Monitoring ctDNA in cerebrospinal fluid for NSCLC treatment

A Single-center Prospective Cohort Study to Explore the Efficacy and Prognosis of Dynamic Monitoring of Cerebrospinal Fluid ctDNA

This study is testing a new treatment for patients with advanced lung cancer that has spread to the brain, to see how well it works and if monitoring their cerebrospinal fluid can help improve their care.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Province Nanjing Brain Hospital (Academic / other)
• Drugs / interventions: vormetinib, chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06315686 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) who have leptomeningeal metastasis. Participants will receive vormetinib in combination with OMMAYA lateral ventricle chemotherapy using pemetrexed, while their cerebrospinal fluid (CSF) ctDNA will be dynamically monitored. The study aims to analyze the ctDNA gene mutation profiles and explore their relationship with treatment efficacy and prognosis. Additionally, it investigates the safety and efficacy of drug vacation strategies to minimize side effects and improve patient tolerance.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with advanced EGFR-mutated NSCLC and leptomeningeal metastasis who meet specific health criteria.

Not a fit: Patients who do not qualify for lateral ventricular chemotherapy or have a history of allergy to vormetinib may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel approach to monitoring treatment response and improving outcomes for patients with advanced NSCLC and leptomeningeal metastasis.

How similar studies have performed: While the approach of monitoring ctDNA in CSF is innovative, similar studies have shown promise in other contexts, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Advanced NSCLC patient with EGFR mutation, associated with leptomeningeal metastasis
* Patients who meet the requirements of OMMAYA cystlateral ventricle chemotherapy
* Age \> 18 years
* Complete serologic tumor markers (CEA, SCC) and imaging data (enhanced CT and/or MRI, PET-CT)
* Liver, kidney, and hematologic measures were normal (as measured by laboratory testing within 1 week before enrollment in the absence of ongoing supportive care), with a neutrophil count of more than 1.5×109/L, a platelet count of more than 100×109/L, and a hemoglobin level of more than 9.0g/dl ，Bilirubin normal or \<1.5×ULN; AST(SGOT), ALT(SGPT) \<2.5×ULN; Serum creatinine \<1.5×ULN
* The patients were fully aware of the study, provided voluntary written informed consent, and were able to adhere to the protocol-defined visit and follow-up procedures

Exclusion Criteria:

* Patients who do not meet the requirements of lateral ventricular chemotherapy
* History of allergy to vormetinib and pemetrexed
* Severe complications occurred during the treatment
* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
* Severe infection in active stage or with poor clinical control
* Mentally ill, substance abusers and pregnant or lactating women
* No informed consent was signed
* Eligibility as judged by the other investigators

Where this trial is running

Suzhou, Jiangsu

• Nanjing Brain Hospital — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: fang S Cun, M.D.

Conditions NSCLC