Lung cancer
Conditions
Interventions
study group:half-dose chemotherapy combined with immunotherapy
control group:Standard-dose chemotherapy combined with immunotherapy
Sponsors
Lixia Ju
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age is not less than 18 years old and not more than 75 years old (on the day of signing the informed consent form); 2. The patient was diagnosed as non-squamous NSCLC by histology or cytology; 3. Initial treatment 4. Patients have measurable lesions (according to the RECIST 1.1 standard, the length of CT scan of tumor >= 10 mm, the short length of CT scan of lymph node >= 15 mm, the thickness of scanning layer is not more than 5 mm, and the measurable lesions have not received radiotherapy, freezing and other local treatment); 5. ECOG PS=2; 6. Expected life >= 3 months; 7. Organ function meets the following criteria: (1) Adequate bone marrow reserve (not treated with hematology or cytokine correction within 14 days prior to the first study): (2) Absolute neutrophil count >= 1.5 x 10^9/L, platelet count >=90 x 10^9/L, and hemoglobin >= 9 g/dL; (3) Liver: serum albumin >= 3.0 g / dL; total bilirubin = 50%; electrocardiogram is basically normal, average QTc <470 ms in 3 electrocardiogram during screening period; 8. For female subjects of childbearing age, they should be negative in urine or serum pregnancy test within 3 days before the first study drug administration. If the results of urine pregnancy test cannot be confirmed as negative, blood pregnancy test is required; 9. If there is a risk of pregnancy, male and female patients need to use efficient contraception (i.e. methods with a failure rate of less than 1% per year), which lasts for at least 180 days after stopping the trial treatment. Note: if abstinence is the normal lifestyle and preferred contraceptive method of the subject, abstinence can be accepted as a contraceptive method.
Exclusion criteria
Exclusion criteria: 1. Driver gene detection is positive for EGFR sensitive mutation or ALK fusion; 2. Any other study drug was used within 4 weeks prior to enrollment; 3. The patient has any active autoimmune disease, or has a history of autoimmune disease (including but not limited to: interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, thyroid hyperfunction, decreased thyroid function (can be included after hormone replacement therapy); vitiligo but without intervention after adulthood; childhood asthma has been completely relieved and without any intervention after adulthood, still need bronchodilator patients cannot be included; 4. Have congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the lower limit of any detection methods) or combined hepatitis B and hepatitis C co-infection; 5. Have uncontrolled heart clinical symptoms or diseases, such as (1) NYHA II and above heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 6. Severe infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks prior to the first dose, or unexplained fever > 38.5 degrees C during screening/first administration; 7. History of allogeneic organ transplantation or history of allogeneic hematopoietic stem cell transplantation; 8. Inoculate a live attenuated vaccine within 4 weeks prior to the first dose or during the study period; 9. Have had or have other systemic malignancies in the last 5 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ and ovarian cancer); 10. Those who are known to be allergic to any test drug; 11. Pregnant, lactating women, reproductively motivated subjects are reluctant to take effective contraceptive measures; 12. suffering from mental disorders that are difficult to control; 13. Other circumstances that the investigator believes are not suitable for inclusion. For example, patients with central nervous system metastases, severe laboratory abnormalities, with family or social factors, may affect the safety of the subject, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival (PFS);overall response rate (ORR); | — |
Countries
China
Contacts
Public ContactLixia Ju
Shanghai Pulmonary Hospital
Outcome results
None listed