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RecruitingNCT06315686Updated Mar 18, 2024

The Dynamic Monitoring of Cerebrospinal Fluid ctDNA

A Phase 2 interventional study of pemetrexed in NSCLC, sponsored by Jiangsu Province Nanjing Brain Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by Jiangsu Province Nanjing Brain Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 5 months after the study started (first participant enrolled Sep 2022, registered Mar 2024).
  • Started Sep 2022; still recruiting 4 years later.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • NSCLC
03

In context

Lead sponsor

Jiangsu Province Nanjing Brain Hospital is the lead sponsor of 22 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Experimental group

    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

  • Drugpemetrexed

    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

06

What researchers measure

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.

    Time frame: Up to 2 years

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Occurrence and severity of AEs by NCI CTCAE v5.0

    Time frame: Up to 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06315686
Lead sponsor
Jiangsu Province Nanjing Brain Hospital
Responsible party
Sponsor
First posted
Mar 18, 2024
Start date
Sep 29, 2022
Primary completion
Jul 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Mar 18, 2024

Study contacts

fang S Cun, M.D.
Contact
fang1984@aliyun.com
83728558 ext. 025
fang S cun, M.D.
study director · Nanjing Brain Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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