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To evaluate the efficacy of continuing osimertinib in conjunction with metronomic oral vinorelbine after limited progression on osimertinib, to provide clinical experience on the treatment strategy for these patients.
This study is a clinical observation study. The patients who comfirm the criteria will be treated with Almonertinib plus metronomic oral vinorelbine. The patients will be followed up until the tumor progressed, and the efficacy (PFS, ORR, DCR) of tumor therapy were evaluated.
Drug administration regimen: Ametinib 110mg once a day; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Almonertinib plus metronomic oral vinorelbine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almonertinib and metronomic oral vinorelbine | Drug | Ametinib 110mg once a day; Oral Vinorelbine 40mg three times a week for three weeks and Q28d for one course. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression-free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | up to 12 months |
| DCR | Disease Control Rate | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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EGFR-mutant advanced NSCLC, disease progression on the third-generation TKI
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| ID | Term |
|---|---|
| C000718108 | aumolertinib |
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