Lung Cancer
Conditions
Interventions
single arm:PD-1 monoantibody + chemotherapy
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subject's written informed consent has been obtained prior to any process, sampling, or analysis related to the study; 2. Male or female is not limited, and the age is not less than 18 years old (on the day of signing the informed consent form); 3. The patient was diagnosed as NSCLC by histology or cytology; 4. The tumor is locally advanced or metastatic NSCLC and is not suitable for radical surgery or radiotherapy; 5. Patients failed on first-line systemic therapy and has not used any PD-1/PD-L1 inhibitors; the treatment used in the neoadjuvant treatment phase is not included in the treatment plan; postoperative adjuvant chemotherapy, from the end of treatment to recurrence > 6 months, does not count the number of previous regimens; 6. At least one baseline tumor lesion in the patient can meet the following requirements: no previous radiotherapy, no biopsy during the screening period, and accurate or repeated measurement with CT or MRI. The longest diameter in the baseline period is >= 10mm (if Lymph nodes require a short axis >= 15 mm). If there is only one measurable lesion, the baseline assessment is allowed to be completed at least 14 days after the screening biopsy; 7. ECOG PS score 0~1 points, expected survival period >=12 weeks; 8. 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 >=1.5×10^9/L, platelet count >=90×10^9/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; 9. Female subjects and partners who are women of childbearing age should be sterilized or must agree to use high-efficiency methods during the study period and within 1 month after the end of the study period; non-surgical sterilization Female subjects of childbearing age must have a negative serum HCG test within 3 days prior to study enrollment and must be non-lactating subjects.
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 degree 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 |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;12-month progression-free survival rate;Adverse event; | — |
Countries
China
Contacts
Public ContactShengxiang Ren
Shanghai Pulmonary Hospital
Outcome results
None listed