lung cancer
Conditions
Interventions
Non-squamous cell cancer group:Sintilimab+pemetrexed combined platinum protocol
Squamous cell cancer group:Sintilimab+paclitaxel combined with platinum regimen
Sponsors
Cancer Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Sign written informed consent before implementing any test-related procedures; 2.Male or female, aged 18 to 75 years; 3.Non-small cell lung cancer diagnosed by cytology or histology; 4.According to the evaluation standard of solid tumor curative effect (RECIST version 1.1), there is at least one imaging measurable lesion; 5.Patients with stage Ia-IIIa non-small cell lung cancer who have not been treated and can be surgically removed by researchers must have a tumor diameter of > 2 cm; 6.EGFR and ALK driving genes are negative; 7.If the EGFR/ALK status is unknown or not detected at the time of randomization, patients can still be selected for study (at this time, patients can be tested for EGFR/ALK with surgical specimens after surgery), and the EGFR/ALK mutation patients in this study will be controlled at about 20% of the total randomized patients (i.e., about 8 cases); 8.Patients who agree to undergo radical surgery; 9.Thoracic surgeons judge patients without surgical taboos; 10.ECOG score 0-1; 11.The expected survival time is more than 6 months; 12.For sufficient organ function, subjects should meet the following laboratory indicators: (1)Absolute value of neutrophils (ANC) >=1.5x10^9/L in the absence of colony stimulating factor for the last 14 days. (2)Under the condition of no blood transfusion in recent 14 days, platelet >= 100x 10^9/l. (3)Hemoglobin > 9g/dl without blood transfusion or erythropoietin in recent 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 is defined as thyroid-stimulating hormone (TSH) in normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled. (9)The myocardial enzyme spectrum is within the normal range (if the investigator's comprehensive judgment is not clinically significant simple laboratory abnormalities are also allowed to be included); 13.Female subjects of childbearing age should receive urine or serum pregnancy test within 3 days before the first study drug administration (the first day of the first cycle), and the result is negative. If urine pregnancy test results cannot be confirmed as negative, blood pregnancy test is required. Non-childbearing age women are defined as at least one year after menopause, or have undergone surgical sterilization or hysterectomy; 14.If there is pregnancy risk, all subjects (male or female) should adopt contraceptive measures with annual failure rate less than 1% during the whole treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1.Diagnosed as malignant diseases other than non-small cell lung cancer within 5 years before the first administration (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or carcinoma in situ after radical resection); 2.Currently participating in intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 3.Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (for example, CTLA-4, OX-40 and CD137); 4.Received systematic systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunoregulatory effects (including thymosin, interferon and interleukin, except for controlling local use of pleural effusion) within 2 weeks before the first administration; 5.Active autoimmune diseases requiring systemic treatment (e.g., using disease-relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Substitution therapy (such as thyroxine, insulin or physiological glucocorticoid for adrenal or pituitary dysfunction, etc.) is not regarded as systemic treatment; 6.The study is receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoid) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: It is allowed to use physiological dose of glucocorticoid (<=10 mg/ day prednisone or equivalent drug); 7.Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8.Patients are known to be allergic to the active ingredients or auxiliary materials of the drug sintilimab in this study; 9.Before starting treatment, it has not fully recovered from the toxicity and/or complications caused by any intervention measures (i.e., <= grade 1 or reaching the baseline, excluding fatigue or alopecia); 10.Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 11.Untreated active hepatitis B (defined as HBsAg positive and detection of HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center); Note: hepatitis B subjects who meet the following criteria can also be enrolled: (1)Before the first administration, the HBV viral load was less than 1000 copies /ml(200 IU/ml), and the subjects should receive anti-HBV treatment during the whole study chemotherapy treatment to avoid virus reactivation; (2)For subjects with anti-HBc(+), HBsAg(-), anti-HBs(-) and HBV viral load (-), there is no need to receive preventive anti-HBV treatment, but it is necessary to closely monitor virus reactivation. 12.Active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the detection limit); 13.The live vaccine was inoculated within 30 days before the first administration (the first cycle, the first day); Note: it is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; However, live attenuated influenza vaccines administered intranasally are not allowed. 14.Pregnant or lactating women; 15.There are any serious or uncontrollable systemic diseases, such as: (1)The resting electrocardiogram has significant abnormalities in rhythm, co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pathological remission rate;Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difficulty of operation;Operation delay rate;Security; | — |
Countries
China
Contacts
Public ContactYou Jian
Cancer Hospital of Tianjin Medical University
Outcome results
None listed