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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
West China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGORR of MPE
ORR of malignant pleura effusions is the proportion of subjects with CR or PR , based on WHO Evaluation Criteria .
Time frame: Up to approximately 2 years
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).
Time frame: Up to approximately 2 years
ORR
ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.
Time frame: 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).
Time frame: 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.
Time frame: 1 year
DOR
DOR is the time between the first observed tumor responseto disease progression or relapse based on RECIST Version 1.1
Time frame: 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
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Time frame: 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.
Time frame: Up to approximately 2 years