Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab Injection+Chemotherapy
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1Capable of understanding and voluntarily signing the informed consent form for this study. 2Age >= 18 years, regardless of gender. 3Histologically confirmed Stage IIIA or IIIB non-small cell lung cancer (NSCLC); 4ECOG performance status of 0 or 1; 5Eligible to receive platinum-based doublet chemotherapy. 6At least one measurable lesion at baseline (per RECIST 1.1 criteria). 7Adequate organ function within 7 days before the first treatment (no use of blood products or hematopoietic growth factors within 14 days prior to enrollment): ; Hemoglobin (Hgb) >= 90 g/L ; White blood cell count (WBC) >= 3.5 × 10^9/L ; Absolute neutrophil count (ANC) >= 1.5 × 10^9/L ; Platelets >= 80 × 10^9/L ; AST/ALT = 50 mL/min) ; Left ventricular ejection fraction (LVEF) >= 50% ; QTcF interval (Fridericia correction) <470 ms; 8. Fertile patients must agree to use reliable contraception (along with their partner) during the trial and for at least 180 days after the last dose.
Exclusion criteria
Exclusion criteria: 1Inability to comply with the study protocol or procedures. 2Presence of EGFR sensitizing mutations and/or ALK gene fusion mutations. 3Prior treatment for the current lung cancer (including chemotherapy or radiotherapy). 4Locally advanced unresectable disease or metastatic disease. 5Hypersensitivity or allergic predisposition to the study drug or its excipients. 6History of esophageal or gastric variceal bleeding due to portal hypertension within 6 months before the first dose, or severe varices identified by endoscopy within 3 months before the first dose. 7Current interstitial lung disease (ILD) or pneumonitis, or prior ILD/pneumonitis requiring steroid treatment, or other conditions (e.g., pulmonary fibrosis, organizing pneumonia) that may interfere with the assessment or management of immune-related pulmonary toxicity. 8Any of the following concurrent conditions: (1) Uncontrolled hypertension, coronary artery disease, arrhythmia, or heart failure. (2) Uncontrolled severe concurrent infection. (3) Proteinuria >= 2+ (1.0> g/24 h). (4) Bleeding tendency or history within 2 months before enrollment, regardless of severity. (5) Arterial/venous thromboembolic events (e.g., cerebrovascular accident, transient ischemic attack) within 12 months before treatment. (6) Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months before treatment. (7) Unhealed fractures or chronic wounds. (8) Coagulopathy, bleeding tendency, or ongoing anticoagulation therapy. 9Active autoimmune disease or history of autoimmune disease within 4 weeks before enrollment. 10Prior allogeneic bone marrow or solid organ transplantation. 11Any other condition deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete pathological remission rate;Major pathological response rate, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event Free Survival, EFS; | — |
Countries
China
Contacts
Public ContactJun Chen
Tianjin Medical University General Hospital
Outcome results
None listed