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This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 21 icotinib (250mg) | Experimental | Patients with EGFR 21 exon positive are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 250 mg three times per day, till progressive disease or unaccepted toxicity. |
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| 21 icotinib (125mg) | Active Comparator | Patients with EGFR 21 exon positive are randomly assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity |
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| 19 icotinib (125mg) | Experimental | Patients with EGFR del 19 exon positive are assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| icotinib | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 20 months | |
| Objective response rates | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Shucai, MD | Contact | 010-89509304 | sczhang6304@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chest Hospital, Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| C531470 | icotinib |
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