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

A Single Center, Open Label, Multicenter Study to Determine the Safety and Efficacy of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01926171

Enrollment

Registered

2013-08-20

Start date

2013-06-30

Completion date

2016-12-31

Last updated

2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small-cell Lung Cancer

Brief summary

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.

Detailed description

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 .

Interventions

DRUGIcotinib plus WBRT

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Objective response rate of intracranial lesions	8 weeks	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.

Secondary

Measure	Time frame	Description
Objective response rate of extracranial lesions	8 weeks	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.
Progression-free survival of intracranial lesions	3-6 months	All cause progress or mortality
Safety and tolerability	6-12 months	All cause adverse events (AEs) and serious adverse events (SAEs)

Countries

China

Contacts

Primary ContactWei Zhu, MD

86-18686111667

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026