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

Betta Pharmaceuticals

Status and phase

Unknown

Phase 4

Conditions

Non-small-cell Lung Cancer

Treatments

Drug: Icotinib plus WBRT

Study type

Interventional

Funder types

Industry

Identifiers

NCT01926171

BD-IV-49

Details and patient eligibility

About

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.

Full 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 .

Enrollment

80 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.