The Dynamic Monitoring of Cerebrospinal Fluid ctDNA

NCT06315686 | Recruiting Phase 2

• 1 other identifier: MA-ENDO-202209
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Up to 2 years

Study Arms (1)

Experimental group

EXPERIMENTAL

Eligible patients with advanced non-small cell lung cancer with leptomeningeal metastasis were treated with vormetinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed).

Drug: pemetrexed

Interventions

pemetrexed DRUG

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).

Also known as: Furmonertinib

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (1)

Nanjing Brain Hospital

Suzhou, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Interventions

Pemetrexed; aflutinib

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• fang S cun, M.D.

  Nanjing Brain Hospital

  STUDY DIRECTOR

Central Study Contacts

fang S Cun, M.D.

CONTACT

83728558; fang1984@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: September 29, 2022
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)