Lung cancer has become the leading cause of cancer death for both males and females worldwide. Lung cancer, as the most common malignant tumor in China, has as many as 780000 new cases and 650000 deaths. In recent decades, due to a large number of smokers and air pollution, the incidence rate of lung cancer in China has become higher and higher. Lung cancer is divided into small cell lung cancer (
Conditions
Interventions
Test group:serplulimab injection
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Both male and female, aged = 18 and = 75 years old; 2. The expected lifespan exceeds 6 months; 3. NSCLC with locally advanced unresectable (stage III) disease according to the International Association for Research on Lung Cancer and the Joint Committee on Cancer Classification, 8th edition of the TNM staging classification for lung cancer; According to RECIST 1.1, a mass >= 5cm, tumor with atelectasis or metastatic lymph node short diameter >= 2cm; 5. The Eastern Cancer Collaborative Group (ECOG) scored 0-1 on physical fitness status; 6. Have not received any systematic anti-tumor treatment for advanced diseases in the past; 7. Cytological gene testing confirmed that the driver 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 × 10^9/L, platelet count >= 100 × 10^9/L exclusion criteria, hemoglobin >= 90 g/L; 9. Adequate liver function: Aspartate transaminase (AST) = 50ml/min (Cockcroft Gault 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 scope of anticoagulant drug formulation; 12. Patients should use efficient contraception and continue for at least 180 days after discontinuing the trial treatment. And confirm that female patients of childbearing age have a negative urine pregnancy test or serum pregnancy test within 3 days before receiving the first study drug administration. The subjects understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. If mixed type 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 20 Gy (V20) exceeding 40% of lung capacity; 3. Have received chest radiotherapy, including radiotherapy for esophageal or breast cancer; 4. Received any immunotherapy or study drug within 4 weeks prior to the first dose of the study drug; Patients who have experienced any arterial thrombosis, embolism, ischemic or hemorrhagic disease within the past 6 weeks or months prior to the first use of the investigational drug using monoclonal antibodies and have not improved or become unstable after corresponding treatment, such as unstable myocardial infarction, unstable angina, cerebrovascular accidents, etc. after treatment; 5. Within 28 days prior to the use of the first dose of the investigational drug, immunosuppressive drugs have been or have been used, except for systemic corticosteroids inhaled or at physiological doses, which do not exceed 10 mg/day of prednisone or equivalent corticosteroids. Allow the use of systemic steroid therapy in locally advanced NSCLC radiotherapy and chemotherapy to control the toxicity caused by radiotherapy; 6. There have been 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. Have a history of mild meningeal cancer; 9. Uncontrolled concurrent diseases, including but not limited to persistent or active infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmias, active peptic ulcers or gastritis, active bleeding, including any known patient with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), or mental illness/social conditions that limit compliance with research requirements or impair the patient's ability to provide written informed consent; 10. Known history of pulmonary tuberculosis; 11. Administer attenuated live vaccines within 30 days prior to entering the study or within 30 days after receiving the study drug; 12. There is a history of another primary malignant tumor within 5 years prior to the start of drug research, except for fully treated skin basal cell carcinoma, squamous cell carcinoma, in situ cervical cancer, and the studied disease; 13. Have experienced hemoptysis within the past 3 months, with bleeding defined as bright red blood greater than or equal to 2.5ml; 14. Individuals who have been confirmed to be allergic to or contraindicated to Slulimumab or its excipients; 15. Surgical treatment is required within the past 60 days; 16. Have a history of gastrointestinal perforation in the past 6 months; 17. Have undergone allogeneic tissue/solid organ transplantation; 18. There are known mental or drug abuse disorders that can affect the requirements for cooperating with the study;2.Any situation that researchers believe will interfere with the evaluation of the investigational drug or the interpretation of patient safety or research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate (ORR);the changes in radiation dosimetry (lung V20 and mean dose) before and after study treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS);Overall survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactWei Huang
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed