Central Nervous System(CNS) Efficacy of Dacomitinib

NCT04675008 | Unknown Phase 2

• 1 other identifier: SMC 2020-09-117
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• CNS objective response rate (Complete response or Partial response)

  The rate of CR or PR of CNS disease

  1 year

Secondary Outcomes (6)

• CNS progression-free survival

  1 year

• Cumulative incidence of CNS failure by competing risk analysis

  1 year

• Extracranial objective response rate

  1 year

• Progression-free survival

  1 year

• Overall survival

  1 year

Study Arms (1)

Study arm

EXPERIMENTAL

Dacomitinib

Drug: Dacomitinib

Interventions

Dacomitinib DRUG

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

Also known as: Vizimpro

Study arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Jong-Mu Sun

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

dacomitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jong-Mu Sun, MD

CONTACT

822-3410-1795; jongmu.sun@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 19, 2020
• Study Start: December 7, 2020
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

KR (1)