Non Small Cell Lung CancerPhase 2NCT04675008
Central Nervous System(CNS) Efficacy of Dacomitinib
A Phase 2 study testing Dacomitinib in people with Non Small Cell Lung Cancer and Brain Metastases, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This is a single-arm, phase II study of dacomitinib in advanced EGFR-mutant NSCLC patients who have non-irradiated brain metastasis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Brain Metastases
- What is being tested?
- Dacomitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Dec 2020to 1 Mar 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven recurrent or metastatic NSCLC (adenocarcinoma) with major EGFR mutation (exon 19 deletion or Leu858Arg mutation without the Thr790Met)
- No prior systemic treatment of advanced NSCLC (Neoadjuvant or adjuvant chemotherapy are allowed, without limitation on its treatment timing)
- Age ≥20 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Had at least one measurable intracranial lesion as ≥ 5mm in the longest diameter by magnetic resonance imaging (MRI) (≥ 5mm by thin section (1.2mm) of brain MRI image, ≥ 10mm by less thin section(2.5mm) brain MRI ), which checked within 4 weeks before enrollment. If MRI slice thickness is not appropriate, we need to recheck Brain MRI
- Number of brain metastasis =>5
Show all 10Show fewer
- Adequate organ function
- Female subjects must either be of non-reproductive potential
- Subject is willing and able to comply with the protocol
- Signed written informed consent
Who cannot join
- Severe symptomatic brain metastasis, needing urgent control with radiotherapy or high dose steroid: the definition of high dose steroid is the equivalent dose of dexamethasone 10 mg or higher per day (mild symptoms controlled with low dose of steroid can be enrolled)
- With leptomeningeal seeding
- Exposure to EGFR-TKIs or other EGFR targeting agents at any time in either neoadjuvant or adjuvant setting
- Local treatment (stereotatic radiosurgery or whole brain radiotherapy) for brain metastases
- Uncontrolled systemic illness including uncontrolled hypertension, active bleeding, or active infection.
- Past medical history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonitis which required steroid treatment
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jong-Mu Sun
Seoul, 06351
Jong-Mu Sun, 82234103459 ext. 82234103459, jongmu.sun@skku.edu
About this study
Official title: A Phase II Study of Dacomitinib in Advanced Epidermal Growth Factor Receptor (EGFR)-Mutant Non-small Cell Lung Cancer (NSCLC) Patients Who Have Non-irradiated Brain Metastasis
This is a single-arm, phase II study of dacomitinib in advanced EGFR-mutant NSCLC patients who have non-irradiated brain metastasis.
- Conditions
- Non Small Cell Lung Cancer, Brain Metastases
- Being tested
- Dacomitinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DacomitinibDrug
Also called Vizimpro
Secondary generation EGFR-tyrosine kinase inhibitor (TKI) (Dacomitinib) for EGFR mutant NSCLC patients with non irradiated brain metastasis
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Dacomitinib Receives: Drug: Dacomitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNS objective response rate (Complete response or Partial response)
The rate of CR or PR of CNS disease
Measured: 1 year
Secondary outcomes (6)
CNS progression-free survival
Time from enrollment to CNS progression or death
Measured: 1 year
Cumulative incidence of CNS failure by competing risk analysis
To evaluate the CNS efficacy of dacomitinib
Measured: 1 year
Extracranial objective response rate
The rate of CR or PR
Measured: 1 year
Progression-free survival
Time from enrollment to progression or death
Measured: 1 year
Overall survival
Time from enrollment to death of any cause
Measured: 1 year
Safety by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
The % of side effect
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start7 Dec 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Mu Sun, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675008
- Sponsor's protocol ID
- SMC 2020-09-117
- Status last verified
- Jan 2021
- First submitted
- 15 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Dacomitinib in Advanced Epidermal Growth Factor Receptor (EGFR)-Mutant Non-small Cell Lung Cancer (NSCLC) Patients Who Have Non-irradiated Brain Metastasis
- ClinicalTrials.gov ID
- NCT04675008
- Acronym / sponsor ID
- SMC 2020-09-117
- Conditions
- Non Small Cell Lung Cancer, Brain Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 19 Dec 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.
This is a single-arm, phase II study of dacomitinib in advanced EGFR-mutant NSCLC patients who have non-irradiated brain metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: DacomitinibDacomitinib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Biopsy proven recurrent or metastatic NSCLC (adenocarcinoma) with major EGFR mutation (exon 19 deletion or Leu858Arg mutation without the Thr790Met)
- No prior systemic treatment of advanced NSCLC (Neoadjuvant or adjuvant chemotherapy are allowed, without limitation on its treatment timing)
- Age ≥20 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Had at least one measurable intracranial lesion as ≥ 5mm in the longest diameter by magnetic resonance imaging (MRI) (≥ 5mm by thin section (1.2mm) of brain MRI image, ≥ 10mm by less thin section(2.5mm) brain MRI ), which checked within 4 weeks before enrollment. If MRI slice thickness is not appropriate, we need to recheck Brain MRI
Key exclusion criteria (8 listed)
- Severe symptomatic brain metastasis, needing urgent control with radiotherapy or high dose steroid: the definition of high dose steroid is the equivalent dose of dexamethasone 10 mg or higher per day (mild symptoms controlled with low dose of steroid can be enrolled)
- With leptomeningeal seeding
- Exposure to EGFR-TKIs or other EGFR targeting agents at any time in either neoadjuvant or adjuvant setting
- Local treatment (stereotatic radiosurgery or whole brain radiotherapy) for brain metastases
- Uncontrolled systemic illness including uncontrolled hypertension, active bleeding, or active infection.
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 |
|---|---|---|
| DacomitinibAlso: VizimproSecondary generation EGFR-tyrosine kinase inhibitor (TKI) (Dacomitinib) for EGFR mutant NSCLC patients with non irradiated brain metastasis | Drug | Study arm |
Primary outcome
CNS objective response rate (Complete response or Partial response)
Time frame: 1 year
The rate of CR or PR of CNS disease
6 secondary outcomes
CNS progression-free survival
Time frame: 1 year
Cumulative incidence of CNS failure by competing risk analysis
Time frame: 1 year
Extracranial objective response rate
Time frame: 1 year
Progression-free survival
Time frame: 1 year
Overall survival
Time frame: 1 year
Safety by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
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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.
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 Dacomitinib in people with Non Small Cell Lung Cancer and Brain Metastases, run by Samsung Medical Center at 1 site in South Korea.
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 10 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 5 Jan 2021. 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 South Korea. 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 Jong-Mu Sun, MD (822-3410-1795, jongmu.sun@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNS objective response rate (Complete response or Partial response) (time frame: 1 year). 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 5 Jan 2021.