High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease

Study Overview
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Brief Summary
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We hypothesize that higher dose icotinib is related with better efficacy. The primary objective is to compare the progression-free survival of higher dose and routine dose of icotinib in treating pretreated advanced non-small cell lung cancer patients with stable disease after 8-week routine dose icotinib treatment.

Official Title
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High Dose Versus Routine Dose Icotinib in Pretreated Non-small Cell Lung Cancer Patients With Stable Disease: a Phase II Randomized Study

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Routine dose icotinib
* Drug: Higher dose icotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology); Pretreated with at least 1 platinum-based chemotherapy; No previous targeted treatment such as gefitinib, erlotinib; With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria; WHO performance status(PS)<= 2; Adequate organ functions; Signed and dated informed consent before the start of specific protocol procedures. Exclusion Criteria: Allergic to icotinib; Patients with metastatic brain tumors with symptoms; Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, 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: 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 |
| --- | --- |
| Experimental: Higher dose icotinib<br>Patients with stable disease after 8-week routine dose icotinib treatment, are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 375 mg three times per day, till progressive disease or unaccepted toxicity. | Drug: Higher dose icotinib<br>* After 8-week induction of icotinib with a dose of 125 mg three times daily, icotinib is administered 375 mg three times per day.<br>* Other names: Commana;|
| Active Comparator: Routine dose icotinib<br>Patients with stable disease after 8-week routine dose icotinib treatment, are administered with icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity. | Drug: Routine dose icotinib<br>* Icotinib is administered 125 mg three times daily.<br>* Other names: Commana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 18 months | 
| Response rate assessed using the RECIST criteria |  | 2 months | 
| The number of patients who suffered adverse events | Adverse events are assessed by Common Terminology Criteria for Adverse Events v4.0 | 30 months |