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The main purpose of this study is to evaluate the pulmonary and metastases lesions objective response rate after Icotinib preoperative therapy in EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery.
Patients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks as neoadjuvant therapy; then they receive surgical resection of the tumor. If there is curative effect of Icotinib according to the RECIST or pathological report, the patients will continue receive Icotinib for two years as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity. The primary objective of this study is evaluate the pulmonary and metastases lesions objective response rate after Icotinib preoperative therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib | Experimental | Patients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks before surgery and 2 years as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib | Drug | Patients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day by mouth for 8 weeks as neoadjuvant therapy before surgery and 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate as assessed by RECIST1.1 | Objective Response Rate was defined as the percentage of participants whose tumor lesions disappear completely or diameters reduced by at least 30% as assessed by RECIST1.1. | eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate as assessed by RECIST1.1 | Disease Control Rate was defined as the total percentage of participants except for those with tumor lesions diameters increased by at least 20% as assessed by RECIST1.1. | five years after surgery |
| Time to Tumor Progression as assessed by RECIST1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shugeng Gao, MD | Contact | 13801185056 | gaoshugeng@vip.sina.com | |
| Feiyue Feng | Contact | 13693532206 | feiyuefeng_cn@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Shugeng Gao | Cancer Hospital Chinese Academy of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Science | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| C531470 | icotinib |
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Time to Tumor Progression was defined as the time between participants' randomization and their tumor progression as assessed by RECIST1.1. |
| five years after surgery |
| Overall survival of participants | Overall survival was defined as the time from participants' randomization to their death due to any cause. | five years after surgery |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | The number of participants with treatment-related adverse events as assessed by CTCAE v4.0 would be recorded and calculated after them participating into the study and taking the experimental drug. | five years after surgery |