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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.


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer, Brain Metastases

Thank you

Trial Information

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.


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability

Outcome Description:

All cause adverse events (AEs) and serious adverse events (SAEs)

Outcome Time Frame:

6-12 months

Safety Issue:

Yes

Principal Investigator

You Lu

Investigator Role:

Principal Investigator

Investigator Affiliation:

West China Hospital

Authority:

China: Food and Drug Administration

Study ID:

BD-IC-IV04

NCT ID:

NCT01516983

Start Date:

December 2011

Completion Date:

September 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Brain Metastases
  • Safety
  • EGFR-TKI
  • NSCLC
  • Icotinib
  • WBRT
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms

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