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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Higher dose icotinib | Experimental | 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. |
|
| Routine dose icotinib | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine dose icotinib | Drug | Icotinib is administered 125 mg three times daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 5 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shun Lu, MD | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C531470 | icotinib |
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| Higher dose icotinib | Drug | After 8-week induction of icotinib with a dose of 125 mg three times daily, icotinib is administered 375 mg three times per day. |
|
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Adverse events are assessed by Common Terminology Criteria for Adverse Events v4.0 |
| 30 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |