomeningeal metastases after osimertinib in lung adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single‑arm, open‑label phase II trial enrolling patients with leptomeningeal metastases from EGFR‑mutant lung adenocarcinoma who progressed after double‑dose third‑generation TKIs such as osimertinib. Treatment is intrathecal pemetrexed (15 mg) combined with dexamethasone via lumbar puncture, given twice weekly for two weeks (induction), once weekly for four weeks (consolidation), then monthly for maintenance. Clinical and radiographic responses will be measured using the RANO leptomeningeal criteria, and safety and tolerability will be closely monitored. The trial targets a population with limited standard options after targeted therapy resistance.

Why it matters

Who can join: the full rules

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

Where it's running

• The Affiliated Huizhou Hospital, Guangzhou Medical University
  Huizhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Zhenyu Pan — Guangzhou Medical University
• Study coordinator: Zhenyu Pan
• Email: dr-zypan@163.com
• Phone: +8615804302753

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing intra-pemetrexed with osimertinib for treating leptomeningeal metastasis in lung cancer

  This study is testing whether combining a specific type of chemotherapy with a targeted lung cancer drug can help people with leptomeningeal metastasis from lung cancer feel better compared to using the targeted drug alone.

  Recruiting Guangzhou Medical University · Huizhou, Guangdong · NCT06304441

• Pemetrexed injected into the spinal fluid for EGFR‑mutant lung cancer that has spread to the leptomeninges.

  This tests whether giving pemetrexed directly into the spinal fluid helps people with EGFR‑mutant non‑small cell lung cancer whose cancer has spread to the leptomeninges after osimertinib has stopped working.

  Recruiting Phase 2 Taipei Veterans General Hospital, Taiwan · Taipei, Taiwan · NCT05805631

• Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases

  This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.

  Recruiting Phase 2 Cho Ray Hospital · Ho Chi Minh City · NCT07911449

• Osimertinib with Cyclosporine A for EGFR-mutant NSCLC

  This phase II study tests whether adding cyclosporine A to osimertinib helps people with EGFR-mutant metastatic NSCLC who still have detectable tumor DNA in blood.

  Recruiting Phase 2 NYU Langone Health · New York, New York · NCT07874490

• Brain-avoiding proton craniospinal irradiation for leptomeningeal metastases

  This study tests BRAVO pCSI, a proton therapy approach that avoids certain brain regions, to see if it helps adults with leptomeningeal metastases from solid tumors.

  Recruiting University of Miami · Miami, Florida · NCT07789912

• Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic NSCLC

  This trial tests whether surgically removing the main lung tumor, after initial osimertinib therapy, helps people with EGFR-mutant oligometastatic non-small cell lung cancer live longer without disease progression.

  Recruiting Phase 3 National Taiwan University Hospital · Taipei, Taipei City · NCT07738172

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.