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

Leptomeningeal Metastasis Clinical Trial

Official title:
A Clinical Trial of 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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06304441
Study type	Interventional
Source	Guangzhou Medical University
Contact	Zhenyu Pan
Phone	+8615804302753
Email	dr-zypan@163.com
Status	Recruiting
Phase	N/A
Start date	March 2024
Completion date	March 2026

View Details

See also
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Recruiting	`NCT02803619` - A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis	N/A
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Completed	`NCT04420598` - DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease	Phase 2
Completed	`NCT02071056` - Circulating Tumor DNA in Cerebrospinal Fluid as an Early Biomarker of Leptomeningeal Metastasis (LM)
Not yet recruiting	`NCT05805631` - Intrathecal Pemetrexed for Leptomeningeal Metastasis in EGFR-Mutant NSCLC	Phase 2
Recruiting	`NCT05385185` - Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer	Phase 2
Terminated	`NCT04729348` - Pembrolizumab And Lenvatinib In Leptomeningeal Metastases	Phase 2
Not yet recruiting	`NCT06296745` - Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib.	Phase 2
Recruiting	`NCT04778800` - A Dose Exploration Study of Almonertinib for EGFRm NSCLC Patients With Brain/Leptomeningeal Metastasis (ARTISTRY)	N/A
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Not yet recruiting	`NCT04356118` - Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis	Phase 4
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Not yet recruiting	`NCT04944069` - Almonertinib With Bevacizumab for EGFR-Mutant NSCLC Patients With Leptomeningeal Metastasis	N/A
Withdrawn	`NCT03974204` - Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.