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This study was a randomized, controlled, open-label, multicenter phase III clinical study to compare the efficacy and safety of SHR-A2009 with platinum-based dual-agent chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer who failed EGFR TKI treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A2009 monotherapy | Experimental |
| |
| platinum-based dual-agent chemotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2009 monotherapy | Drug | SHR-A2009 monotherapy ,SHR-A2009 will be administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by BICR according to RECIST v1.1 | Up to approximately 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | Up to approximately 32 months | |
| Progression Free Survival(PFS by investigator) | Up to approximately 32 months | |
| Duration of response(DoR,by BICR and investigator ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510000 | 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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| platinum-based dual-agent chemotherapy | Drug | Pemetrexed combined with carboplatin or cisplatin, after four cycles of combination, pemetrexed was continued as a single agent,all drugs will be administered intravenously |
|
| Up to approximately 32 months |
| Disease control rate(DCR,by BICR and investigator) | Up to approximately 32 months |
| Incidence of AEs | from Day1 to 40 days after last dose |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |