A Single Center, Open Label, Multicenter Study to Determine the Safety and Efficacy of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases
Overview
- Phase
- Phase 4
- Intervention
- Icotinib plus WBRT
- Conditions
- Non-small-cell Lung Cancer
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Objective response rate of intracranial lesions
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of icotinib in combination with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is objective response rate 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 multiple 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. This study is designed to evaluate the safety and efficacy of icotinib combined with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is intracranial objective response rate .
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histological or cytological confirmation of non-small-cell lung cancer (NSCLC).
- •Diagnosis of non-systematic brain metastases on a Gadolinium-enhanced MRI. More than 2 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
- •No other metastases except for brain metastases.
Exclusion Criteria
- •Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- •CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
Arms & Interventions
Icotinib plus WBRT
Standard whole brain radiotherapy is given with 4000cGY/20 times, plus concurrent icotinib, which was administered orally three times per day.
Intervention: Icotinib plus WBRT
Outcomes
Primary Outcomes
Objective response rate of intracranial lesions
Time Frame: 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.
Secondary Outcomes
- Objective response rate of extracranial lesions(8 weeks)
- Progression-free survival of intracranial lesions(3-6 months)
- Safety and tolerability(6-12 months)