NSCLCPhase 2NCT06315686
The Dynamic Monitoring of Cerebrospinal Fluid ctDNA
A Phase 2 study testing pemetrexed in people with NSCLC, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2022to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Brain Hospital
Suzhou, Jiangsu, 210029
fang S Cun, M.D., 83728558 ext. 025, fang1984@aliyun.com
fang S cun, 83728558, fang1984@aliyun.com
About this study
Official title: A Single-center Prospective Cohort Study to Explore the Efficacy and Prognosis of Dynamic Monitoring of Cerebrospinal Fluid ctDNA
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.
- Conditions
- NSCLC
- Being tested
- pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexedDrug
Also called Furmonertinib
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The progression-free survival time（PFS）
The time from the initiation of treatment to the observation of disease progression or death from any cause.
Measured: Up to 2 years
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Occurrence and severity of AEs by NCI CTCAE v5.0
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start29 Sep 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fang S cun, M.D., Study director, Nanjing Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315686
- Sponsor's protocol ID
- MA-ENDO-202209
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Prospective Cohort Study to Explore the Efficacy and Prognosis of Dynamic Monitoring of Cerebrospinal Fluid ctDNA
- ClinicalTrials.gov ID
- NCT06315686
- Acronym / sponsor ID
- MA-ENDO-202209
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jiangsu Province Nanjing Brain HospitalUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: pemetrexedEligible patients with advanced non-small cell lung cancer with leptomeningeal metastasis were treated with vormetinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pemetrexedAlso: FurmonertinibThe 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). | Drug | Experimental group |
Primary outcome
The progression-free survival time（PFS）
Time frame: Up to 2 years
The time from the initiation of treatment to the observation of disease progression or death from any cause.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fang S cun, M.D. study director
Nanjing Brain Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pemetrexed in people with NSCLC, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fang S Cun, M.D. (83728558 ext. 025, fang1984@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The progression-free survival time（PFS） (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.