A Phase II Study of AK112 (PD-1/VEGF Bispecific) in Combination with Chemotherapy for Patients with Advanced Non-squamas Non-mall Cell Lung Cancer and Malignant Pleural Effusion
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；
• Have a life expectancy of at least 3 months；
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2；
• Has adequate organ function；
• Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator；
• Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy；
• All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment；
• Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).