NCT01516983

Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation

A Single Center, Open Label, Dose-Finding Study to Determine the Safety of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• 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 safety and tolerability of Icotinib at different dose levels in combination with whole brain radiotherapy for NSCLC patients with brain metastases and EGFR mutation.

Detailed description

The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival improvement around 3-6 months. EGFR-TKIs like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits in such patients.

Conditions

• Non-small Cell Lung Cancer
• Brain Metastases

Interventions

Type	Name	Description
DRUG	icotinib	Level 1: Standard whole brain radiation therapy plus icotinib 125 mg Tid (375 mg per day) from day1 until disease progression or intolerable toxicity. Level 2: Standard whole brain radiation therapy plus icotinib 250 mg Tid (750 mg per day) from day1 until disease progression or intolerable toxicity. Level 3: Standard whole brain radiation therapy plus icotinib 375 mg Tid (1125 mg per day) from day1 until disease progression or intolerable toxicity. Level 4:Standard whole brain radiation therapy plus icotinib 500 mg Tid (1500 mg per day) from day1 until disease progression or intolerable toxicity.
RADIATION	Whole brain radiotherapy	Whole Brain Radiation Therapy (WBRT) for total dose of 37.5Gy in 15 daily fractions beginning after Day 7.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2012-01-25
• Last updated: 2014-02-17

Locations

1 site across 1 country: China