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

Phase 4

• Conditions: Non-small-cell Lung Cancer
• Interventions: Drug: Icotinib plus WBRT

• Registration Number: NCT01926171
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

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 .

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-20
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-14
• Last Update Posted: 2015-07-15
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib plus WBRT	Icotinib plus WBRT	Standard whole brain radiotherapy is given with 4000cGY/20 times, plus concurrent icotinib, which was administered orally three times per day.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Baotou Central Hospital; 🇨🇳 Baotou, Inner Mongolia, China