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

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.

Detailed Description
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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.

Official Title
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An Open, Single-Center,Single Arm Trial to Evaluate the Efficacy and Safety of Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Icotinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Icotinib<br>Icotinib will be administered 250 mg one time by month, 3 times per day. | Drug: Icotinib<br>* Icotinib will be administered 250 mg one time by month, 3 times per day.<br>* Other names: BPI-2009;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death. | 4.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival is a duration from the date that first dose is given to the date of death. | 12 months | 
| Tumor response | 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. | 6 weeks | 
| Adverse Events | Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events. | 18 months |