IBI310 (Anti-CTLA-4) in Combination With Sintilimab in Patients With Non-small-cell Lung Cancer (NSCLC)

Eligibility Criteria:

• Aged ≥18 years;
• ECOG 0 ~ 1;
• Histologically /cytologically confirmed R/M NSCLC;
• Adequate organ and bone marrow function;
• Expected survival ≥12 weeks;
• Female subjects of childbearing age or male patients whose sex partners are women of childbearing age should take effective contraceptive measures throughout the treatment period and within 6 months after the last administration;
• Subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol.
• At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).

Exclusion criteria

• Had tumors other than NSCLC within the past 5 years.
• Had allogeneic organ or stem cell transplantation.
• The presence of uncontrolled life-threatening illness
• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
• Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
• HIV positive.
• Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
• Severe, uncontrolled medical conditions and infections.
• At the same time using other test drugs or in other clinical trials.
• Refusal or inability to sign informed consent to participate in the trial.
• Other treatment contraindications.
• Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
• Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
• Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.