Advanced Non-Small Cell Lung Cancer
Conditions
Interventions
Sacituzumab tirumotecan Combined with Bevacizumab:Sacituzumab tirumotecan Combined with Bevacizumab
Sponsors
HenanCancerHospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years at the time of signing the informed consent form, with no restriction on gender; 2.Histologically or cytologically confirmed advanced or metastatic NSCLC (Stage IIIB-IV); 3.Progression after previous treatment with EGFR-TKI or other corresponding targeted therapies, and having received at least one line of systemic therapy (such as chemotherapy or immunotherapy); 4.Having at least one measurable target lesion as assessed by the investigator in accordance with RECIST v1.1; 5.Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1; 6.Expected survival >= 12 weeks; 7.Availability of tumor tissue or peripheral blood samples for detecting TROP2 expression levels; 8.Sufficient organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin or colony-stimulating factor therapy received within 2 weeks before the first dose), defined as follows: a) Routine blood test: Neutrophil count (NEUT#) >= 1.5×10^9/L; Platelet (PLT) >= 100×10^9/L;.Hemoglobin >= 90 g/L; Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 30 g/L;Total bilirubin (TBIL) = 50 ml/min (calculated using the standard Cockcroft-Gault formula); Coagulation function: International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) <= 1.5×ULN; 9.For female subjects of childbearing potential and male subjects whose partners are of childbearing potential, they must agree to use effective medical contraceptive measures from the time of signing the informed consent form until 6 months after the last dose;Subjects voluntarily participate in this study, sign the informed consent form, and are able to comply with the visits and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1,Participation in other drug clinical trials within 4 weeks before enrollment; 2.Presence of active brain metastasis; 3.Previous receipt of bevacizumab or other anti-angiogenic drugs;patients with tumor invasion of large blood vessels confirmed by imaging, or those judged to have a high risk of fatal massive bleeding due to tumor invasion of important blood vessels during the subsequent study period;patients with bleeding tendencies such as acute gastrointestinal bleeding, persistent bleeding disorders, or coagulation dysfunction; 4.Previous treatment with TROP2-targeted therapy and/or topoisomerase I inhibitor therapy; 5.History of other malignant tumors within the past 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin; 6.Known history of allergy to the drugs in this protocol or their components; 7.Positive human immunodeficiency virus (HIV) test result or history of acquired immunodeficiency syndrome (AIDS);known active syphilis infection; 8.History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 9.Vaccination with live vaccines within 30 days before the first study drug administration; 10.History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment;current presence of ILD or non-infectious pneumonia;or suspicious ILD or non-infectious pneumonia that cannot be excluded by imaging examination at screening;clinically severe lung damage caused by concurrent pulmonary diseases, including but not limited to any underlying lung diseases (such as pulmonary embolism within 3 months before drug administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.);or previous total pneumonectomy; 11.History of active autoimmune diseases requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as type 1 diabetes, hypothyroidism requiring only levothyroxine replacement therapy, and adrenal or pituitary insufficiency requiring only physiological doses of glucocorticoid replacement therapy); 12.Active infection requiring systemic treatment within 2 weeks before the first drug administration; 13.Concomitant diseases that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study, including but not limited to poorly controlled hypertension, severe diabetes, active infection, etc. 14.Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal diseases that impede delayed corneal wound healing; 15.Pregnant or lactating female patients;female patients of childbearing potential with a positive baseline pregnancy test;female patients of childbearing potential who are unwilling to take effective contraceptive measures during the study drug treatment period and within 6 months after the last dose; 16.Any other conditions deemed by the investigator to make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Safety;Overall Survival (OS);Duration of Response (DOR);Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactWu Hongbo
Henan Cancer Hospital
Outcome results
None listed