Leptomeningeal MetastasisPhase 2NCT04833205
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer
A Phase 2 study testing Nimotuzumab in people with Leptomeningeal Metastasis and Lung Cancer, run by Hui Bu at 2 sites in China.
Trial summary
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Metastasis, Lung Cancer
- What is being tested?
- Nimotuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 19 Apr 2021to 19 Apr 2023
- 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
- age 18 years or older, gender not limited;
- A definite diagnosis of Leptomeningeal metastases from lung cancer, including cerebrospinal fluid cytology and/or neuroimaging;
- Have a clear history of lung cancer, including histopathological diagnosis, or cytopathology combined with imaging diagnosis
- Patients who received any of EGFR inhibitors (gefitinib, erlotinib, afatinib, osimertinib etc.) meet the diagnostic criteria for secondary resistance and were in a slow progression stage
- Detection results of cerebrospinal fluid, blood gene or lung tissue specimens showed EGFR mutation, and immunohistochemistry results of cerebrospinal fluid, blood gene or lung tissue showed positive EGFR expression
- Bone marrow, liver, kidneys and blood clotting function are relatively stable
Who cannot join
- Eastern Cooperative Oncology Group scored > 2 points
- Patients had poor compliance, or for other reasons the investigator considered them unsuitable to participate in the study
Trial locations and contacts
2 sites in 1 country.
jiao xue qi, master contact
China2 sites, 2 recruiting
- Recruiting
The Second Hospital of Hebei Medical University
Hebei, Shijiazhuang/hebei, 050000
hui bu, phd, 13831106903, buhuimy1@163.com
- Recruiting
The Second Hospital of Hebei Medical University
Hebei
hui bu, phD, 13831106903, buhuimy1@163.com
About this study
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer.
- Conditions
- Leptomeningeal Metastasis, Lung Cancer
- Being tested
- Nimotuzumab
- Keywords
- Leptomeningeal Metastasis, ,Nimotuzumab, Lung Cancer, EGFR-TKI
- Medical subject headings
- Meningeal Carcinomatosis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Also called EGFR-TKI
Nimotuzumab 200 mg was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping, the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Leptomeningeal metastases received EGFR-TKI and Nimotuzumab | Experimental | The patients received Nimotuzumab 200 mg,which was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping.And the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks.One the other hand,the patient received the third generation of EGFR-TKI Receives: Drug: Nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
From the diagnosis of the LM to the time of disease worsen
Measured: 2 years
Secondary outcomes (2)
Overall Survival
From the diagnosis of theLM to the time of death
Measured: 2 years
Incidence of Treatment-Emergent Adverse Events
When the Nimotuzumab is used,we will observe if the patients have the allergic reaction,diarrhea ,vomiting and so on.Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
Measured: 8Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start19 Apr 2021 (estimated)
- Primary completion19 Apr 2022 (estimated)
- Study completion19 Apr 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 2
- 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
- jiao xue qi, master, Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833205
- Sponsor's protocol ID
- BH005
- Status last verified
- Apr 2021
- First submitted
- 1 Mar 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer
- ClinicalTrials.gov ID
- NCT04833205
- Acronym / sponsor ID
- BH005
- Conditions
- Leptomeningeal Metastasis, Lung Cancer
- Keywords
- Leptomeningeal Metastasis, ,Nimotuzumab, Lung Cancer, EGFR-TKI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hui BuUniversity, hospital or other
- Study start
- 19 Apr 2021 (estimated)
- Primary completion
- 19 Apr 2022 (estimated)
- Study completion
- 19 Apr 2023 (estimated)
- First posted
- 6 Apr 2021 (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.
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leptomeningeal metastases received EGFR-TKI and Nimotuzumab | Experimental | Drug: NimotuzumabThe patients received Nimotuzumab 200 mg,which was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping.And the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks.One the other hand,the patient received the third generation of EGFR-TKI |
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 18 years or older, gender not limited;
- A definite diagnosis of Leptomeningeal metastases from lung cancer, including cerebrospinal fluid cytology and/or neuroimaging;
- Have a clear history of lung cancer, including histopathological diagnosis, or cytopathology combined with imaging diagnosis
- Patients who received any of EGFR inhibitors (gefitinib, erlotinib, afatinib, osimertinib etc.) meet the diagnostic criteria for secondary resistance and were in a slow progression stage
- Detection results of cerebrospinal fluid, blood gene or lung tissue specimens showed EGFR mutation, and immunohistochemistry results of cerebrospinal fluid, blood gene or lung tissue showed positive EGFR expression
Key exclusion criteria (2 listed)
- Eastern Cooperative Oncology Group scored > 2 points
- Patients had poor compliance, or for other reasons the investigator considered them unsuitable to participate in the study
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 |
|---|---|---|
| NimotuzumabAlso: EGFR-TKINimotuzumab 200 mg was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping, the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks | Drug | Leptomeningeal metastases received EGFR-TKI and Nimotuzumab |
Primary outcome
progression free survival
Time frame: 2 years
From the diagnosis of the LM to the time of disease worsen
2 secondary outcomes
Overall Survival
Time frame: 2 years
Incidence of Treatment-Emergent Adverse Events
Time frame: 8Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- 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.
jiao xue qi, master contact
jiao xue qi, master principal investigator
The Second Hospital of Hebei Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab in people with Leptomeningeal Metastasis and Lung Cancer, run by Hui Bu at 2 sites 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 2 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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 hui bu, PhD (0311-66003711-211, buhuimy1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 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 20 Apr 2021.