Evaluate the Efficacy and Safety of IBI305 in Patients With Advanced or Recurrent Non-squamous NSCLC

Inclusion Criteria

• signed inform consent form(ICF)
• Age ≥ 18 years and ≤ 75 years, male or female
• Histologically or cytologically documented inoperable, local advanced (stage IIIB), metastatic (stage IV), or recurrent non-squamous NSCLC; Mixed tumors should be categorized according to the predominant cell type
• Histologically confirmed epidermal growth factor receptor (EGFR) wild type or insensitive mutation
• At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
• Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
• Life expectancy ≥ 6 months
• Laboratory results:
• Adequate hematologic function, defined as absolute neutrophil count ≥1.5×10^9 /L, platelet count ≥100 ×10^9 /L, hemoglobin ≥90g/L;
• Adequate liver function, defined as total bilirubin levels ≤ 1.5 times normal upper limit (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN, or AST and ALT levels ≤ 5 times ULN for patients with hepatic metastasis;
• Adequate renal function, defined as serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 50 ml / min (Cockcroft-Gault formula) and proteinuria 325 mg/day) or other non-steroidal anti-inflammatory drugs (NSAID) known to inhibit platelet function (within 10 days prior to first dose of study treatment)
• Recent or current receive treatment of oral all doses of oral or parenteral anticoagulants or thrombolytic agent. Prophylactic use of anticoagulants is permitted.
• History or evidence of inherited bleeding diathesis or coagulopathy or thrombus
• Uncontrolled hypertension (SBP>140 mmHg and/or diastolic blood pressure>90 mmHg), prior history of hypertensive crisis and hypertensive encephalopathy
• Clinically significant cardiovascular disease but not limited to active infections; unstable angina; stroke or transient cerebral ischemia (within 6 months prior to screening); myocardial infarction (within 6 months prior to screening) ; congestive heart-failure (New York Heart Association (NYHA) class≥ II) ; serious cardiac arrhythmia, hepatic, renal or metabolic disease requiring medication during the study.
• History of peptic ulcer, gastrointestinal perforation, erosive esophagitis, erosive gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula or intra-abdominal abscess within 6 months prior to screening
• Patient diagnosed with a tracheo-esophageal fistula
• Clinically significant third space effusion (e.g., uncontrolled ascites or pleural effusion by extraction or other treatment)
• Pulmonary fibrosis or active pneumonia showed by CT at baseline
• Active malignancy other than non-small cell lung cancer (NSCLC), treated carcinoma in situ of the cervix, superficial basal cell or squamous cell carcinoma, radical surgery of localized prostate cancer, radical surgery of ductal carcinoma in situ within 5 years prior to randomization
• Known autoimmune disease
• Known positive HbsAg and hepatitis B virus (HBV)-DNA drop test in peripheral blood ≥ 1 x 10^3 copy number/L or 200 IU/mL; If HBsAg positive and HBV-DNA drop test in peripheral blood < 1 x 10^3 copy number/L or 200 IU/mL, patient is considered to be eligible by investigator only when chronic hepatitis B in the plateau and do not increase the risk
• Known positive HIV or hepatitis C virus (HCV) or syphilis
• Known allergic disease or allergic physique
• Treatment with any other investigational agent or participation in another clinical trial within 30 days prior to screening
• Known alcoholism or drug abuse
• Pregnant or anticipation of pregnant during the study or lactating women
• Known hypersensitivity to bevacizumab or any of its excipients and/or any of the chemotherapy agents
• Other conditions that the investigator thinks unsuitable in this study