Clinical trial NCT04675008: Central Nervous System(CNS) Efficacy of Dacomitinib
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Brain Metastases
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, phase II study of dacomitinib in advanced EGFR-mutant NSCLC patients who have non-irradiated brain metastasis.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: CNS objective response rate (Complete response or Partial response)
timeFrame: 1 year
Secondary outcomes:
measure: CNS progression-free survival
timeFrame: 1 year
measure: Cumulative incidence of CNS failure by competing risk analysis
timeFrame: 1 year
measure: Extracranial objective response rate
timeFrame: 1 year
measure: Progression-free survival
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
measure: Safety by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jong-Mu Sun
Study officials:
References: