Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR

Study Overview
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Brief Summary
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This study is designed to evaluate the safety and efficacy of icotinib at routine dose and higher dose as second-line treatment in non-small cell lung cancer patients with epidermal growth factor receptor of wild type.

Official Title
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An Open-label,Randomized,Controlled Study to Evaluate the Safety and Efficacy for Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Icotinib of routine dose
* Drug: Icotinib of high dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients with Histologic or cytologic confirmation. Wild type epidermal growth factor receptor status. Progressed after first-line chemotherapy. No previous systemic anticancer therapy. Measurable lesion according to response evaluation criteria in solid tumors with at least one measurable lesion not previously irradiated. Provision of written informed consent. Exclusion Criteria: Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded). Positive epidermal growth factor receptor mutation. Known severe hypersensitivity to icotinib or any of the excipients of this product. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Icotinib of routine dose<br>Icotinib: 125mg, oral administration, three times per day. | Drug: Icotinib of routine dose<br>* Icotinib: 125mg, oral administration, three times per day.<br>* Other names: BPI-2009;|
| Experimental: Icotinib of high dose<br>Icotinib: 375mg, oral administration, three times per day. | Drug: Icotinib of high dose<br>* Icotinib: 375mg, oral administration, three times per day.<br>* Other names: Conmana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, confirmed at least 28 days following the date of the initial response. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Progression free survival was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first. | 3 months | 
| Overall survival | Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive. | 14 months | 
| Number of Participants with Adverse Events | Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs. | 18 months |