The Dynamic Monitoring of Cerebrospinal Fluid ctDNA

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06315686
• Other study ID #: MA-ENDO-202209
• Status: Recruiting
• Phase: Phase 2
• Start date: September 29, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Jiangsu Province Nanjing Brain Hospital
• Contact: fang S Cun, M.D.
• Phone: 83728558
• Email: fang1984[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Focusing on advanced EGFR mutation in NSCLC patients with leptomeningeal metastasis, vormetinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed) was used to dynamically monitor ctDNA in cerebrospinal fluid (CSF), analyze the ctDNA gene mutation profile of CSF in different patients, and explore the relationship between ctDNA and efficacy and prognosis.

Description:

This is a single-center prospective cohort study. Patients with advanced EGFR-mutated NSCLC with leptomeningeal metastasis were treated with vormetinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed). Dynamic monitoring of cerebrospinal fluid ctDNA was performed to analyze the ctDNA gene mutation profile of cerebrospinal fluid in different patients, and to explore the relationship between ctDNA and efficacy and prognosis. At the same time, the study of drug vacation in the treatment of leptomeningeal metastasis is to explore the efficacy and safety of brain drug vacation, so as to reduce the patient's tolerance to drugs and the side effects of drugs. The endpoint was progression-free survival (PFS) of intracranial lesions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• pemetrexed
The efficacy of Furmonertinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed) was evaluated once a week during the treatment phase. After the brain lesions were evaluated as CR, the drug holiday study phase was added. During the study period, the patients were followed up once a week until the investigators deemed the subjects unfit to continue to participate in the study or the efficacy was evaluated as disease progression (PD).

Locations

Country	Name	City	State
China	Nanjing Brain Hospital	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Province Nanjing Brain Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The progression-free survival time(PFS)	The time from the initiation of treatment to the observation of disease progression or death from any cause.	Up to 2 years
Secondary	Incidence of Treatment-Emergent Adverse Events	Occurrence and severity of AEs by NCI CTCAE v5.0	Up to 2 years