non-small cell lung cancer
Conditions
Interventions
Sponsors
Fujian Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old = 3 months; 6. No previous surgery, Newly diagnosed patients with other treatments such as radiotherapy, chemotherapy, targeted therapy or immunotherapy; 7. Females of childbearing age must have a negative pregnancy test (serum or urine) result within 14 days before enrollment. Male subjects and females of childbearing age must be contraceptive within 24 weeks after starting the first dose of the study drug to the last study drug; 8. The laboratory test values of the patients before taking the drug must meet the following standards: (1) Blood routine: WBC >= 3.0 × 10^9 /L; ANC >= 1.5 × 10^9/L; PLT >= 100 × 10^9/L; HGB >= 9.0 g/dL; (2) Liver function: AST = 50 mL/min 4) Coagulation function: INR <= 1.5, APTT <= 1.5 ×ULN; 9. The subjects voluntarily joined the study, signed the informed consent, good compliance, and cooperated with follow-up .
Exclusion criteria
Exclusion criteria: 1. Received any T cell co-stimulation or immune checkpoint therapy in the past, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other drugs targeting T cells; 2. Past or current history of other cancers other than NSCLC, except for non-melanoma skin cancer, in situ cervical cancer or other cancers that have received curative treatment and have no signs of recurrence for at least 5 years; 3. Interstitial lung Disease, drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy, or clinically symptomatic active pneumonitis or severe pulmonary dysfunction; 4. Uncontrolled hypertension with standard therapy (blood pressure not stable below 2 grade) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization; 8. There are clinically uncontrollable third-space effusion (such as pleural effusion/pericardial effusion, no need for drainage of effusion or patients with no significant increase in effusion after stopping drainage for 3 days can be enrolled); 9. Imaging (CT or MRI) shows that the tumor invades large blood vessels 10. Those with a history of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and history of allogeneic bone marrow transplantation; 11. Active hepatitis B (defined as positive hepatitis B virus surface antigen [HBsAg] test results during the screening period and HBV-DNA test values higher than the upper limit in the laboratory department of the research center) or hepatitis C ( Defined as patients with positive hepatitis C virus surface antibody [HCsAb] test results and positive HCV-RNA during the screening period; 12. Those who have allergic reactions to the test drugs of this application; 13. According to the judgment of the investigator, the subjects have other factors that may forced the discontinuation of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR);Surgical R0 resection rate;Objective Response Rate (ORR);Surgical complications (bleeding, anastomotic fistula, incision infection), operation time, hospital stay, etc.;Incidence, nature, and severity of adverse events, including serious adverse reactions (according to NCI-CTCAE V4.0 criteria); | — |
Countries
China
Contacts
Public ContactPan Xiaojie
Fujian Provincial Hospital
Outcome results
None listed