Central Nervous System(CNS) Efficacy of Dacomitinib

Samsung Medical Center

Status and phase

Unknown

Phase 2

Conditions

Brain Metastases

Non Small Cell Lung Cancer

Treatments

Drug: Dacomitinib

Study type

Interventional

Funder types

Other

Identifiers

SMC 2020-09-117

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.