NCT04058704

A Study to Determine the Efficiency For Brain Metastasis NSCLC Patients Treated With Icotinib Alone or Combined With Radiation Therapy

A Multi-center, Prospective Study to Determine the Efficiency of Icotinib Combined With Radiation Therapy Early Intervention or Late Intervention For NSCLC Patients With Brain Metastases and EGFR(Epidermal Growth Factor Receptor) Mutation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 296 (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 alone or in combination with radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. The primary endpoint is overall survival .

Detailed description

Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases, and most patients died due to the progression of brain metastases. Some research show that icotinib combined with radiation therapy can improve the efficiency of NSCLC with brain metastases, but there is still controversial about the timing of radiation therapy intervention . This study is a prospective, multi-center, randomized, controlled trial of icotinib combined with early intervention or late intervention radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. They will be treated with icotinib and divided into 2 groups. Group 1: the radiation therapy will start within 1 month after icotinib treatment; Group2: the patients will be treated with icotinib first, radiation therapy intervene if disease progress.

Conditions

• Non Small Cell Lung Cancer
• Brain Metastases

Interventions

Type	Name	Description
DRUG	Icotinib	125mg Tid/375mg per day
RADIATION	SRS/WBRT/HA-WBRT/SMART	\>3 with WBRT/HA-WBRT/SMART or 1-3 with SRS

Timeline

• Start date: 2018-07-20
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-08-15
• Last updated: 2019-08-15

Locations

1 site across 1 country: China