Locally advanced resectable non-small cell lung cancer
Conditions
Interventions
experimental group:chemotherapy plus immunotherapy
Sponsors
Ethics Committee of the First Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients for this study must meet all of the following criteria: 1. Sign the written informed consent before implementing any test related process; 2. Male or female >= 18 years old and 6 months; 10. Sufficient organ function, subjects need to meet the following laboratory indicators: (1) In the past 14 days, when granulocyte colony stimulating factor was not used, the absolute value of neutrophil (ANC) was >= 1.5x10^9/l. (2) Platelets >= 100 x 10^9 / 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) The coagulation function was good, defined as INR or PT <= 1.5 times ULN; (8) Normal thyroid function, defined as TSH in the normal range. If the baseline TSH is out of the normal range, subjects with total T3 (or FT3) and FT4 in the normal range can also be enrolled; (9) The myocardial zymogram was in the normal range (for example, the simple laboratory abnormality without clinical significance judged by the researchers was also allowed to enter the group); 11. For female subjects of childbearing age, urine or serum pregnancy test shall be conducted within 3 days before the first study drug administration (day 1 of the first cycle) and the result shall be negative. If the result of urine pregnancy test cannot be confirmed as negative, blood pregnancy test is required. Women of non childbearing age are defined as postmenopausal women at least 1 year, who have undergone surgical sterilization or hysterectomy; 12. If there is a risk of pregnancy, all subjects (male or female) should adopt contraceptive measures with an annual failure rate of less than 1% during the whole treatment period and up to 120 days (or 180 days) after the last study drug administration.
Exclusion criteria
Exclusion criteria: Subjects who met the following criteria were excluded from the study: 1. Patients diagnosed as other malignant diseases other than NSCLC within 5 years before the first administration (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and / or radical resection of carcinoma in situ); 2. Patients who are currently participating in the intervention clinical research treatment, or have received other research drugs or used research instruments within 4 weeks before the first administration; 3. Patients who have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs for another stimulation or synergistic inhibition of T cell receptor (e.g., CTLA-4, OX-40, CD137); 4. Systemic systemic treatment for patients (including thymosin, interferon, interleukin, except for local use for control of pleural effusion) who have received Chinese patent medicine or immunomodulatory drugs with anti-tumor indications within 2 weeks before the first administration; 5. Active autoimmune diseases of patients requiring systemic treatment (such as the use of disease alleviation 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 insufficiency) is not considered as systemic therapy; 6. Study patients who are receiving systemic glucocorticoids (excluding local glucocorticoids by nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: it is allowed to use physiological dose of glucocorticoids (< 10 mg / day of prednisone or its equivalent and pre-treatment dose of glucocorticoids before chemotherapy); 7. Patients with known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Patients who are known to be allergic to active ingredients or excipients of PD-1; 9. Patients who have not fully recovered from toxicity and / or complications caused by any intervention before the start of treatment (i.e., <= level 1 or baseline, excluding fatigue or alopecia); 10. Patients with known HIV infection history (i.e. HIV 1 / 2 antibody positive); 11. Untreated active hepatitis B patients (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value of laboratory in the research center); Note: hepatitis B patients who meet the following criteria can also be included in the group: (1) Before the first administration, the HBV viral load was less than 1000 copies / ml (200 IU / ml). The subjects should receive anti HBV treatment to avoid virus reactivation during the whole chemotherapy treatment period of the study (2) For subjects with anti HBC +, HBsAg (-), anti HBS (-), and HBV viral load (-), prophylactic anti HBV treatment is not required, but virus reactivation needs to be closely monitored 12. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the detection limit); 13. Patients who received live vaccine within 30 days before the first administration (cycle 1, day 1); Note: it is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; however, it is not allowed to accept live attenuated influenza vaccine for intranasal administratio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PCR;DFS;Occurrence of surgical complications (intraoperative and perioperative complications;Serious drug-related adverse events; | — |
Countries
China
Contacts
Public ContactYang Bo
The First Medical Center of PLA General Hospital
Outcome results
None listed