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This study is a multicenter, open label phase I clinical trial aimed at evaluating the pharmacokinetics, tolerability, safety and immunogenicity of SHR-1316 (sc) subcutaneous administration combined with carboplatin and etoposide as first-line treatment for extensive stage small cell lung cancer, and to observe the initial anti-tumor efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1316 (sc) Dose A Group | Experimental |
| |
| SHR-1316 (sc) Dose B Group | Experimental |
| |
| SHR-1316 (sc) Dose C Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1316 (sc) Injection | Drug | SHR-1316 (sc) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SHR-1316 serum trough concentration (Ctrough) | Day1 pre-dose to Day28. | |
| Area under the concentration curve from time 0 to 21 days for SHR-1316 (sc) (AUC0-21d) | Day1 pre-dose to Day21. | |
| Area under the concentration curve from time 0 to 28 days for SHR-1316 (sc) (AUC0-28d) | Day1 pre-dose to Day28. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration of SHR-1316 (sc) (Cmax) | Day1 pre-dose to Day28. | |
| Time to maximum plasma concentration (Tmax) | Day1 pre-dose to Day28. | |
| Terminal half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330200 | China |
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| SHR-1316 Injection | Drug | SHR-1316 injection. |
|
| Carboplatin Injection | Drug | Carboplatin injection. |
|
| Etoposide Injection | Drug | Etoposide injection. |
|
| Day1 pre-dose to Day28. |
| Incidence and severity of adverse events (AEs) | About 2 years. |
| Objective Response Rate (ORR) | About 2 years. |
| Duration of Relief (DoR) | About 1.5 years. |
| Disease Control Rate (DCR) | About 2 years. |
| Progression-free Survival (PFS) | About 2 years. |
| Overall Survival (OS) | About 3 years. |
| ID | Term |
|---|---|
| D007267 | Injections |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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