Central Nervous System(CNS) Efficacy of Dacomitinib

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04675008
• Other study ID #: SMC 2020-09-117
• Status: Recruiting
• Phase: Phase 2
• Start date: December 7, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: January 2021
• Source: Samsung Medical Center
• Contact: Jong-Mu Sun, MD
• Phone: 822-3410-1795
• Email: jongmu.sun[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Non Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jong-Mu Sun	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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