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

Launched by GUANGZHOU MEDICAL UNIVERSITY · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a combination of intrathecal pemetrexed, a type of chemotherapy, and third-generation small molecule drugs like osimertinib can improve treatment outcomes for patients with leptomeningeal metastasis caused by specific mutations in non-small cell lung cancer (NSCLC). Leptomeningeal metastasis is when cancer spreads to the membranes surrounding the brain and spinal cord, making it harder to treat. The research aims to find out if using both treatments together is more effective than using the TKI drugs alone.

To participate in this trial, individuals should be between 18 and 75 years old and have a confirmed diagnosis of NSCLC with certain mutations (L858R or Exon19Del). They also need to have been diagnosed with leptomeningeal metastasis and have normal liver and kidney function. Participants can expect to receive close monitoring and support throughout the trial as researchers determine the best treatment options for this challenging condition. It's important to note that individuals with severe nervous system issues or other serious health problems may not be eligible to join the study.

Gender

ALL

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.