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New treatment option for Leptomeningeal Metastasis
Official title Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib.
ClinicalTrials.gov ID: NCT06296745
What this study is testing
What is Pemetrexed?
Pemetrexed is an investigational medicine, given as an once-weekly, being studied as a potential treatment for leptomeningeal metastasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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; WBC≥4000/mm3, Plt≥100000/mm3.
You likely can't join if
- Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less...
- Any evidence of extensive and lethal progressive systemic diseases without effective treatment.
- Patients with poor compliance or other reasons that were unsuitable for this study
See the full eligibility criteria
- 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; WBC≥4000/mm3, Plt≥100000/mm3.
- No history of severe nervous system disease.
- No severe dyscrasia.
- Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.
- Any evidence of extensive and lethal progressive systemic diseases without effective treatment.
- Patients with poor compliance or other reasons that were unsuitable for this study
The study team makes the final eligibility decision.
Where it's taking place
- Huizhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huizhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.