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Trial Title:
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
NCT ID:
NCT06304441
Condition:
Leptomeningeal Metastasis
Conditions: Official terms:
Neoplasm Metastasis
Meningeal Carcinomatosis
Pemetrexed
Osimertinib
Conditions: Keywords:
Leptomeningeal metastasis
Intrathecal chemotherapy
Pemetrexed
Third-generation small molecule TKI drugs
Osimertinib
Epidermal growth factor receptor mutation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
Double-dose of TKI (e.g. 'osimertinib' 160 mg) was administered orally once daily until
disease progression or unmanageable drug-related toxicity.
Arm group label:
Group A
Arm group label:
Group B
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Pemetrexed 15 mg was administered with dexamethasone 5 mg via intraventricular or via
lumbar puncture. First, induction intrathecal chemotherapy, twice per week for 2 weeks;
then consolidation intrathecal chemotherapy, once per week for 4 weeks; and maintenance
intrathecal chemotherapy, once per month until disease progression or unmanageable
drug-related toxicity.
Arm group label:
Group A
Summary:
Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal
metastases. 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
the treatment of non-small cell lung cancer patients with epidermal growth factor
receptor (EGFR) mutations. Due to its small molecule properties, it can effectively
penetrate the central nervous system barrier and deliver an effective antitumor effect.
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,
whether third-generation small molecule TKI drugs (e.g. 'osimertinib') combined with
intrathecal pemetrexed could benefit patients with LM from EGFR- mutant NSCLC remains
undetermined.
Detailed description:
The aim of this Study is to compare the effects of intra-pemetrexed Plus third-generation
small molecule TKI drugs (e.g. 'osimertinib') versus third-generation small molecule TKI
drugs alone in leptomeningeal metastasis from EGFR mutation positive NSCLC.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Third People's Hospital of Huizhou (Huizhou Hospital of Guangzhou Medical University)
Address:
City:
Huizhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhenyu Pan
Phone:
+8615804302753
Email:
dr-zypan@163.com
Contact backup:
Last name:
Guozi Yang
Phone:
+8615804302755
Email:
guoziyang_1982@163.com
Start date:
March 2024
Completion date:
March 2026
Lead sponsor:
Agency:
Guangzhou Medical University
Agency class:
Other
Source:
Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06304441
