Non-Small Cell Lung Cancer
Conditions
Interventions
Single Arm:Sintilimab 200 mg, administered on the first day by intravenous infusion, Q3W. Continuous administration to the presence of confirmed PD, toxicity intolerance, subject voluntarily withdrawa
Sponsors
The First People's Hospital of Foshan
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Sign written informed consent before any trial-related processes are implemented; 2) Aged 18 to 75 years; 3) Life expectancy exceeds 3 months; 4) The enrolled patients were confirmed to have at least one measurable lesion according to RECIST 1.1 criteria; 5) According to the 8th edition of lung cancer TNM staging, histologically or cytologically confirmed locally advanced (IIIB/IIIC), metastatic or recurrent (IV) NSCLC; 6) DDR pathway gene mutations; 7) The Eastern Cancer Cooperative Group (ECOG) has a fitness status score of 0 or 1; 8) Failure to accept first-line or above treatment; 9) Other details are shown in the research protocol.
Exclusion criteria
Exclusion criteria: 1) Histopathological diagnosis of patients with small cell lung cancer; 2) Patients with known EGFR-sensitive mutations, ALK rearrangements, or ROS1 rearrangements; 3) Any active autoimmune disease or a history of autoimmune disease; 4) Having other malignant tumors at the same time or before; 5) Previously received other PD-1 antibody therapy or other checkpoint monoclonal antibodies therapy, including CTLA-4, PD-L1 immunotherapy; 6) The investigator judged that the subject had other factors that might cause him to be forced to terminate the study midway; 7) Other details are shown in the research protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactFeng Weineng
Oncology Department of the First People's Hospital of Foshan
Outcome results
None listed