Lung cancer
Conditions
Interventions
Experimental group:Lukotuzumab plus Tagrolimab
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, gender; 2. ECOG performance status score 0-1; 3. Histologically or cytologically confirmed small cell lung cancer (SCLC), staged as extensive-stage small cell lung cancer (ES-SCLC) according to the Veterans Affairs Lung Group (VALG) staging system; 4. Achieved complete response (CR), partial response (PR), or stable disease (SD) after induction therapy with 4 cycles of immune checkpoint inhibitors combined with platinum-based chemotherapy, and the time from the last dose of induction therapy to the start of maintenance therapy is = 1.5×10^9/L; platelet (PLT) >= 100×10^9/L; hemoglobin >= 9 g/dL; b. Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) = 60 ml/min (Cockcroft-Gault formula see attachment); d. Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) = 50%; 9. For female subjects of childbearing potential and male subjects with potential for fathering children, they must agree to take effective medical contraceptive measures from the time of signing the informed consent form until 6 months after the last dose. 10.The subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Non-small cell lung cancer (including mixed small cell and non-small cell lung cancer) 2. Previous treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors; 3. Previous use of topoisomerase I inhibitors and any ADC drugs targeting any other targets; 4. Untreated or symptomatic brain metastases; 5. Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin; 6. Known hypersensitivity to the drugs in this regimen or their components, history of immunodeficiency, or history of organ transplantation; 7. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, current ILD or non-infectious pneumonia, or suspicious ILD or non-infectious pneumonia that cannot be excluded by imaging at screening; 8. Clinically significant lung damage due to concurrent pulmonary diseases, including but not limited to any underlying pulmonary diseases (such as severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, etc. within 3 months before the first dose) or any autoimmune, connective tissue or inflammatory diseases that may involve the lungs (such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or previous pneumonectomy; 9. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal diseases that may impede delayed corneal healing; 10. 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 thyroid hormone replacement therapy, adrenal or pituitary insufficiency requiring only physiological doses of glucocorticoid replacement therapy); 11. Uncontrolled systemic diseases as judged by the investigator: a) Poorly controlled diabetes (fasting blood glucose >= 10 mmol/L on two consecutive occasions); b) Poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg); c) Presence of symptomatic or recurrent pleural effusion, pericardial effusion or ascites requiring repeated drainage (> 1 time/week); active infection requiring systemic treatment within 2 weeks before the first dose; 12. Known active pulmonary tuberculosis. Subjects suspected of having active pulmonary tuberculosis need to undergo clinical examination to rule it out; 13. Active hepatitis B [positive hepatitis B surface antigen (HBsAg), HBV-DNA testing is required; HBV-DNA >= 500 IU/mL or higher than the lower limit of detection, whichever is higher] or hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the lower limit of detection) or co-infection with HBV and HCV; 14. Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; 15. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 16. Subjects who have undergone major surgery within 4 weeks before dosing or are expected to undergo major surgery during the study period; 17. Subjects who have received non-specific immunomodulatory therapy (including but not limited to interferon, IL-2) or approved anti-tumor traditional Chinese medicine preparations within 2 weeks before dosing; 18. Subjects currently participating in interventional clinical r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival;Objective response rate;Duration of remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactChunxia Su
Shanghai Pulmonary Hospital
Outcome results
None listed