Central Nervous System(CNS) Efficacy of Dacomitinib

NCT ID: NCT04675008

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2023-03-01

Brief Summary

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study arm

Dacomitinib

Group Type: EXPERIMENTAL

Dacomitinib

Intervention Type: DRUG

Secondary generation EGFR-tyrosine kinase inhibitor (TKI) (Dacomitinib) for EGFR mutant NSCLC patients with non irradiated brain metastasis

Interventions

Dacomitinib

Secondary generation EGFR-tyrosine kinase inhibitor (TKI) (Dacomitinib) for EGFR mutant NSCLC patients with non irradiated brain metastasis

Intervention Type: DRUG

Other Intervention Names

Vizimpro

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jong-Mu Sun

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jong-Mu Sun

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jong-Mu Sun, MD

Role: CONTACT

jongmu.sun@samsung.com

822-3410-1795

Facility Contacts

Jong-Mu Sun

Role: primary

jongmu.sun@skku.edu

82234103459 ext. 82234103459

Other Identifiers

SMC 2020-09-117

Identifier Type: -

Identifier Source: org_study_id