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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Multi-center, Open Label Study to Determine the Timelines and Effeciency of Icotinib in Combination With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03754530
• Other study ID #: 2018-007-02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2018
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: Li jiancheng
• Phone: 86+13906900190
• Email: jianchengli6[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: December 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Icotinib
orally three times per day

Radiation:
• WBRT or SRS
>3 with WBRT;<=3 with SRS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival of intracranial lesions	Number of participants with progress of intracranial lesions	10 months
Secondary	Progression-free survival	Number of participants with progress of any places in body	8 months
Secondary	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	8 weeks