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

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 fac

Trial Details

NCT ID

NCT06304441

Phase

Sponsor

Guangzhou Medical University

Status

RECRUITING

Cancer Type

Non-Small Cell (NSCLC) Lung Cancer

Interventions

Osimertinib
Pemetrexed

Locations (sample)

Huizhou, Guangdong, China|23.11147,114.41523

Key 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.
Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3.

For full eligibility, visit ClinicalTrials.gov.

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