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This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI939 in combination with Sintilimab | Experimental |
| |
| sintilimab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI939 | Biological | IBI939 injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | Proportion of subjects with complete response(CR) or partial response(PR). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event | 3 months | |
| Progression-free survival(PFS) | The time from randomization to the first occurrence of objective disease progression or death | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Cheng | Jilin Province Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jilin Province Cancer Hospital | Jilin City | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| Sintilimab |
| Biological |
Sintilimab injection |
|
| Overall Survival(OS) | The time from randomization to death due to any cause. | 6 months |
| Disease Control Rate(DCR) | Proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD). | 6 months |
| Duration of Response (DoR) | The time from the first documented objective tumor response(CR or PR) to objective disease progression (PD) or death. | 6 months |
| Time to Objective Response(TTR) | Time from randomization to first objective tumor response (CR or PR). | 6 months |
| Area under the plasma concentration-time curve (AUC) | 24 hours |
| Maximum concentration (Cmax) | 24 hours |
| Trough concentration (Cmin) | 24 hours |
| Clearance (CL), 12. volume of distribution (V) | 24 hours |
| Half-life (t1/2) | 24 hours |