Icotinib With Whole Brain Radiation Therapy in NSCLC Patients With Brain Metastases

Phase 4UnknownNCT01926171

Betta Pharmaceuticals Co., Ltd.80 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of icotinib in combination with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is objective response rate of intracranial lesions.

Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with multiple 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. This study is designed to evaluate the safety and efficacy of icotinib combined with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is intracranial objective response rate .

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-small-cell Lung Cancer

Interventions

Icotinib plus WBRTDRUG

Standard whole brain radiotherapy is given with 4000cGY/20 times, plus icotinib, which was administered orally three times per day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histological or cytological confirmation of non-small-cell lung cancer (NSCLC). * Diagnosis of non-systematic brain metastases on a Gadolinium-enhanced MRI. More than 2 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm. * No other metastases except for brain metastases. Exclusion Criteria: * Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux. * CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.

Locations (1)

Baotou Central Hospital

Baotou, Inner Mongolia, China

RECRUITING

Outcomes

Primary Outcomes

Objective response rate of intracranial lesions

Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.

Time frame: 8 weeks

Secondary Outcomes

Objective response rate of extracranial lesions

Number of participants with an objective response of extracranial lesions. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.

Time frame: 8 weeks

Progression-free survival of intracranial lesions

All cause progress or mortality

Time frame: 3-6 months

Safety and tolerability

All cause adverse events (AEs) and serious adverse events (SAEs)

Time frame: 6-12 months

Central Contacts

Wei Zhu, MD

CONTACT

86-18686111667

Data from ClinicalTrials.gov

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