NCT03754530

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer
• Brain Metastases

Interventions

Type	Name	Description
DRUG	Icotinib	orally three times per day
RADIATION	WBRT or SRS	\>3 with WBRT;\<=3 with SRS

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-06-01
• Completion: 2021-12-01
• First posted: 2018-11-27
• Last updated: 2018-11-27