NSCLC
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old, male or female; 2. Patients with untreated stage IV non-small cell lung cancer confirmed by histopathology or cytology; 3. According to the RECIST1.1 standard, the subject must have a measurable target lesion through CT or MRI examination, and the tumor imaging evaluation should be carried out within 28 days before the first medication; 4. No known target driver gene mutation; 5. ECOGPS score 0-1 points; 6. Expected survival period >= 6 months.
Exclusion criteria
Exclusion criteria: 1. Those who have been confirmed to be allergic to the test drug and/or its excipients; 2. Subjects who have received or are receiving additional chemotherapy, radiation therapy, targeted or immunotherapy; 3. Suffering from any active autoimmune disease or history of autoimmune disease; 4. Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBVDNA >= 500 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the analysis the lower limit of detection of the method) or co-infection with hepatitis B and C; or a history of organ transplantation; 5. Have clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) Heart failure above NYHA level 2; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; 6. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Countries
China
Contacts
The First Affiliated Hospital of Anhui Medical University