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.
18 to 75 years old (at the time of inform consent obtained)；
Have histologically- or cytologically-confirmed diagnosis of Stage IV non-squamas NSCLC；
The presence of malignant pleural effusion (positive pleural effusion cytology or multiple pleural nodules or thickening with pleural effusion on CT imaging)；
Driver gene mutation negative；
Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinoma；
Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors；
Is currently participating in a study of an investigational agent or using an investigational device;
Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment；
Single group
AK112
Drugnon-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.
ORR of MPE
ORR of malignant pleura effusions is the proportion of subjects with CR or PR , based on WHO Evaluation Criteria .
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).
ORR
ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.
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).
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.
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