Icotinib With Whole Brain Radiation Therapy in NSCLC Patients With Brain Metastases

Non-small-cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01926171
• Other study ID #: BD-IV-49
• Status: Recruiting
• Phase: Phase 4
• First received: August 16, 2013
• Last updated: July 14, 2015
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2015
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: Wei Zhu, MD
• Phone: 86-18686111667
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small-cell Lung Cancer

Intervention

Drug:
• Icotinib plus WBRT
Standard whole brain radiotherapy is given with 4000cGY/20 times, plus icotinib, which was administered orally three times per day.

Locations

Country	Name	City	State
China	Baotou Central Hospital	Baotou	Inner Mongolia

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Objective response rate of extracranial lesions	Number of participants with an objective response of extracranial lesions. 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	No
Secondary	Progression-free survival of intracranial lesions	All cause progress or mortality	3-6 months	No
Secondary	Safety and tolerability	All cause adverse events (AEs) and serious adverse events (SAEs)	6-12 months	Yes