About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- AK112