| Eligibility |
Inclusion Criteria:
1. Age :18 Years to 75 Years;
2. ECOG physical score status of 0 or 1 points;
3. Expected survival time = 6 months;
4. According to the eighth edition of the AJCC/UICC TNM staging system, patients were
pathological diagnosed with Stage III NSCLC and had one of the following conditions:
1) A complete resection (R0) would not be possible, based on evaluation within a
multidisciplinary team, including an experienced thoracic surgeon; 2) Multiple
ipsilateral mediastinal lymph nodes metastasized into large masses or multistation
metastases (IIIA: T1-2N2 or IIIB: T3-4N2); 3) Contralateral hilar or mediastinal lymph
nodes, or ipsilateral or contralateral scalene or supraclavicular lymph nodes
metastasis (IIIB: T1-2N3; IIIC: T3-4N3); 4) The lesion invaded the heart, aorta, or
esophagus (IIIA: T4N0-1).
5. EGFR mutation or ALK mutation was negative;
6. Patients with at least one evaluable or measurable lesions as per RECIST version 1.1;
7. Patients were newly diagnosed with non-small cell lung cancer, without radiotherapy,
chemotherapy, surgery or molecule-targeted treatment.
8. Patients must have enough cardiopulmonary function for the expected pulmonary
resections for lung cancer.
9. The main organ function meets the following criteria:1) Blood routine:a. ANC =
1.5×109/L; b. PLT = 100×109/L; c. HB = 90 g/L; 2) Blood biochemistry:TBIL =
1.5×ULN;ALT?AST= 2.5×ULN;sCr=1.5×ULN; 3) Blood coagulation: INR=1.5×ULN and
APTT=1.5×ULN,endogenous creatinine clearance rate=45ml/min(Cockcroft-Gault formula);
10. Pregnancy test (serum or urine) has to be performed for woman of childbearing age
within 7 days before enrolment and the test result must be negative. They shall take
appropriate methods for contraception during the study until the 3 months post the
last administration of study drug. For men, (previous surgical sterilization
accepted), shall agree to take appropriate methods of contraception during the study
until the 3 months post the last administration of study drug;
11. Patient has to voluntarily join the study and sign the Informed Consent Form for the
study.
Exclusion Criteria:
1. Patients with autoimmune disease, or a history of autoimmune disease within 2 years
prior to the first use of the study drug including but not limited to the following:
autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary
inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism
which can be included after hormone replacement therapy; Subjects with childhood
asthma have been completely alleviated and without any intervention or vitiligo in
adulthood can be included;
2. Subjects with congenital or acquired immunodeficiency such as HIV infection, active
hepatitis B (HBV DNA = 2000 IU/mL), hepatitis C (hepatitis C antibody is positive);
3. Subjects with a condition requiring other immunosuppressive medications before 7 days
of study drug administration firstly, not including inhaled corticosteroids or
physiological doses of systemic treatment with either corticosteroids (> 10 mg daily
prednisone equivalents);
4. Has received a live vaccine within 4 weeks of planned start of study therapy;
5. Other malignancies have been diagnosed within 5 years prior to the first use of the
study drug (excluding skin basal cell carcinoma that has been cured, skin squamous
cell carcinoma, and / or carcinoma in situ that has undergone radical resection);
6. Patients with a current or history of pulmonary fibrosis, interstitial pneumonia,
pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment of
lung function;
7. Patients with serious or uncontrollable systemic diseases, such as:
Patients with hypertension that is difficult to control (systolic blood pressure =140
mmHg and diastolic blood pressure =90 mmHg); Patients with myocardial ischemia and
myocardial infarction above class II (including QT interval prolongation, for man =
450 ms, for woman = 470 ms);
8. Severe infection within 4 weeks before the first administration (such as intravenous
drip of antibiotics, antifungal drugs or antiviral drugs), or fever of unknown origin
(> 38.5 ?) within 4 weeks before the first administration;
9. Allogeneic organ transplantation (except corneal transplantation) or allogeneic
hematopoietic stem cell transplantation;
10. Pregnant or nursing women;
11. Patients with a history of hypersensitivity to any of the study drugs, similar drugs,
or excipients;
12. Participated in other clinical trials within 4 weeks;
13. Patients has received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2
drugs or drugs that target another stimulator or synergistically inhibit T cell
receptors (e.g., CTLA-4, OX-40, CD137);
14. The investigator believes that there are any conditions that may damage the subject or
result in the subject being unable to meet or perform the research request.
|
