Overview

Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy

Status:
Suspended
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Betta Pharmaceuticals Co.,Ltd.
Treatments:
Gefitinib
Criteria
Inclusion Criteria:

- Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV
NSCLC.

- Have been treated with gefitinib and achieved completed response, partial remission,
or stable disease within 3 months after first dose of gefitinib.

- At least one measurable lesion according to Response Evaluation Criteria in Solid
Tumors.

- Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

- Allergic to icotinib.

- Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular
compounds therapy such as erlotinib or Cetuximab.

- Severe systemic disease out of control such as unstable or uncompensated
respiratory,cardiac,liver,renal diseases.