non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18~79 years old man and woman; 2. The pathological/cytology diagnosis of non-small cell lung cancer patients with measurable focus; 3. When the patients were enrolled, the World Health Organization (WHO)/United States Eastern Oncology Cooperative Group (ECOG) scored 0 to 2; 4. EGFR and ALK wild-type non-small cell lung cancer patients by genetic testing; 5. The subjects voluntarily joined the study, and informed consent, good compliance, with the follow-up; 6. Researcher comfirm that patients can benefit from the drug.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to the test drug and/or its excipients; 2. Patients are using immunosuppressive agents, or systemic, or absorbable local hormonal therapies for immunosuppression purposes (dose >10 mg/day of prednisone or other therapeutic hormones) and still using in the first 2 weeks prior to enrollment; 3. The patient has any immunodeficiency disease or medical history, or has a history of organ transplantation; 4. Have clinical signs of brain metastasis or meningeal metastasis. Patients with treated brain metastases need to meet the following conditions before enrollment: >=4 weeks after treatment, no MRI proof of progress, >=28 days before the first study drug, the first dose of study drug 10 mg/day of prednisone or equivalent dose); 5. Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction; 6. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher; (2) unstable angina; (3) myocardial infarction within 24 weeks; (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia; 7. Patients with active pulmonary tuberculosis or with a history of active tuberculosis infection within <=48 weeks prior to screening (whether treated or not); 8. Pregnant or lactating women; 9. Patients who were judged by the investigator were not eligible for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;DOR;AE; | — |
Countries
China
Contacts
PLA Navy Anqing Hospital