non-small cell lung cancer (NSCLC)
Conditions
Interventions
Experimental group:Sacituzumab tirumotecan combined?with?anlotinib
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age at the time of signing the informed consent form is >= 18 years and = 12 weeks; 11.Have adequate organ and bone marrow function (without receiving blood transfusion, recombinant human thrombopoietin or colony-stimulating factor treatment within two weeks before first administration), defined as follows: a)Complete blood count: Neutrophil count (NEUT#) >= 1.5×10^9/L; Platelets (PLT)>= 100×10^9/L; Hemoglobin>= 90 g/L; b)Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 30g/L; Total bilirubin (TBIL) = 50 ml/min (calculated using the standard Cockcroft-Gault formula); d)Coagulation fu
Exclusion criteria
Exclusion criteria: 1.Histologically or cytologically confirmed combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components; 2.Central squamous cell carcinoma with a high risk of massive hemoptysis; 3.Previously received any of the following treatments (including in the adjuvant or neoadjuvant setting): a)TROP2-targeted therapy; b)Any drug therapy targeting topoisomerase-?, including antibody-drug conjugate (ADC) therapy; c)Anlotinib or other anti-angiogenic drugs; 4.Subjects known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, active central nervous system (CNS) metastasis. For subjects with brain metastases who have previously received local treatment, if they are clinically stable for at least 4 weeks prior to the first dose and without need for corticosteroids or anticonvulsants at least14 days prior to the first dose, they may participate in the study; For subjects with brain metastases who have not previously received local treatment, if they are asymptomatic (e.g., no neurological dysfunction, seizures, or other typical CNS metastasis symptoms and signs), not requiring corticosteroids or anticonvulsants, and the largest diameter of brain metastasis lesion= 2weeks after treatment with low molecular weight heparin or similar drugs, enrollment is allowed), peripheral arterial thromboembolism, pulmonary embolism, or other severe thromboembolic events; d)Presence of aortic aneurysm, aortic dissection aneurysm, or other major vascular diseases that may be life-threatening or require surgery within 6 months before administration; e)Average corrected ventricular depolarization to repolarization time (QTcF) interval> 480 ms; f)Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) 160 mmHg and/or diastolic blood pressure> 100 mmHg); c)Presence of clinically symptomatic or requiring repeated drainage of pleural effusion, pericardial effusion, or ascites (> 1time/week); 8.Presence of steroid-requiring (non-infectious) interstitial lung disease (ILD) or a history of non-infectious pneumonitis, currently having ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis that cannot be ruled out by imaging at screening; 9.Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or presen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR);Disease Control Rate (DCR);Overall Survival (OS);Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactQian Chu
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed