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This study is a randomized, controlled, open-label, multicenter Phase III clinical trial designed to compare the efficacy and safety of SHR-A2009 combined with aumolertinib versus aumolertinib monotherapy in treatment-naïve subjects with EGFR-mutated, locally advanced or metastatic non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| investigational treatment group:SHR-A2009 combined with Aumolertinib | Experimental |
| |
| control group :Aumolertinib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2009 ; Aumolertinib | Drug | SHR-A2009 administered intravenously, Aumolertinib administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by BICR according to RECIST v1.1 | Up to approximately 38 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | Up to approximately 60 months | |
| Progression Free Survival(PFS by investigator) | Up to approximately 38months | |
| Duration of response(DoR,by BICR and investigator ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Liu | Contact | 0518-82342973 | jun.liu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Aumolertinib | Drug | Aumolertinib administered orally |
|
| Up to approximately 38 months |
| Disease control rate(DCR,by BICR and investigator) | Up to approximately 38 months |
| Incidence of AEs | from Day1 to 40 days after last dose |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000718108 | aumolertinib |
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