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The main purpose of this study is to evaluate the efficacy and safety of Icotinib as neoadjuvant in EGFR-mutant Stage â…¢A-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery.
Patients with EGFR-mutant Stage â…¢A-N2 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 patients with clinical benefits 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 efficacy and safety of Icotinib neoadjuvant therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib | Experimental | Patients with EGFR-mutant Stage â…¢A-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib as neoadjuvant therapy before surgery and adjuvant therapy or till progressive disease or unaccepted toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib | Drug | Patients with EGFR-mutant Stage â…¢A-N2 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 before surgery and for 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | eight weeks | |
| Disease Control Rate | eight weeks | |
| Decrease in cT-stage |
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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 |
| 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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|
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| eight weeks |
| pathologic complete remission rate | eight weeks |
| Time to Tumor Progression | five years after surgery |
| Overall survival | five years after surgery |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | five years after surgery |