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This study is a single-arm, open-label, multicenter phase II clinical trial aimed at evaluating the efficacy, safety, and pharmacokinetics of SHR-1826 in treating locally advanced or metastatic non-small cell lung cancer . The recommended dose of SHR-1826 was administered via intravenous infusion once every 3 weeks (Q3W), with each treatment cycle lasting 21 days until meeting protocol-defined treatment discontinuation criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1826 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1826 | Drug | SHR-1826 |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR assessed by IRC according to RECIST v1.1 s) | once every 6 weeks, estimated 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1; | once every 6 weeks, estimated 2 years | |
| Disease Control Rate (DCR) assessed by the IRC and investigator according to RECIST v1.1; | once every 6 weeks, estimated 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yijun Jia | Contact | +0518-81220121 | Yijun.jia@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | 250117 | 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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| Duration of Response (DoR) assessed by the IRC and investigator according to RECIST v1.1; | once every 6 weeks, estimated 2 years |
| Progression-Free Survival (PFS) assessed by the IRC and investigator according to RECIST v1.1; | Estimated 2 years |
| Overall Survival (OS). | Estimated 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |