Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is a Phase Ib/II study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the safety and efficacy of AK112 and AK104 with or without chemotherapy in subjects with advanced NSCLC.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK112, AK104 dose 1 plus carboplatin and paclitaxel | Experimental |
| |
| AK112, AK104 dose 1 plus carboplatin and pemetrexed | Experimental |
| |
| AK112, AK104 dose 2 plus carboplatin and paclitaxel | Experimental |
| |
| AK112, AK104 dose 2 plus carboplatin and pemetrexed | Experimental |
| |
| AK112 plus AK104 | Experimental |
| |
| AK112, AK104 plus docetaxel | Experimental |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK112 | Drug | Subjects receive AK112 intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety reflected by AE | Safety will be reflected by AE, which is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to 2 approximately years |
| ORR per RECIST v1.1 | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1. | Up to 2 approximately years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall Survival (OS) is defined as the time from the start of treatment with AK112 until death due to any cause. | Up to 2 approximately years |
| DoR per RECIST v1.1 | Duration of response (DoR) assessed according to RECIST v1.1. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China | |||
| Shanghai Pulmonary Hospital |
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D000068437 | Pemetrexed |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| docetaxel |
| Active Comparator |
|
| AK104 | Drug | Subjects receive AK104 intravenously. |
|
| Carboplatin | Drug | Subjects receive carboplatin intravenously. |
|
| paclitaxel | Drug | Subjects receive paclitaxel intravenously. |
|
| pemetrexed | Drug | Subjects receive pemetrexed intravenously. |
|
| Docetaxel | Drug | Subjects receive docetaxel intravenously. |
|
| Up to 2 approximately years |
| DCR per RECIST v1.1 | Disease control rate (DCR) assessed according to RECIST v1.1. | Up to 2 approximately years |
| TTR per RECIST v1.1 | Time to response (TTR) is defined as the time to response base on RECIST v1.1. | Up to 2 approximately years |
| PFS per RECIST v1.1 | Progression-free survival (PFS) is defined as the time from the date of Initial administration till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first). | Up to 2 approximately years |
| AK112 serum concentration | The serum concentration of AK112 of individual subjects at different time points. | Up to 2 approximately years |
| AK104 serum concentration | The serum concentration of AK104 of individual subjects at different time points. | Up to 2 approximately years |
| ADA | Number of subjects with detectable anti-drug antibodies (ADA). | Up to 2 approximately years |
| PD-L1 expression | The correlationship between PD-L1 expression and efficacy. | Up to 2 approximately years |
| ctDNA | The correlationship between ctDNA detection and efficacy. | Up to 2 approximately years |
| Shanghai |
| China |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |