Non-small cell lung cancer, NSCLC
Conditions
Interventions
Experimental group(Sacituzumab Tirumotecan plus Tagitanlimab):Eligible patients will receive combination therapy with Sac-TMT and Tagitanlimab. Sac-TMT is administered intravenously at 4 mg/kg on Day
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and = 6 months after the last dose of such therapy; 6.At least one measurable lesion per RECIST v1.1. Lesions that have received prior radiotherapy should not be selected as target lesions. Subjects with only skin lesions or bone lesions are not eligible; 7.Life expectancy > 12 weeks; 8.Adequate organ and bone marrow function (without receipt of blood transfusion, recombinant human thrombopoietin, or colony-stimulating factors within 2 weeks prior to first dose), defined as follows: a. Hematology: Absolute neutrophil count (NEUT#) >= 1.5×10^9/L; Platelet count (PLT) >= 100×10^9/L; Hemoglobin >= 9 g/dL; b. Hepatic function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 60 mL/min; d. Coagulation: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) = 50% as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan; 9.Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use effective medical contraceptive measures from the time of signing informed consent until 6 months after the last dose; 10.Subjects voluntarily participate in this study, sign the informed consent form, are compliant, and willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Prior treatment targeting TROP-2, or treatment containing topoisomerase I inhibitors (including ADC drugs); 2.Prior use of immune checkpoint inhibitors including PD-(L)1 inhibitors, immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, or any other treatment targeting tumor immune mechanisms; 3.Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors; 4.Known leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, active or untreated central nervous system (CNS) metastasis. For subjects with previously treated brain metastases, participation is allowed if clinically stable for at least 4 weeks prior to first dose and no requirement for glucocorticoids or anticonvulsants for at least 14 days; for subjects with newly detected brain metastases at screening, if local treatment (e.g., radiotherapy) has been received, radiographic evidence of no progression of brain metastases for at least 4 weeks from initial radiographic diagnosis of brain metastases is required before enrollment; 5.Other malignancies within 2 years prior to first dose (except those cured by local treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.); 6.Presence of any of the following cardiovascular or cerebrovascular diseases or risk factors: a. Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, Grade 3 or 4 heart failure [per New York Heart Association (NYHA) classification], symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other severe cardiovascular or cerebrovascular diseases within 6 months prior to study drug administration; b. History of myocarditis, primary cardiomyopathy, specific cardiomyopathy, or other myocardial diseases; c. Any deep vein thrombosis (allowed if stable for >= 2 weeks on low molecular weight heparin or similar therapeutic agents), peripheral arterial thromboembolic event, pulmonary embolism, or other severe thromboembolic events within 3 months prior to study drug administration; d. Presence of aortic aneurysm, aortic dissection aneurysm, or other major vascular diseases that may be life-threatening or require surgery within 6 months prior to study drug administration; 7.Radiotherapy to thoracic lesions with total dose > 30 Gy within 6 months prior to first dose; non-thoracic radiotherapy with total dose > 30 Gy or extensive radiotherapy (including radionuclide therapy such as Strontium-89) within 4 weeks prior to first dose; palliative radiotherapy for symptom control is permitted but must be completed at least 2 weeks prior to first dose; 8.Uncontrolled systemic diseases per investigator judgment: a) Poorly controlled diabetes (fasting blood glucose >= 10 mmol/L on two consecutive measurements); b) Poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg); c) Clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage (> 1 time/week); 9.Severe infection within 4 weeks prior to first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective treatment within 2 weeks prior to first dose; 10.History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Disease Control Rate(DCR);Overall Survival(OS);Safety and tolerability: including incidence and severity of adverse events, drug-relatedness, dose modification/discontinuation, vital signs and laboratory parameter changes, etc.; | — |
Countries
China
Contacts
Public ContactBaohui Han
Shanghai Chest Hospital
Outcome results
None listed