NSCLC
Conditions
Interventions
Experimental group:ctDNA Dynamic Monitoring for the Therapeutic Efficacy of Sacituzumab Tirumotecan
Sponsors
Shaanxi Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old at the time of signing the informed consent form, with no restriction on gender; 2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), which is locally advanced (Stage ?B/?C) or metastatic (Stage ?) non-squamous NSCLC ineligible for radical surgery and/or radical radiotherapy (regardless of whether concurrent chemotherapy is received), and with EGFR-sensitive mutations (19del or L858R); 3. Patients who have previously received EGFR-TKI treatment for locally advanced or metastatic NSCLC and experienced treatment failure (radiological disease progression), including those who progressed after third-generation EGFR-TKI treatment or progressed after first/second-generation EGFR-TKI treatment with negative T790M. Patients who have previously received immunotherapy, anti-angiogenic therapy, or chemotherapy are also eligible for enrollment; 4. Have 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 or 1; 6. Expected survival period >= 12 weeks; 7. Sufficient organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment received within 2 weeks before the first dose), defined as follows: a) Routine blood test: Neutrophil count (NEUT#) >= 1.5×10?/L; Platelet (PLT) >= 100×10?/L; Hemoglobin >= 90 g/L; b) 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); d) Coagulation function: International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT), and Prothrombin Time (PT) <= 1.5×ULN; 8. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to use effective medical contraceptive measures from the time of signing the informed consent form until 6 months after the last dose; 9. Subjects voluntarily participate in this study, sign the informed consent form, and are able to comply with the visits and relevant procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Having participated in other drug clinical trials within 4 weeks prior to enrollment. 2. A history of receiving treatments targeting TROP2 and/or treatments with topoisomerase I inhibitors . 3. Having suffered from other malignant tumors within the past 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or cutaneous squamous cell carcinoma. 4. A known medical history of allergy to the drugs in this protocol and their components. 5. Positive result for Human Immunodeficiency Virus (HIV) test, a medical history of Acquired Immunodeficiency Syndrome (AIDS); or known active syphilis infection. 6. Having received a live vaccine within 30 days before the first administration of the study drug. 7. A history of (non-infectious) Interstitial Lung Disease (ILD) or non-infectious pneumonia requiring steroid treatment; current presence of ILD or non-infectious pneumonia; or suspected ILD or non-infectious pneumonia that cannot be ruled out by imaging examinations during 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 prior to drug administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.), any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or a prior history of total pneumonectomy. 8. Suffering from an active autoimmune disease that required systemic treatment within the past 2 years. (Hormone replacement therapy is not considered systemic treatment, such as type 1 diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, and adrenal or pituitary insufficiency requiring only physiological doses of glucocorticoid replacement therapy.) 9. An active infection requiring systemic treatment within 2 weeks before the first drug administration. 10. According to the investigator's judgment, having concurrent diseases that seriously endanger the patient's safety or affect the patient's completion of the study, including but not limited to uncontrollable hypertension with drugs, severe diabetes mellitus, active infections, etc. 11. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal diseases that impede or delay corneal healing. 12. Female patients who are pregnant or lactating; female patients of childbearing potential with a positive baseline pregnancy test; and female patients of childbearing potential who are unwilling to adopt effective contraceptive measures during the treatment with the study drug and within 6 months after the last administration. 13. Any other circumstances in which the investigator deems the patient unfit to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Circulating tumor DNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Objective response rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactZheng Zhao
Shaanxi Provincial Cancer Hospital
Outcome results
None listed