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The purpose of this study is to assess efficacy and safety of patients who receive Adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab + chemotherapy | Drug | Adebrelimab: 1200mg, d1, iv (30-60min), Q3W ,up to progressive disease or toxicity intolerable Chemotherapy: etoposide 100mg/m2,d1-3,iv;carboplatin AUC=5-6,d1,iv;or cisplatin 75mg/m2,d1,iv,Q3W,4 cycles; |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Baseline to measured date of progression or death from any cause | evaluated in 24 months since the treatment began |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Baseline to measured stable disease | tumor assessment every 6 weeks since the treatment began,up to 24 months |
| Disease control rate (DCR) | Baseline to measured progressive disease |
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Inclusion Criteria:
Exclusion Criteria:
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extensive stage small cell lung cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jun Wang | Recruiting | Shijiazhuang | Hebei | China |
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| ±chest radiotherapy | Radiation | Chest radiotherapy: 3Gy/15f-18f or 2Gy/20f-25f |
|
| tumor assessment every 6 weeks since the treatment began,up to 24 months |
| Duration of Overall Response(DoR) | The duration of overall response is measured from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented | tumor assessment every 6 weeks since the treatment began,up to 24 months |
| Overall survival (OS) | Baseline to measured date of death from any cause | the first day of treatment to death or last survival confirm date,up to 24 months |
| Adverse events | Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. The number of Participants with adverse events will be recorded at each treatment visit | up to 24 months |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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