lung cancer
Conditions
Interventions
experimental group:cindilimab combined with chemotherapy
Sponsors
Tianjin Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Male or female >=18 years old and 6 months; 12. Sufficient organ function, subjects should meet the following laboratory indicators: (1) The absolute value of neutrophils (ANC) is >=1.5x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days. (2) Platelets >=100x10^9/L without blood transfusion in the past 14 days. (3) Hemoglobin > 9g/dL without blood transfusion or erythropoietin in the past 14 days; (4) Total bilirubin ULN but direct bilirubin =60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Myocardial enzyme spectrum is within the normal range (if the investigators comprehensively judge that simple laboratory abnormalities that are not clinically significant are also allowed to be included in the group); 13. For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 14. If there is a risk of conception, all subjects (regardless of male or female) are required to use th
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant diseases other than non-small cell lung cancer within 5 years before the first administration (excluding basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 2. Pathological diagnosis of neuroendocrine tumor 3. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 4. Previous therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or against another stimulating or synergistic inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137) drug; 5. Received systemic systemic treatment of Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration; 6. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 7. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (<=10 mg/day prednisone or equivalent) are allowed; 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Those who are known to be allergic to the active ingredients or excipients of the study drug sintilimab; 10. Have not recovered sufficiently from toxicity and/or complications from any intervention (ie, <= Grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiating treatment; 11. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive); 12. Untreated active hepatitis B (defined as HBsAg positive and the detection of HBV-DNA copy number greater than the upper limit of the normal value of the laboratory department of the research center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: (1) HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, subjects should receive anti-HBV therapy throughout the study chemotherapy drug treatment period to avoid viral reactivation (2) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation needs to be closely monitored 13. Active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the detection limit); 14. Received live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Injected inactivated virus vaccine against seasonal influenza within 30 days prior to the first dose is permitted; however, intranasal live attenuated influenza vaccine is not permitted. 15. Pregnant or lactating women; 16. Presence of any serious or uncontrollable systemic disease such as: (1) There are significant abnormalities in the rhythm, conduction or morphology of the resting ECG, and the symptoms are severe and difficult to control, such as complete le
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission ;Main pathological remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Security; | — |
Countries
China
Contacts
Public ContactZhang Zhenfa
Tianjin Cancer Hospital
Outcome results
None listed