Clinical trial

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

Name

MA-ENDO-202209

Description

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.

Trial arms

Trial start

2022-09-29

Estimated PCD

2024-07-31

Trial end

2024-12-31

Status

Recruiting

Phase

Early phase I

Treatment

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).

Arms:

Experimental group

Other names:

Furmonertinib

Size

Primary endpoint

The progression-free survival time（PFS）

Up to 2 years

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-03-18

1 organization

1 drug

1 indication

Organization

Jiangsu Province Nanjing Brain Hospital

Drug

pemetrexed

Indication

NSCLC