| Eligibility |
Inclusion Criteria:
Sign written informed consent
- The participant signs and dates a written informed consent form. The informed consent
form must be signed before any protocol-related procedures (not part of the
participant's routine medical care) are performed.
- The participant must be willing and able to comply with scheduled visits, treatment
regimens, and laboratory tests.
Participant types and target disease characteristics
-Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 Histologically
confirmed non-small cell lung cancer, clinical stage IIB (tumors =4cm), II, IIIA (lymph
nodes limited to N1) according to the UICC lung cancer staging system (8th edition).
There are measurable lesions according to RECIST criteria.
- Participants must have tumor tissue samples available for PD-L1 (22c3 kit) IHC
testing, with PD-L1 expression =50%
- Within 3 months, lung function should reach at least FEV1>1.0L, FEV1%>40%.
According to the definition of laboratory test results described below, there is sufficient
hematology and vital organ function, and the test results need to be completed within 14
days before the first study treatment:
1. Blood routine (within 14 days before the first study treatment without receiving
hematopoietic stimulating factors or blood transfusions): absolute neutrophil count
(ANC) = 1.5 × 109/L, absolute lymphocyte count (LC) = 0.5 × 109/L; platelet count
(PLT) = 100 × 109/L, hemoglobin (Hb) = 90g/L
2. Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3
xULN; total bilirubin (TBIL) =1.5 x ULN (for patients with confirmed Gilbert syndrome,
total bilirubin =3.0 mg/dL); albumin (ALB) =3 g/dL;
3. Renal function: creatinine clearance rate (CrCl) =45mL/minute (using the
Cockcroft-Gault formula);
4. Coagulation function: international normalized ratio (INR) =1.5, activated partial
thromboplastin time (APTT) =1.5 x ULN;
5. Cardiac color Doppler ultrasound examination: left ventricular ejection fraction
(LVEF) =50% Age and fertility status Age =18 and =75. Women of childbearing age
(WOCBP) must have a negative serum or urine pregnancy test within 24 hours before
starting the study treatment (the minimum sensitivity of HCG is 25 IU/L or equivalent
units).
- Female must be in a non-lactating state
Exclusion Criteria:
Histologically or cytologically confirmed mixed SCLC and NSCLC, large cell neuroendocrine
carcinoma, and sarcomatoid carcinoma; NSCLC non-squamous histological type with EGFR
mutation-positive or ALK-positive subjects. Non-squamous subjects must undergo EGFR gene
testing and ALK gene and/or immunohistochemical testing, with TPS score <50%; Malignant
pleural effusion. If the subject has pleural effusion that can be aspirated during the
screening period, at least one pleural puncture is required to confirm the presence of
malignant cells; Previous systemic treatment for non-small cell lung cancer (including
clinical study medication) has been received. If the subject has previously received
traditional Chinese medicine for anti-tumor treatment, the end of the treatment must be
separated from the first study medication by a time interval of no less than 2 weeks;
Previous thoracic radiotherapy has been received; Participation in other clinical studies
within 4 weeks before the first dose or 5 half-lives of the study drug, whichever is
shorter; Systemic immune stimulation therapy (including but not limited to interferon or
interleukin-2, including immune stimulation agents in clinical trials) within 4 weeks
before the first dose; Systemic immunosuppressive therapy (including but not limited to
glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, antineoplastic
cytokines) within 2 weeks before the first dose or is expected to be required during the
study treatment period. Subjects who have received short-term, low-dose (=10mg/day
prednisone or equivalent dose) systemic immunosuppressive drugs or short-term high-dose
systemic immunosuppressive drugs (such as for treatment of contrast agent allergy with
glucocorticoids for 48 hours) may be included in the study after obtaining approval from
the medical monitor. Subjects who use glucocorticoids (=10mg/day prednisone or equivalent
dose) for treatment of chronic obstructive pulmonary disease, mineralocorticoids for
treatment of orthostatic hypotension, and physiological replacement doses of
glucocorticoids for treatment of adrenal insufficiency may be included; There are
autoimmune diseases. The following conditions are allowed: type I diabetes (blood sugar can
be controlled by insulin therapy); hypothyroidism caused by autoimmune thyroiditis that
only needs hormone replacement therapy; only vitiligo dermatosis (psoriatic arthritis needs
to be excluded); History of other malignancies (except non-small cell lung cancer) within
the screening period, excluding cervical carcinoma in situ, basal cell or squamous cell
skin cancer, localized prostatic cancer, ductal carcinoma in situ, hormone replacement
therapy for non-metastatic prostate cancer or breast cancer; Known or suspected
interstitial pneumonia or other serious lung diseases that may interfere with lung toxicity
testing or treatment, including significant respiratory function impairment; Severe
cardiovascular diseases such as NYHA classification II or higher, myocardial infarction or
cerebrovascular accident (stroke, hemorrhagic stroke) within 3 months before the first
dose, unstable arrhythmia or unstable angina within 1 month before the first dose;
Significant bleeding symptoms or bleeding tendency within 1 month before the first dose,
such as gastrointestinal bleeding, gastric ulcer bleeding, or suffering from
thromboangiitis obliterans; Deep venous thrombosis and pulmonary embolism within 3 months
before the first dose; HIV positive; Active hepatitis B (HBsAg positive and HBV-DNA test
result higher than the upper limit of normal in the local laboratory during screening) or
hepatitis C (HCV-Ab positive and HCV-RNA positive during screening); Active tuberculosis
infection within 1 year before the first dose; Serious infection within 4 weeks before the
first dose, including hospitalization and/or antibiotics treatment for =2 weeks for
infections such as sepsis, severe pneumonia, etc.; antibiotics treatment for active
infections within 2 weeks before the study treatment; Vaccination with live attenuated
vaccines within 28 days before the first dose; Major surgery within 28 days before the
first dose; Previous or planned allogeneic bone marrow transplantation or solid organ
transplantation; History of severe allergic reaction to other monoclonal antibody / fusion
protein drugs; Allergic to any component of the investigational product; Pregnant,
breastfeeding, or planning to become pregnant during the study period; Subjects with a
history of substance abuse, alcoholism, or drug addiction; The researchers believe that any
other medical (such as pulmonary, metabolic, endocrine, or neurological diseases,
congenital diseases, etc.), psychiatric, or social conditions that may interfere with the
rights, safety, health, or ability of the subjects to sign informed consent, collaborate
and participate in the study, or interfere with the evaluation of study drugs,
interpretation of patient safety, or study results.
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