Central Nervous System(CNS) Efficacy of Dacomitinib

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.

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer; Brain Metastases
• Intervention / Treatment: Drug: Dacomitinib

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jong-Mu Sun, MD; Phone Number: 822-3410-1795; Email: jongmu.sun@samsung.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Jong-Mu Sun
    • Contact: Jong-Mu Sun; Phone Number: 82234103459 82234103459; Email: jongmu.sun@skku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm; Dacomitinib	Drug: Dacomitinib; Secondary generation EGFR-tyrosine kinase inhibitor (TKI) (Dacomitinib) for EGFR mutant NSCLC patients with non irradiated brain metastasis; Other Names: Vizimpro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CNS objective response rate (Complete response or Partial response)	The rate of CR or PR of CNS disease	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CNS progression-free survival	Time from enrollment to CNS progression or death	1 year
Cumulative incidence of CNS failure by competing risk analysis	To evaluate the CNS efficacy of dacomitinib	1 year
Extracranial objective response rate	The rate of CR or PR	1 year
Progression-free survival	Time from enrollment to progression or death	1 year
Overall survival	Time from enrollment to death of any cause	1 year
Safety by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	The % of side effect	1 year

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 1, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: SMC 2020-09-117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No