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

Betta Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Brain Metastases; Non-small Cell Lung Cancer

Treatments: Drug: icotinib; Radiation: Whole brain radiotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01516983

BD-IC-IV04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 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 brain metastases on a Gadolinium-enhanced MRI. More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
• Positive EGFR mutation.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Icotinib+WBRT

Experimental group

Description:

Standard whole brain radiotherapy plus icotinib, which is designed to administered at 5 dose according to "3+3" until disease progression or intolerable toxicity.

Treatment:

Radiation: Whole brain radiotherapy

Drug: icotinib