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This is a prospective, multi-center, single-arm, phase 2 study aiming to assess the efficacy and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer (NSCLC) with positive ALK-fusion. Enrolled patients will take Ensatinib for 3 years or until recurrence of the disease or intolerable toxicity, following complete tumour resection with or without adjuvant standard chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ensartinib | Experimental | Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ensartinib | Drug | Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate (DFSR) | Defined as the percentage of patients alive and disease free at 3 years | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival rate | Defined as the percentage of patients alive at 5 years | 5 years |
| disease free survival (DFS) | Defined as the time from the date of starting treatment until the date of disease recurrence or death (by any cause in the absence of recurrence) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junfeng Liu, PhD | Contact | 13931152296 | liujf@hbmu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jun Feng Liu | Recruiting | Shijiazhuang | Hebei | 050011 | 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 |
|---|---|
| C000629294 | ensartinib |
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| Up to 5 years |
| overall survival (OS) | Defined as the time from starting treatment to death. | Up to 5 years |
| Adverse Events | The safety and tolerability profile of Ensartinib | Up to 3 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |