Intrathecal pemetrexed combined with involved-field radiotherapy as a first-line intra-CSF therapy for leptomeningeal metastases from solid tumors: a phase I/II study.
Zhenyu Pan, Guozi Yang, Hua He...
https://pubmed.ncbi.nlm.nih.gov/32733606Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06304441
Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From EGFR Mutation-Positive Non-Small-cell Lung Cancer
Led by Guangzhou Medical University · Updated on 2025-09-29
100
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of combining intrathecal pemetrexed with third-generation small molecule tyrosine kinase inhibitors (TKIs), such as osimertinib, versus TKIs alone in treating leptomeningeal metastasis in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Intrathecal chemotherapy is a common treatment for leptomeningeal metastases, and osimertinib has shown promise in improving outcomes in this patient group. However, it remains unclear whether adding intrathecal pemetrexed to osimertinib offers additional benefits. Participants are randomly assigned to one of two groups: one receives intrathecal pemetrexed combined with a third-generation TKI like osimertinib, while the other receives the TKI alone. Osimertinib is taken orally at a double dose of 160 mg daily until disease progression or intolerable side effects occur. Pemetrexed is delivered intrathecally with dexamethasone, starting with induction chemotherapy twice weekly for two weeks, then consolidation once weekly for four weeks, followed by monthly maintenance until progression or unacceptable toxicity. During the study, participants will be monitored for clinical response up to six months from randomization, with evaluations of disease progression and survival. Researchers will also track treatment-related side effects during this period. The study includes assessments of overall survival from enrollment until death or last follow-up, with a minimum follow-up of seven months. The total participation duration varies depending on disease progression and treatment tolerance.
CONDITIONS
Brief 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
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged between 18 and 75 years
- Histologically or cytologically confirmed non-small cell lung cancer with activating EGFR mutations (L858R or Exon19Del)
- Confirmed leptomeningeal metastasis diagnosis according to ESMO/EANO guidelines
- Normal liver and kidney function with WBC ≥4000/mm3 and platelet count ≥100000/mm3
- No history of severe nervous system disease
- No severe blood disorders
You will not qualify if you...
- Evidence of nervous system failure, such as severe encephalopathy, grade 3 or 4 leukoencephalopathy, or Glasgow Coma Score less than 11
- Extensive and lethal progressive systemic diseases without effective treatment
- Poor compliance or unsuitable for study participation for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Until disease progression or unmanageable drug-related toxicity
Participants receive either intra-pemetrexed plus third-generation small molecule TKI drugs (e.g. osimertinib) or third-generation small molecule TKI drugs alone. Osimertinib is taken orally once daily until disease progression or unmanageable toxicity. Pemetrexed is administered intrathecally with an induction phase twice per week for 2 weeks, consolidation once per week for 4 weeks, and maintenance once per month until disease progression or unmanageable toxicity.
Twice-weekly visits for 2 weeks, then weekly visits for 4 weeks, then monthly visits thereafter
Trial Site Locations
Total: 1 location
1
The Third People's Hospital of Huizhou (Huizhou Hospital of Guangzhou Medical University)
Huizhou, Guangdong, China
Actively Recruiting
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Research Team
Z
Zhenyu Pan
G
Guozi Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
A Pilot Phase 1 Study of Intrathecal Pemetrexed for Refractory Leptomeningeal Metastases From Non-small-cell Lung Cancer.
Zhenyu Pan, Guozi Yang, Jiuwei Cui...
https://pubmed.ncbi.nlm.nih.gov/31544065Osimertinib in Patients With Epidermal Growth Factor Receptor Mutation-Positive Non-Small-Cell Lung Cancer and Leptomeningeal Metastases: The BLOOM Study.
James C H Yang, Sang-We Kim, Dong-Wan Kim...
https://pubmed.ncbi.nlm.nih.gov/31809241