Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation

NCT ID: NCT03754530

Last Updated: 2018-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-12-01

Brief Summary

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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

Detailed Description

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Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.

Conditions

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Non-Small Cell Lung Cancer Brain Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Icotinib

icotinib 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

Group Type EXPERIMENTAL

Icotinib

Intervention Type DRUG

orally three times per day

Icotinib plus radiation therapy

Standard 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.

Group Type EXPERIMENTAL

Icotinib

Intervention Type DRUG

orally three times per day

WBRT or SRS

Intervention Type RADIATION

\>3 with WBRT;\<=3 with SRS

Interventions

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Icotinib

orally three times per day

Intervention Type DRUG

WBRT or SRS

\>3 with WBRT;\<=3 with SRS

Intervention Type RADIATION

Other Intervention Names

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WBRT or SRS Icotinib

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li jiancheng

Role: STUDY_DIRECTOR

Fujian oncology hospital

Central Contacts

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Li jiancheng

Role: CONTACT

86+13906900190 ext. 8613906900190

Li jiancheng

Role: CONTACT

8613906900190 ext. 8613906900190

Other Identifiers

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2018-007-02

Identifier Type: -

Identifier Source: org_study_id

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