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The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 in subjects with locally advanced or metastatic non-small cell lung cancer; Evaluate the pharmacokinetic (PK) characteristics of HRS-4508 and other efficacy endpoints for the treatment of locally advanced or metastatic non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-4508 tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4508 tablet | Drug | HRS-4508 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0) | 2 years | |
| Objective response rate (ORR) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentrations of HRS-4508 | 12 weeks | |
| Duration of response (DoR) | 1 year | |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liju Zong | Contact | 0518-82342973 | liju.zong@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| 1 year |
| Progression free survival (PFS) | 1 year |
| Overall survival (OS) | 2 years |