Non-small Cell Lung Cancer
Conditions
Brief summary
To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.
Detailed description
This single center, single arm open label study is designed to assess the safety and efficacy of using high dose of Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that progressed after routine gefitinib therapy by progression-free survival, as well as overall survival and disease control rate. The adverse events and adverse reaction are evaluated as well.
Interventions
DRUGIcotinib
Icotinib will be administered 250 mg one time by month, 3 times per day.
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 4.5 months | Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 12 months | Overall survival is a duration from the date that first dose is given to the date of death. |
| Tumor response | 6 weeks | Tumor response is designed by imaging according to Response Evaluation Criteria in Solid Tumors, including complete response, partial remission, stable disease as well as progressed disease. |
| Adverse Events | 18 months | Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events. |
Countries
China
Outcome results
None listed