Leptomeningeal MetastasisPhase 4NCT04356118
Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
A Phase 4 study testing Recombinant Human Endostatin, intrathcal methotrexate and Targeted drugs for non-small cell lung cancer in people with Leptomeningeal Metastasis, run by Hui Bu.
Trial summary
The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Metastasis
- What is being tested?
- Recombinant Human Endostatin, intrathcal methotrexate and Targeted drugs for non-small cell lung cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Jun 2023
- Phase
- Phase 4
- 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
- Age over 18 years old
- Pathologically proven non-small cell lung cancer
- Karnofsky performance status ≥ 40
- LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI .
- No severe abnormal liver and kidney function;
- Patients have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Evidence of bleeding diathesis or serious infection
- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- Pregnant or lactating women
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis
- Conditions
- Leptomeningeal Metastasis
- Being tested
- Recombinant Human Endostatin, intrathcal methotrexate, Targeted drugs for non-small cell lung cancer
- Keywords
- Recombinant Human Endostatin, Non-Small Cell Lung Cancer with Leptomeningeal Metastasis
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human EndostatinDrug
Also called Endostatin
endostatin 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles .We advocate a highly individualized treatment plan according to each patients specific manifestations of the disease process.
intrathcal methotrexateDrug
Intrathecal chemotherapy specified dose on specified days.
Targeted drugs for non-small cell lung cancerDrug
EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
| Study group | Role | What they receive |
|---|---|---|
| Endostatin Therapy for NSCLC of LM | Experimental | Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer
Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles.
intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days.
Targeted drugs for non-small cell lung cancer:
EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs . Receives: Drug: Recombinant Human Endostatin; Drug: intrathcal methotrexate; Drug: Targeted drugs for non-small cell lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leptomeningeal Metastasis Overall survival
Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up
Measured: 36 months
Neurological Progression Free Survival
From the start of treatment until central nervous system metastase progression or death due to any cause
Measured: 36 months
The incidence of adverse reactions
From date of first dose up to assessed from April 2020 to April 2023 (In accordance with the standard of CTCAE)
Measured: 36 months
Secondary outcomes (4)
Objective Response Rate
ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)
Measured: 36 months
Neurological assessment
In accordance with the standard of Response Assessment in Neuro-Oncology(RANO) Neurological Assessment group.The maximum value is 29 and the minimum value is 0.The higher scores mean a worse outcome.
Measured: 36 months
progression-free survival
Proportion of patients progression-free by investigator assessment per RECIST v1.1
Measured: 36 months
Overall survival
defined as time from Non-Small Cell Lung Cancer diagnosis to death due to any cause or last follow-up
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study startJun 2020 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal MetastasisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hui Bu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui Bu, Hebei Medical University
- Investigators
- Hui Bu, Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356118
- Sponsor's protocol ID
- BH 005
- Status last verified
- May 2020
- First submitted
- 18 Apr 2020
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
- ClinicalTrials.gov ID
- NCT04356118
- Acronym / sponsor ID
- BH 005
- Conditions
- Leptomeningeal Metastasis
- Keywords
- Recombinant Human Endostatin, Non-Small Cell Lung Cancer with Leptomeningeal Metastasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hui BuUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 22 Apr 2020 (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.
The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endostatin Therapy for NSCLC of LM | Experimental | Drug: Recombinant Human Endostatin, Drug: intrathcal methotrexate, Drug: Targeted drugs for non-small cell lung cancerRecombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles. intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days. Targeted drugs for non-small cell lung cancer: EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 years old
- Pathologically proven non-small cell lung cancer
- Karnofsky performance status ≥ 40
- LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI .
- No severe abnormal liver and kidney function;
Key exclusion criteria (3 listed)
- Evidence of bleeding diathesis or serious infection
- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- Pregnant or lactating women
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 |
|---|---|---|
| Recombinant Human EndostatinAlso: Endostatinendostatin 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles .We advocate a highly individualized treatment plan according to each patients specific manifestations of the disease process. | Drug | Endostatin Therapy for NSCLC of LM |
| intrathcal methotrexateIntrathecal chemotherapy specified dose on specified days. | Drug | Endostatin Therapy for NSCLC of LM |
| Targeted drugs for non-small cell lung cancerEGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs . | Drug | Endostatin Therapy for NSCLC of LM |
Primary outcome
Leptomeningeal Metastasis Overall survival
Time frame: 36 months
Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up
Neurological Progression Free Survival
Time frame: 36 months
From the start of treatment until central nervous system metastase progression or death due to any cause
The incidence of adverse reactions
Time frame: 36 months
From date of first dose up to assessed from April 2020 to April 2023 (In accordance with the standard of CTCAE)
4 secondary outcomes
Objective Response Rate
Time frame: 36 months
Neurological assessment
Time frame: 36 months
progression-free survival
Time frame: 36 months
Overall survival
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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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.
Hui Bu principal investigator
The Second Hospital of Hebei Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant Human Endostatin, intrathcal methotrexate and Targeted drugs for non-small cell lung cancer in people with Leptomeningeal Metastasis, run by Hui Bu.
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 3 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 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Hui Bu (86-13831106903, buhuimy1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leptomeningeal Metastasis Overall survival (time frame: 36 months). The study lists 3 primary outcomes in all. 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 27 May 2020.