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Phase II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) combined with Docetaxel in Advanced Non-Small Cell Lung Cancer whose disease has progressed after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104 plus Docetaxel | Experimental | AK104 RP2D + Docetaxel 75mg/m^2 every 3 weeks until progressive disease or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | Drug | IV infusion,Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with Adverse Events (AEs) | Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs | Up to approximately 2 years |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel |
| Drug |
IV infusion,Specified dose on specified days |
|
| Up to approximately 2 years |
| Duration of Response (DOR) | Up to approximately 2 years |
| Time to response (TTR) | Up to approximately 2 years |
| Progression free survival (PFS) | Up to approximately 2 years |
| Overall survival (OS) | Up to approximately 2 years |
| Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) Of AK104 | Up to approximately 2 years |
| Antidrug antibodies (ADA) of AK104 | Up to approximately 2 years |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |