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Trial Title:
Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib.
NCT ID:
NCT06296745
Condition:
Leptomeningeal Metastasis
Conditions: Official terms:
Adenocarcinoma
Neoplasm Metastasis
Adenocarcinoma of Lung
Meningeal Carcinomatosis
Pemetrexed
Conditions: Keywords:
Leptomeningeal metastasis
Intrathecal chemotherapy
Pemetrexed
Osimertinib
Epidermal growth factor receptor mutation
Non-small-cell lung cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
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
Summary:
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 treating
non-small cell lung cancer patients with epidermal growth factor receptor (EGFR)
mutations. 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, the choice of treatment after resistance to targeted therapy is a hot topic in
clinical practice, with 78% of patients in the study above who responded to double-dose
osimertinib still showing progression at the time of follow-up. The purpose of this study
was to observe the safety and efficacy of intrathecal pemetrexed for leptomeningeal
metastasis from lung adenocarcinoma that progressed after a double dose of a
third-generation TKI such as osimertinib.
Detailed description:
This study is a single arm, open and phase II clinical trial. Consecutive patients with
leptomeningeal metastases from lung adenocarcinoma that progressed after a double dose of
a third-generation TKI such as osimertinib are enrolled in this study. Concomitant
regimen consisted of intrathecal chemotherapy (via lumbar puncture, pemetrexed 15 mg,
plus dexamethasone 5 mg, twice a week for 2 weeks as an induction phase, followed by once
a week for 4 weeks as a consolidation phase. Thereafter, the maintenance phase is once a
month). The RANO proposal for response criteria of leptomeningeal metastasis was used to
assess the clinical response in this study.
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. 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
March 20, 2024
Completion date:
March 20, 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/NCT06296745
