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

Phase 2

• Conditions: Non-Small Cell Lung Cancer; Brain Metastases
• Interventions: Drug: Icotinib; Radiation: WBRT or SRS

• Registration Number: NCT03754530
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-10-31
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-26
• Last Update Submitted: 2018-11-26
• Study First Posted: 2018-11-27
• Last Update Posted: 2018-11-27
• Study Start: 2018-12-01
• Primary Completion: 2020-06-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Icotinib plus radiation therapy	Icotinib	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.
Icotinib plus radiation therapy	WBRT or SRS	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.
Icotinib	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

Primary Outcome Measures

Name	Time	Method
Progression-free survival of intracranial lesions	10 months	Number of participants with progress of intracranial lesions

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	8 months	Number of participants with progress of any places in body
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