Small cell lung cancer
Conditions
Interventions
Experimental Group:Lucatumumab combined with immune checkpoint inhibitors
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old, gender not limited; 2.ECOG performance status score: 0-1; 3. Histologically or cytologically confirmed small cell lung cancer (SCLC), classified as extensive-stage small cell lung cancer (ES-SCLC) according to the American Veterans Association for Lung Cancer (VALG) staging; 4. After four cycles of induction therapy with immune checkpoint inhibitors combined with platinum-based chemotherapy in the first line, the patient was in complete response (CR), partial response (PR), or stable disease (SD) levels, and the time from the end of induction therapy (the last administration) to the start of maintenance therapy was = 1.5×10^9/L; Platelet count (PLT) >= 100×10^9/L; Hemoglobin >=9g/dL; b. Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) = 60 ml/min (the Cockcroft-Gault formula is attached); d. Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) =50%; 9. For female subjects with fertility and male subjects whose partners have reproductive potential, they must agree to take effective medical contraceptive measures from the date of signing the informed consent form until 6 months after the last administration (for details, see Annex 3); 10. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1.Non-small cell lung cancer (including mixed lung cancer of small cell carcinoma and non-small cell carcinoma) 2. Previously used treatments targeting TROP2 and/or topoisomerase I inhibitors; 3. Previously used topoisomerase I inhibitors and any ADC drugs targeting the target; 4. Untreated or symptomatic brain metastases; 5. Having suffered from other malignant tumors within the past five years, excluding cured cervical carcinoma in situ, cutaneous basal carcinoma or cutaneous squamous cell carcinoma; 6. It is known that there is a history of allergy to the drugs and their components in this protocol, a history of immune deficiency, or a history of organ transplantation; 7. There is a history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment. Currently, there is ILD or non-infectious pneumonia, or there is suspected ILD or non-infectious pneumonia that cannot be ruled out by imaging examinations during screening. 8. Severe clinical lung damage caused by concurrent lung diseases, including but not limited to any underlying lung diseases (such as severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, etc. within 3 months prior to the first administration) or any autoimmune, connective tissue or inflammatory diseases that may involve the lungs (i.e. Rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.) Or previous pneumonectomy; 9. A recorded history of severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal disease that hinders delayed corneal healing; 10. Suffering from active autoimmune diseases that have required systemic treatment within the past two years (hormone replacement therapy is not considered systemic treatment, such as type 1 diabetes, hypothyroidism that only requires thyroid hormone replacement therapy, and adrenal or pituitary insufficiency that only requires physiological dose glucocorticoid replacement therapy); 11. According to the researchers' judgment, uncontrollable systemic diseases: a) Poorly controlled diabetes (fasting blood glucose >=10mmol/L for two consecutive times); b) Poorly controlled hypertension (systolic blood pressure >160mmHg and/or diastolic blood pressure >100mmHg); c) There is pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage (more than once a week); Active infections requiring systemic treatment within 2 weeks before the first administration; 12. Known active pulmonary tuberculosis. Subjects suspected of having active pulmonary tuberculosis need to undergo clinical examinations to rule them out. 13. Active hepatitis B [positive for hepatitis B surface antigen (HBsAg), HBV-DNA testing is required; HBV-DNA>=500IU/mL or higher than the lower limit of the detection value, whichever is higher] or hepatitis C (positive for hepatitis C antibody and HCV-RNA higher than the lower limit of the detection value) or simultaneous infection with BHV and HCV; 14. Positive test for human immunodeficiency virus (HIV) 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. Those who have undergone major surgery within 4 weeks before administration or are expected to need major surgery during the study period; 17. Having received non-specific immunomodulatory therapy (including
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate;Overall survival;Disease control rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactZhou Jin
Sichuan Cancer Hospital
Outcome results
None listed