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

A Clinical Trial of 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

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.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangzhou Medical University (Academic / other)
• Drugs / interventions: osimertinib, chemotherapy
• Locations: 1 site (Huizhou, Guangdong)
• Trial ID: NCT06304441 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of combining intrathecal pemetrexed with third-generation small molecule tyrosine kinase inhibitors (TKIs), such as osimertinib, against using TKIs alone in patients with leptomeningeal metastasis from epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The research will involve patients aged 18 to 75 who have confirmed diagnoses of NSCLC with specific EGFR mutations and leptomeningeal metastasis. The study will assess treatment outcomes based on established clinical guidelines and previous research indicating the efficacy of these treatments. By comparing these two approaches, the study seeks to determine if the combination therapy offers superior benefits for patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed EGFR mutation-positive NSCLC and leptomeningeal metastasis.

Not a fit: Patients with severe nervous system diseases or extensive systemic diseases without effective treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly improve outcomes for patients with leptomeningeal metastasis from EGFR mutation-positive NSCLC.

How similar studies have performed: Previous studies have shown promising results with similar treatment approaches, particularly with the use of osimertinib in this patient population.

Eligibility criteria

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. Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3.
5. No history of severe nervous system disease.
6. 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 this trial is running

Huizhou, Guangdong

• The Third People's Hospital of Huizhou (Huizhou Hospital of Guangzhou Medical University) — Huizhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Zhenyu Pan

Conditions Leptomeningeal Metastasis; Leptomeningeal metastasis; Intrathecal chemotherapy; Pemetrexed; Third-generation small molecule TKI drugs; Osimertinib; Epidermal growth factor receptor mutation