Efficacy and Safety of IBI308 and Paclitaxel/Albumin Paclitaxel for SCLC Patients Who Failed Etoposide Chemotherapy

Exclusion Criteria

• •1. Mixed lung cancer or other types of lung cancer;
• •2. Prior immunotherapy, included but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other drugs targeting T cells;
• •3. Received high-dose radiation therapy in thoracic field within the past 6 months, Dt (\> 30 Gy);
• •4. Active or untreated central nervous system (CNS) metastases;
• •6. History of autoimmune disease.Patients with a history of hypothyroidism origin autoimmune treated with a stable dose replacement therapy may be eligible for this study. Patients with controlled type 1 diabetes treated with insulin are eligible in this study;
• •7. Corticosteroid with a daily dose over 10 mg prednisolone or other immunosuppressive agents were used within 14 days before the first cycle;
• •8. Patients should not receive a vaccine during the four weeks preceding the day 1 of cycle 1, and shall not receive a vaccine during the study;
• •9. Idiopathic pulmonary fibrosis history, radioactive pneumonia requiring steroid therapy, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced lung disease, idiopathic pulmonary or active signs of pneumonia or interstitial lung infiltrate (any cause) detected on the lung scan selection;
• •10. History of active Bacillus Tuberculosis;
• •11. Except hair loss and fatigue, toxicities caused by previous anti-cancer therapies need to be restored to \< CTCAE 4.03 grade 1 before starting treatment on protocol;
• •12. History of any one or more of the following conditions within the past 6 months:symptomatic peripheral vascular disease, pulmonary embolism or untreated deep venous thrombosis (DVT), cerebrovascular accident or transient ischemic attack;
• •13. History of any one or more of the following conditions within the past 6 months: gastrointestinal ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula, tracheoesophageal fistula or abdominal abscess;
• •14. History of any one or more of the following cardiovascular conditions: Class III or IV congestive heart failure, as defined by the New York Heart Association; Unstable angina; Myocardial infarction within the past 6 months; Supraventricular or ventricular arrhythmia requires treatment or intervention;
• •15. Severe uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100mmHg);
• •16. Tumors compress surrounding vital organs, such as the esophagus, with associated symptoms;
• •17. Uncontrolled hypercalcemia;
• •18. History of allergic reactions attributed to compounds of similar chemical or biologic composition to monoclonal antibody;
• •19. Prior malignancy. Note: Patients who have had another malignancy and were treated more than 5 years ago and have since been considered cured, or patients with a history of basocellular skin carcinoma or in situ carcinoma of the uterine cervix are eligible;
• •20. Mental illness, alcoholism, inability to quit smoking, drug abuse or drug abuse;
• •21. History of human immunodeficiency virus infection or has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C Virus (HCV) (e.g., HCV RNA is detected).
• •22. Pregnant or lactating female;
• •23. Any type of systemic anticancer therapy (chemotherapy or experimental drugs) within 4 weeks of starting treatment on protocol;
• •24. Other situations judged by researchers;