non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age =18 years old and =75 years old; 2.According to the 9th edition of Lung Cancer TNM staging of the International Association for Lung Cancer Research and the Joint Commission for the United States on Cancer Classification, subjects with local late stage (III B/III C), metastatic or recurrent (stage IV) non-squamous NSCLC who cannot be surgically removed by histology or cytology and cannot receive radical synchronous radiochemotherapy; 3.Patients with brain metastasis, liver metastasis or pleural metastasis or pleural effusion; 4.Have at least one measurable foci (according to the RECIST v1.1 standard); locate the measurable foci located in the field of previous radiotherapy irradiation or after local treatment. If progress is confirmed, it can be selected as a target foci; 5.In the past, it is allowed to receive first-line systemic anti-tumor treatment for local advanced or metastatic NSCLC; if the patient is first-line treatment when entering the group, the subjects are allowed to have received auxiliary treatment in the past, but the recurrence of the disease should be at least 6 months apart from the last administration of auxiliary treatment or the last radical radiotherapy; 6.The Eastern United States Oncology Collaborative Group (ECOG) has a physical fitness score (PS) of 0 to 1; 7.Expected survival time =3 months; 8.Have sufficient organ function; 9.Voluntarily participate in the research and sign the informed consent form; 10.The second stage of treatment: progress according to the solid tumor response evaluation standard (RECIST) 1.1 standard.
Exclusion criteria
Exclusion criteria: 1. There is a history of experimental drug allergy; 2. EGFR/ALK/ROS1 Positive; 3. Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy and other anti-tumor drugs within 3 weeks before the first administration; 4. Suffering from other malignant tumors in the past 5 years, except for the malignant tumors that have been cured; 5. The adverse reactions of previous antitumor treatment have not recovered to NCI-CTCAE v5.0 grade evaluation =1 (except for toxicity that researchers judge that there is no safety risk, such as hair loss, level 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement treatment, etc.); 6. Have a history of immunodeficiency, or suffer from other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation; 7. Combined history of myocardial infarction, history of heart failure, active infection; 8. Have a history of serious cardiovascular disease, including but not limited to: a) severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II~III degree atrioventricular conduction block; correction of QTcF intervals >450 milliseconds for men and >470 milliseconds for women; b) acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of level 3 or above within 6 months before the first administration; c) New York Heart Association of the United States (NYHA) heart function classification >= level II or left ventricular blood output fraction (LVEF) =100 mmHg); 9. Pregnant, pre-pregnancy and lactating women; 10. The researchers evaluated that the patient's compliance was poor, and it was impossible to guarantee the treatment and follow-up of patients according to the research plan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress Free Survival 1;The second stage Disease Control Rate;The second stage Objective response rate;Progress Free Survival2; | — |
Countries
China
Contacts
Henan Cancer Hospital