non-small cell lung cancer
Conditions
Interventions
Adebrelimab combined with Concurrent radiotherapy and chemotherapy sequential Adebrelimab treatment group:Adebrelimab+pemetrexed/Albumin paclitaxel+ carboplatin/cisplatin,The dose of chest radiation t
Concurrent radiotherapy and chemotherapy sequential Adebrelimab treatment group:pemetrexed/Albumin paclitaxel+ carboplatin/cisplatin,The dose of chest radiation therapy is 60-66Gy/30-33f.
Consolidatio
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Both male and female, aged 18 - 75 years old; 2. The expected lifespan exceeds 6 months; 3. According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification of the United States, 8th edition of the TNM staging classification for lung cancer, NSCLC with locally advanced unresectable (stage III) diseases; 4.According to RECIST 1.1, there are measurable lesions; 5. The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-1 points; 6. Has not received any systematic anti-tumor treatment for advanced diseases in the past; 7. Cytological gene testing confirmed that the driving gene was negative (EGFR mutation, ALK fusion mutation, c-MET amplification, ROS-1 mutation were all negative); 8. Adequate hematological function: Absolute neutrophil count=1.5×109/L, platelet count= 100×109/L exclusion standard, hemoglobin=90 g/L; 9.Adequate liver function: Aspartate transaminase (AST)=2.5 x ULN in patients without liver metastasis; Alanine aminotransferase (ALT)=2.5 x ULN, and ALT and AST=5 x ULN in liver metastasis patients; Total bilirubin (TBIL) in serum=1.5 x ULN (excluding Gilbert syndrome with TBIL=3.0 mg/dL); 10. Adequate renal function: defined as creatinine clearance rate=50ml/min (Cockcroft Fault formula); 11. Adequate coagulation function: International standardized ratio (INR) or prothrombin time (PT) = 1.5 times the upper normal limit; If the patient is receiving anticoagulant treatment, INR/PT should be within the range of anticoagulant drugs proposed; 12. Patients should use efficient contraception and continue until at least 180 days after discontinuing the trial treatment. And confirm that female patients of childbearing age received negative urine pregnancy test or serum pregnancy test within 3 days before the first study drug administration. 13. The patients understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.If mixed lung cancer contains small cell carcinoma, neuroendocrine carcinoma, or sarcoma components, it cannot be included in the group; 2. The radiation therapy plan may include participants with a total lung capacity of 20Gy (V20) exceeding 31% of lung capacity; 3. Have received chest radiotherapy, including radiotherapy for esophageal or breast cancer; 4. Have received any immunotherapy or study medication within 4 weeks prior to the first dose of the study medication; Patients who have experienced any arterial thrombosis, embolism, ischemic or hemorrhagic disease within 6 weeks or nearly 6 months prior to the first use of the study drug and have not improved or become unstable after corresponding treatment, such as unstable myocardial infarction, unstable angina, cerebrovascular accidents, etc; 5.Within 28 days prior to the use of the first dose of the investigational drug, immunosuppressive drugs were currently or previously used, except for systemic corticosteroids in nasal and inhaled corticosteroids or physiological doses, which do not exceed 10 mg/day of prednisone or equivalent corticosteroids. Allowing the use of systemic steroid therapy in locally advanced NSCLC radiotherapy and chemotherapy to control the toxicity caused by radiotherapy; 6. Active or previously recorded autoimmune diseases within the past 2 years. Note: Patients with vitiligo, Graves' disease, or psoriasis who do not require systemic treatment (within the past 2 years) are not excluded. 7. Active or previously recorded inflammatory bowel diseases (such as Crohn's disease, ulcerative colitis); 8.Uncontrolled concurrent diseases, including but not limited to persistent or active infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, arrhythmia, active peptic ulcer or gastritis, active bleeding, including any known patient with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), Or mental illness/social conditions may limit compliance with research requirements or impair the patient's ability to provide written informed consent; 9. Known history of active pulmonary tuberculosis; 10. Inoculate live attenuated vaccines within 30 days before entering the study or within 30 days after receiving the study medication; 11. There is a history of another primary malignant tumor within 5 years prior to the start of the drug study, except for fully treated skin basal cell carcinoma, squamous cell carcinoma, or cervical cancer in situ and the studied disease; 12.Individuals who have been confirmed to be allergic or contraindicated to adelbilimab or its excipients; 13. Surgical treatment is required within the past 60 days; 14. Have a history of gastrointestinal perforation in the past 6 months; 15. Have undergone allogeneic tissue/solid organ transplantation; 16. There are known mental or drug abuse disorders that may affect the requirements for cooperating with the study; 17. Any situation that the researcher believes will interfere with the evaluation of the investigational drug or the interpretation of patient safety or the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate evaluated by researchers;duration of response;Disease control rate evaluated by researchers;over-all survival;Progression free survival rates at 1 and 2 years;Survival rates at 1 and 2 years;The incidence and severity of adverse events (AE) and severe adverse events (SAE) evaluated based on CTCAE 5.0, as well as abnormal laboratory examination indicators;; | — |
Countries
china
Contacts
Public ContactJianbin Li
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed