Leptomeningeal MetastasisPhase 4NCT04356222
Efficacy and Safety of Durvalumab in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
A Phase 4 study testing Durvalumab and methotrexate in people with Leptomeningeal Metastasis and Durvalumab, run by Hui Bu.
Trial summary
The purpose of this study is to observe the clinical efficacy and safety of Durvalumab combined with intrathecal chemotherapy 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, Durvalumab
- What is being tested?
- Durvalumab and methotrexate
- Type of treatment
- Injection or infusion
- 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
- Male and Female age 18 or more
- Pathologically proven non-small cell lung cancer
- MRI(Magnetic Resonance Imaging,MRI) imaging findings or the detection of malignant cells in cerebrospinal fluid
- Patients have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- KPS score <60
- History of autoimmune diseases
- With severe hepatic and renal dysfunction
- Has a history of (non-infectious) pneumonitis that required steroids
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Durvalumab Combined With Intrathecal Chemotherapy in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
The purpose of this study is to observe the clinical efficacy and safety of Durvalumab combined with intrathecal chemotherapy in non-small cell lung cancer with leptomeningeal metastasis
- Conditions
- Leptomeningeal Metastasis, Durvalumab
- Being tested
- Durvalumab, methotrexate
- Keywords
- Leptomeningeal Metastasis, Durvalumab, Intrathecal chemotherapy
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Intravenous infusion once every two weeks ,once 10mg/kg.
methotrexateDrug
Intrathecal chemotherapy specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Leptomeningeal Metastasis | Experimental | Durvalumab + Intrathecal chemotherapy Receives: Drug: Durvalumab; Drug: methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
OS was defined as the time between the start of treatment to the date of death or date participant was last known to be alive
Measured: 36 months
Neurological Progression Free Survival(NPFS)
NPFS was defined as the time between the start of treatment until central nervous system metastase progression or death due to any cause
Measured: 36 months
The incidence of adverse reactions
In accordance with the standard of CTCAE, an assessment will be assessed every 4 weeks
Measured: 36 months
Secondary outcomes (3)
Progression Free Survival(PFS)
NPFS was defined as the time between the start of treatment to the date of the first documented tumor progression as determined by investigators per RECIST 1.1,or death due to any cause
Measured: 36 months
Objective response rate (ORR)
Investigator assessed ORR was defined as the number of subjects whose best objective response (OOR) was a confirmed complete response (CR) or confirmed partial response (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
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
- NCT04356222
- Sponsor's protocol ID
- BH 004
- Status last verified
- May 2020
- First submitted
- 18 Apr 2020
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- 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 Durvalumab Combined With Intrathecal Chemotherapy in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
- ClinicalTrials.gov ID
- NCT04356222
- Acronym / sponsor ID
- BH 004
- Conditions
- Leptomeningeal Metastasis, Durvalumab
- Keywords
- Leptomeningeal Metastasis, Durvalumab, Intrathecal chemotherapy
- 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 efficacy and safety of Durvalumab combined with intrathecal chemotherapy 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 |
|---|---|---|
| Leptomeningeal Metastasis | Experimental | Drug: Durvalumab, Drug: methotrexateDurvalumab + Intrathecal chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and Female age 18 or more
- Pathologically proven non-small cell lung cancer
- MRI(Magnetic Resonance Imaging,MRI) imaging findings or the detection of malignant cells in cerebrospinal fluid
- Patients have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (4 listed)
- KPS score <60
- History of autoimmune diseases
- With severe hepatic and renal dysfunction
- Has a history of (non-infectious) pneumonitis that required steroids
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 |
|---|---|---|
| DurvalumabIntravenous infusion once every two weeks ,once 10mg/kg. | Drug | Leptomeningeal Metastasis |
| methotrexateIntrathecal chemotherapy specified dose on specified days | Drug | Leptomeningeal Metastasis |
Primary outcome
overall survival (OS)
Time frame: 36 months
OS was defined as the time between the start of treatment to the date of death or date participant was last known to be alive
Neurological Progression Free Survival(NPFS)
Time frame: 36 months
NPFS was defined as the time between 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
In accordance with the standard of CTCAE, an assessment will be assessed every 4 weeks
3 secondary outcomes
Progression Free Survival(PFS)
Time frame: 36 months
Objective response rate (ORR)
Time frame: 36 months
Neurological assessment
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.
Related trials for Leptomeningeal Metastasis
RecruitingPhase 1/2
Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
Leptomeningeal Metastasis
Active, not recruitingObservational study
SERS-Based Diagnosis of Leptomeningeal Metastasis in EGFR-Mutant NSCLC
Lung Adenocarcinoma EGFR-mutated, Leptomeningeal Metastasis From Lung Cancer
Recruiting
Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
RecruitingPhase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
Metastatic Breast Cancer, Leptomeningeal Disease
RecruitingPhase 1/2
Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
Breast Cancer
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 Durvalumab and methotrexate in people with Leptomeningeal Metastasis and Durvalumab, 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 4 inclusion and 4 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?
overall survival (OS) (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.