Small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 80 years, no gender limit; 2. Patients with extensive-stage SCLC confirmed by histopathology or cytology; 3. Previously received second-line systemic chemotherapy failed or were intolerant to second-line system chemotherapy; 4. ECOG score: 0-1 points; 5. Expected survival time >= 3 months; 6. The investigator confirmed that there is at least one measurable lesion according to the RECIST1.1 standard; 7. The main organs are functioning normally.
Exclusion criteria
Exclusion criteria: 1. There are central tumors that invade local large blood vessels, there are obvious cavitation or necrotic tumors in the lungs; 2. Active central nervous system tumor metastasis; 3. Known to be allergic to the research drug or any of its excipients; or have a severe allergic reaction to other monoclonal antibodies; 4. Receive live attenuated vaccines within 4 weeks before the first dose or plan to receive live attenuated vaccines during the study period; 5. Immune suppressive drugs have been used within 14 days before the first use of SHR-1316; 6. There is any active autoimmune disease or a history of autoimmune disease; 7. Suffer from myocardial ischemia or myocardial infarction above grade II, or poorly controlled arrhythmia; 8. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 9. Have received major surgery within 4 weeks before the first dose; 10. Other situations that the researcher judges are not suitable for participating in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Disease Control Rate;Duration of remission; | — |
Countries
China
Contacts
Chinese Academy of Medical Sciences Cancer Hospital