Locally advanced non-small cell lung cancer
Conditions
Interventions
Test group:aderelimab
Sponsors
HenanCancerHospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood this research and voluntarily signed the informed consent form; 2. Age >=18 years old, gender not limited; 3.ECOG PS: 0 - 2 ; 4. Expected survival period >=12 weeks; 5. Patients diagnosed with non-small cell lung cancer (NSCLC) histologically or cytologically, and at stage IIA - IIIC who are unresectable or refuse surgery (as determined by the 9th Edition of the International Association for the Study of Lung Cancer (IASLC) Chest Tumor Staging Manual); 6. Patients who are assessed by researchers as unsuitable for chemotherapy (such as the elderly, those with poor PS scores or comorbidities, etc.) or those who refuse chemotherapy; 7. Radiotherapy with a total dose of 60Gy±10% was completed within 1 to 42 days before enrollment, and there was no disease progression. 8. The patient has at least one measurable lesion (in accordance with RECIST 1.1 criteria); 9. No EGFR-sensitive mutations or ALK gene rearrangements/patients; 10. Normal functions of major organs, that is, meeting the following criteria: (1) The criteria for blood routine examination should meet (no blood transfusion or blood products within 7 days, and no correction using G-CSF or other hematopoietic stimulating factors) : A. Hemoglobin (Hb) >= 90 g/L; B. Neutrophil count (ANC) >= 1.5 × 10^9/L; C. Platelet count (PLT) >=100 ×10^9/L; (2) Biochemical tests must meet the following standards: A. Total bilirubin (TBIL) 60ml/min (Cockcroft-Gault formula); D. The result of the routine urine test shows that the urine protein (UPRO) is less than 2+ or the 24-hour urine protein quantification is less than 1g; (3) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >=lower limit of normal value (50%); (4) Coagulation function: International Normalized ratio (INR) <=1.5×ULN and activated partial thromboplastin time <=1.5×ULN; 11. Women of childbearing age should agree to take effective contraceptive measures during the study period and for six months after the end of the study. The patient must have a negative serum or urine pregnancy test result within 7 days before enrollment in the study and must be a non-lactating patient. Male patients who should agree to the use of contraceptive measures during the study period and within six months after the end of the study period;
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to therapeutic drugs; 2. Histological or cytological confirmation of mixed NSCLC, neuroendocrine carcinoma and sarcomatoid carcinoma; 3. Patients whose imaging shows that the tumor has invaded important blood vessels or whose researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal massive hemorrhage during the subsequent study period; 4. Those with active autoimmune diseases or immune deficiencies, or with the following medical history, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc., are not eligible for inclusion. The following exceptions apply: Patients with a history of autoimmune hypothyroidism but who have received thyroid hormone replacement therapy can be included in the study. Patients with type 1 diabetes whose blood sugar was controlled after treatment with insulin administration regimens can participate in this study; 5. Those who have experienced hyperactive or venous thrombotic events within 6 months prior to the first administration, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis and pulmonary embolism; 6. Participated in another clinical study and used any of the investigational drugs within 28 days prior to the first use of the investigational drug; 7. Have received or plan to receive a live attenuated vaccine within 4 weeks prior to the first administration; 8. Within 5 years, the subject has had or concurrently suffered from other malignant tumors that require active treatment (except for those that have been fully treated, such as basal cell or squamous cell skin cancer with an expected 5-year survival period of over 90%, cervical carcinoma in situ, and breast cancer in situ). 9. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months prior to enrollment; Congestive heart failure with a New York Heart Association (NYHA) grade of >= 2; Ventricular arrhythmias requiring drug treatment (including QTc interval >= 450 ms in men and >= 470 ms in women); Left ventricular ejection fraction (LVEF) =CTCAE5.0 grade 2 infection), including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia, with unexplained fever >38.5? before the first administration (as determined by the researcher, fever caused by tumor reasons can be enrolled); 11.Subjects who required systemic treatment with corticosteroids (prednisone >10mg/ day or equivalent doses of the same hormone) or other immunosuppressants within 14 days before the first administration of the trial drug. The following situations are excluded: (1) Intranasal, inhaled, topical steroid treatment or local injection, steroid drugs (such as intra-articular injection); (2) Steroids as prophylactic administration for hypersensitivity reactions (such as pretreatment before CT scans); (3)Prophylactic systemic steroid administration as part of chemoradiotherapy for locally advanced NSCLC; 12. Those with a history of immune deficiency, including those who test positive for HIV or have other acquired or congenital immune deficiency diseases, o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year Progression Free Survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;Progression Free Survival,PFS;Duration of Response,DoR;Overall survival,OS;Objective Response Rate,ORR; | — |
Countries
China
Contacts
Public ContactHong Ge
HenanCancerHospital
Outcome results
None listed