NCT06296745 Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib.
| NCT ID | NCT06296745 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Guangzhou Medical University |
| Condition | Leptomeningeal Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2025-09-01 with a primary completion date of 2026-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Zhenyu Pan
PRINCIPAL INVESTIGATOR
Guangzhou Medical University
Frequently Asked Questions
Who can join the NCT06296745 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Leptomeningeal Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06296745 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06296745 currently recruiting?
Yes, NCT06296745 is actively recruiting participants. Contact the research team at dr-zypan@163.com for enrollment information.
Where is the NCT06296745 trial being conducted?
This trial is being conducted at Huizhou, China.
Who is sponsoring the NCT06296745 clinical trial?
NCT06296745 is sponsored by Guangzhou Medical University. The principal investigator is Zhenyu Pan at Guangzhou Medical University. The trial plans to enroll 36 participants.