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Evaluate the safety, tolerability, and objective response rate (ORR) of SHR2554 tablets in combination with other anti-tumor treatments in subjects with locally advanced or metastatic non-small cell lung cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Queue A | Experimental |
| |
| Queue B | Experimental |
| |
| Queue C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR2554; SHR-A2102 | Drug | SHR2554 tablets combined with SHR-A2102 for injection, with a cycle of 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | 21days after the first administration of each subject | |
| AE | from Day1 to 30 days after last dose | |
| Incidence and severity of serious adverse events (SAE) | from Day1 to 30 days after last dose | |
| ORR | from first dose to disease progression or death, whichever comes first, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenic indicators: anti-SHR-A2102 antibody (ADA) | through study completion, an average of 2 years | |
| Duration of response (DoR) | from first dose to disease progression or death, whichever comes first, up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoxue Pi | Contact | 0518-82342973 | Xiaoxue.pi@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| SHR2554; Adabelimumab | Drug | SHR2554 tablets combined with Adabelimumab, with a cycle of 21 days |
|
| SHR2554; SHR-1701 | Drug | SHR2554 tablets combined with SHR-1701 injection, with a cycle of 21 days |
|
| disease control rate (DCR) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| progression free survival (PFS) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| overall survival (OS) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| 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 |
|---|---|
| C000723862 | SHR-1701 |
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