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This study is a phase Ib/III clinical study to evaluate the efficacy and safety of recombinant fully human anti-programmed cell death receptor 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) bispecific antibody injection (IBI318) in combination with paclitaxel versus placebo in combination with paclitaxel in subjects with small cell lung cancer who have failed first-line or above chemotherapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI318 in combination with paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel | Drug | 80mg/m^2,iv,Q4W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | The incidence rate of all treatment-emergent adverse events (TEAEs), immune-related adverse events (irAEs) and serious adverse events (SAEs), treatment-related adverse events (TRAEs) and the severity. | 3 months |
| Objective remission rate | Proportion of subjects with complete response (CR) or partial response (PR). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous remission time (DOR) | For subjects with CR or PR, it is defined as the time from the first documented objective tumor response (CR or PR) to objective disease progression (PD) or death. | 12 months |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Cheng, Ph.D | Jilin Povince Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jilin Povince Cancer Hospital | Changchun | Jilin | China |
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| IBI318 |
| Drug |
300mg,iv,Q4W |
|
Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD).
| 12 months |
| Time to response (TTR) | Time from randomization to first objective tumor response (CR or PR). | 12 months |
| Progression-free survival (PFS) | Defined as the time from randomization to the first occurrence of objective disease progression or death. | 12 months |
| Overall survival (OS) | Defined as the time from randomization to death due to any cause. | 12 months |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| 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 |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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