Lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age at least 18 years. 2. Documented evidence of NSCLC (locally advanced, unresectable, Stage III/IVa). 3. World Health Organisation (WHO) Performance Status of 0 to 1. 4. Estimated life expectancy of more than 3 months. 5. All patients must provide written informed consent for participation.
Exclusion criteria
Exclusion criteria: 1. Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger, or not requiring systemic treatment are permitted to enroll; 2. Known history of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or active Hepatitis B or C; 3. Subjects with severe pleural effusion, pericardial effusion, or ascites need repeated drainage. 4. Known history of platinum-based radiotherapy and chemotherapy; 5. Subjects with predominantly squamous cell histology NSCLC, or SCLC; 6. Subjects with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation. (except T790M mutation); 7. Radiation therapy to more than 30% of bone marrow or large-scale radiation fields within 4 weeks before the first dose of study drug; 8. Subjects with uncontrolled concurrent diseases, or there are mental illnesses / social conditions that limit compliance with research requirements, significantly increase the risk of AEs, or affect the ability of patients to provide written informed consent; 9. Known allergy or hypersensitivity to PD-1 antibody or its accessories; 10. Female subjects who are pregnant or lactation or who plan to be pregnant during the study period; 11. Researchers evaluated the situation is not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCR;ORR;AE; | — |
Countries
China
Contacts
The Affiliated Hospital of Xuzhou Medical University