Asymptomatic Brain Metastases of Non Small Cell Lung CancerPhase 2EABMNCT02250846
Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC
A Phase 2 study testing EGFR-TKI in people with Asymptomatic Brain Metastases of Non Small Cell Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
The purpose of this study is to determine whether EGFR-TKI can control the development of intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain metastases, and the difference in progression free survival between exon 19 and exon 21 mutations. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asymptomatic Brain Metastases of Non Small Cell Lung Cancer
- What is being tested?
- EGFR-TKI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2017
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at the age of 18 -70 years old, male or female
- the non-small cell lung cancer diagnosed by histopathology
- detected by ARMS to confirm that the EGFR sensitive mutant patients
- the existence of MRI diagnosis of intracranial metastatic head enhancement, and the presence of imaging evaluating lesions (according to RECIST1.1)
- have not received prior treatment of intracranial metastases, including radiotherapy, gamma knife, chemotherapy drugs
- no brain metastasis symptoms, including, increased intracranial pressure, no vomiting, ignoring the papillary edema, no headache, without hemiplegia, ignore things not clear, without epilepsy
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- PS:0 or 1
- the expected survival time 3 months \>
- patients signed informed consent voluntarily
Who cannot join
- 4 weeks before entering the group received operation or operation, the wound has not healed completely
- into group 2 weeks before receiving immune therapy or treatment of traditional Chinese Medicine
- serious cardiovascular diseases, including Department of internal medicine, uncontrolled hypertension, unstable angina, myocardial infarction history exists within the past June, severe arrhythmia or pericardial effusion
- serious infection, need intravenous antibiotic, antifungal or antiviral treatment
- before entering the group 4 weeks participated in any study drug clinical trial
- there are serious tumor invasion, oppression by the main bronchus or bronchial stenosis or obstruction, superior vena cava syndrome
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- the existence of herniation of brain tumor apoplexy, epilepsy, and frequent
- suffering from a mental illness, poor compliance
- the researchers think that do not fit into the group of cases
About this study
Official title: Phase II Study of EGFR-TKI in Patients With EGFR Mutation Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis
The purpose of this study is to determine whether EGFR-TKI can control the development of intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain metastases, and the difference in progression free survival between exon 19 and exon 21 mutations.
Read the detailed description
A open, positive control of phase II clinical trials, divided into selection period, treatment period and follow-up period , comply with the standard set of participants signed a written informed consent, according to different divided into 19 patients with EGFR mutations outside show son mutation group) and 21 extra show mutations, and according to the ECOG physical status, age, previous systemic treatments such as hierarchical analysis, regular follow-up and to assess efficacy, life care and safety.
- Being tested
- EGFR-TKI
- Keywords
- EGFR mutations, asymptomatic brain metastases, EGFR-TKI, Erlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR-TKIDrug
egfr-TKI treatment
| Study group | Role | What they receive |
|---|---|---|
| arm a | Experimental | EGFR exon 19 mutation with EGFR-TKI Receives: Drug: EGFR-TKI |
| arm b | Experimental | EGFR exon 21 mutation with EGFR-TKI Receives: Drug: EGFR-TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial disease progression time
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Brain Metastases of Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Wu, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250846
- Sponsor's protocol ID
- WHXH-027
- Acronym
- EABM
- Status last verified
- Sep 2014
- First submitted
- 22 Sep 2014
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of EGFR-TKI in Patients With EGFR Mutation Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis
- ClinicalTrials.gov ID
- NCT02250846
- Acronym / sponsor ID
- EABM / WHXH-027
- Keywords
- EGFR mutations, asymptomatic brain metastases, EGFR-TKI, Erlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 26 Sep 2014 (estimated)
- 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 determine whether EGFR-TKI can control the development of intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain metastases, and the difference in progression free survival between exon 19 and exon 21 mutations.
Detailed description
A open, positive control of phase II clinical trials, divided into selection period, treatment period and follow-up period , comply with the standard set of participants signed a written informed consent, according to different divided into 19 patients with EGFR mutations outside show son mutation group) and 21 extra show mutations, and according to the ECOG physical status, age, previous systemic treatments such as hierarchical analysis, regular follow-up and to assess efficacy, life care and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm a | Experimental | Drug: EGFR-TKIEGFR exon 19 mutation with EGFR-TKI |
| arm b | Experimental | Drug: EGFR-TKIEGFR exon 21 mutation with EGFR-TKI |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- at the age of 18 -70 years old, male or female
- the non-small cell lung cancer diagnosed by histopathology
- detected by ARMS to confirm that the EGFR sensitive mutant patients
- the existence of MRI diagnosis of intracranial metastatic head enhancement, and the presence of imaging evaluating lesions (according to RECIST1.1)
- have not received prior treatment of intracranial metastases, including radiotherapy, gamma knife, chemotherapy drugs
Key exclusion criteria (9 listed)
- 4 weeks before entering the group received operation or operation, the wound has not healed completely
- into group 2 weeks before receiving immune therapy or treatment of traditional Chinese Medicine
- serious cardiovascular diseases, including Department of internal medicine, uncontrolled hypertension, unstable angina, myocardial infarction history exists within the past June, severe arrhythmia or pericardial effusion
- serious infection, need intravenous antibiotic, antifungal or antiviral treatment
- before entering the group 4 weeks participated in any study drug clinical trial
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 |
|---|---|---|
| EGFR-TKIegfr-TKI treatment | Drug | arm a, arm b |
Primary outcome
Intracranial disease progression time
Time frame: 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGFR-TKI in people with Asymptomatic Brain Metastases of Non Small Cell Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 9 inclusion and 9 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 26 Sep 2014. 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial disease progression time (time frame: 20 months). 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 26 Sep 2014.