A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC

Inclusion Criteria:

• 18 to 75 years old (at the time of inform consent obtained)；

• Have histologically- or cytologically-confirmed diagnosis of Stage IV non-squamasNSCLC；

• The presence of malignant pleural effusion (positive pleural effusion cytology ormultiple 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 obtainedfrom either a core or excisional tumor biopsy；

• All female and male subjects of reproductive potential must agree to use aneffective 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 allrequirements of study participation (including all study procedures).

Exclusion Criteria:

• Histological or cytological pathology confirmed the presence of small cell carcinomacomponents, or the main component is squamous cell carcinoma；

• Active malignancies within the past 3 years, with the exception of tumors in thisstudy and cured local tumors；

• Is currently participating in a study of an investigational agent or using aninvestigational device;

• Active autoimmune disease requiring systemic treatment within 2 years prior to thestart of study treatment；

• Subjects who received any prior treatments targeting VEGFR;

• Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected);

• History of myocardial infarction, unstable angina, cardiac or other vascularstenting, angioplasty, or surgery within 12 months prior to day 1 of studytreatment;

• Has undergone major surgery within 30 days prior to the first dose of studytreatment;

• Has an active autoimmune disease that has required systemic treatment in the past 2years (i.e. with use of disease modifying agents, corticosteroids orimmunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin orphysiologic corticosteroid replacement therapy for adrenal or pituitaryinsufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjectswith vitiligo or resolved childhood asthma/atopy would be an exception to this rule.Subjects that require intermittent use of bronchodilators or local steroidinjections would not be excluded from the study;

• Has received a live virus vaccine within 30 days prior to first dose of studytreatment；