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

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Trial Information

Inclusion Criteria:

- Histological or cytologic diagnosis of NSCLC

- Patients with disease progression after local treatment(WBRT and/or SRS) combined
with Icotinib treatment.

- Patients with EGFR mutation or the lesions that remains stable for more than 3 months
after local treatment(WBRT and/or SRS) combined with Icotinib treatment.

- ECOG performance status 0-2

- Doctors consider the patients will not benefit from local treatment(WBRT and/or SRS)

- Expected survival of greater than 3 months

- Age: 18-75 years

- The patients with key organs maintenance of basic function: Hemoglobin ≥ 9g/dL,
White Blood Cell ≥ 3×109/L, Neutrophil count ≥ 1.5×109/L, platelets ≥ 80×109/L, total
bilirubin < 1.5 times of the upper normal values, Alanine transaminase (ALT) and
aspartate transaminase (AST) < 2.5 of the upper normal values, the serum creatinine <
1.5 times of the upper normal values

- Signed informed consent document on file.

Exclusion Criteria:

- Brain metastasis without local treatment before

- Patients without the treatment of Icotinib before or the therapeutic time less than 3

- More than 3 extracranial organs have metastatic lesions

- The patient with other type malignant tumors before

- The patient with fertility capacity, but without contraceptive application

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival (intracranial lesions)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Weimin Mao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital


China: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

September 2015

Related Keywords:

  • Brain Metastases
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Brain Neoplasms