Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
A Multi-center, Open Label Study to Determine the Timelines and Effeciency of Icotinib in Combination With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
1 other identifier
interventional
162
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS of intracranial lesions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Dec 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 27, 2018
November 1, 2018
1.5 years
October 31, 2018
November 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival of intracranial lesions
Number of participants with progress of intracranial lesions
10 months
Secondary Outcomes (2)
Progression-free survival
8 months
Objective response rate of intracranial lesions
8 weeks
Study Arms (2)
Icotinib
EXPERIMENTALicotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(\>3 with WBRT or \<=3 with SRS) after PD
Icotinib plus radiation therapy
EXPERIMENTALStandard whole brain radiotherapy (WBRT) is given with 30GY/10 times(\>3), or SRS(\<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses.
Interventions
orally three times per day
\>3 with WBRT;\<=3 with SRS
Eligibility Criteria
You may qualify if:
- Histological or cytological confirmation of non-small-cell lung cancer (NSCLC) with brain metastases
- Histological or cytological confirmation of EGRF positive sensitive mutation
- Diagnosis of brain metastases on a Gadolinium-enhanced MRI
You may not qualify if:
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux
- Previous usage of radiation with brain
- CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Li jiancheng
Fujian oncology hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2018
First Posted
November 27, 2018
Study Start
December 1, 2018
Primary Completion
June 1, 2020
Study Completion
December 1, 2021
Last Updated
November 27, 2018
Record last verified: 2018-11