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This is a phase II study. All patients are stage IV non-squamas non-small cell lung cancer(NSCLC) with malignant pleura effusion, Eastern Cooperative Oncology Group (ECOG) performance status 0-2. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy in patients with NSCLC with malignant pleura effusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-Squamous NSCLC with MPE:AK112 plus Chemotherapy | Experimental | non-Squamous NSCLC with malignant pleura effusions:Subjects receive AK112 plus Pemetrexed/Taxol and Carboplatin/Cispaltin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK112 | Drug | non-Squamous NSCLC with malignant pleura effusions:Subjects receive AK112 plus Pemetrexed and Carboplatin/Cisplatin on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK112 plus Pemetrexed until progression. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR of MPE | ORR of malignant pleura effusions is the proportion of subjects with CR or PR , based on WHO Evaluation Criteria . | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS of MPE | PFS of MPE is defined as the time from the date of randomization till the first documentation of effusion progression (per WHO criteria) assessed by the investigator or death due to any cause (whichever occurs first). | Up to approximately 2 years |
| ORR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ge Gao, PhD | Contact | 86(028)85421606 | gg1023@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongsheng Wang, Prof | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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|
ORR is the proportion of subjects with CR or PR , based on RECIST v1.1. |
| Up to approximately 2 years |
| PFS | PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first). | Up to approximately 2 years |
| OS rate of 1y | Overall survival rate of 1 year,OS is the time from the date of randomization or first dosing date to death due to any cause. | 1 year |
| DOR | DOR is the time between the first observed tumor responseto disease progression or relapse based on RECIST Version 1.1 | Up to approximately 2 years |
| DCR | DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1 | Up to approximately 2 years |
| OS | OS is the time from the date of randomization or first dosing date to death due to any cause. | Up to approximately 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |