Brain metastases of non-small cell lung cancer
Conditions
Interventions
intervention group:Sacituzumab govitecan with concurrent radiotherapy
Sponsors
The Second Affiliated Hospital of Hainan Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Prior to the implementation of any trial-related procedures, written informed consent must be obtained. 2.Age >= 18 years old, =12 weeks; 7.Intracranial metastatic lesions are present, and radiotherapy is planned. 8.Cranial MRI/CT evaluation revealed no evidence of meningeal dissemination, no severe cerebral oedema, and no intracerebral haemorrhage. 9.At least one measurable brain metastatic lesion according to RECIST 1.1 criteria; brain metastases previously treated with radiotherapy should not be selected as target lesions. 10.All acute toxicities resulting from prior antineoplastic therapy must have resolved to Grade 0-1 (per NCI CTCAE version 5.0) or to a level acceptable under the inclusion/exclusion criteria. 11.Sufficient organ and bone marrow function, with laboratory values meeting criteria within 7 days prior to randomisation. 12.For female subjects of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days prior to the first study drug administration (Day 1). 13. if there is a risk of pregnancy, all subjects (male or female) need to take contraceptive measures with an annual failure rate of less than 1% during the whole treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. Received treatment from another clinical trial or is currently participating in another clinical study within 4 weeks prior to enrolment; 2. Previous use of TROP2-targeted therapy and/or topoisomerase I inhibitor therapy; 3. Brain metastases not requiring radiotherapy intervention; 4. Severe brain metastases presenting with symptoms such as significant intracranial pressure elevation, uncontrolled seizures, severe vomiting and/or motor impairment; 5. Histological or cytological confirmation of concomitant small cell lung carcinoma, neuroendocrine carcinoma, or carcinosarcoma components; 6. History of other defined cancer types, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ following radical excision; 7. Known allergy to any drug in this regimen or its components; 8. Human immunodeficiency virus (HIV) positive status or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; 9. History of allogeneic organ transplantation or allogeneic haematopoietic stem cell transplantation; 10. Receipt of live attenuated vaccines within 4 weeks prior to first dosing or planned during the study period; 11. Requirement for strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to first dosing or during the study period (use of strong CYP3A4 inhibitors or inducers is not permitted in this study); All subjects must endeavour to avoid concomitant use of any known CYP3A4-inducing medications, herbal supplements and/or consumption of such foods; 12. Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, e.g., Type I diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, adrenal or pituitary insufficiency requiring only physiologically dosed glucocorticoid replacement therapy); 13. Use of immunosuppressive drugs within 4 weeks prior to first administration, excluding topical glucocorticoids administered via nasal spray, inhalation, or other local routes, or physiologically dosed systemic glucocorticoids (i.e., not exceeding 10mg/day prednisolone or equivalent doses of other glucocorticoids). Temporary use of glucocorticoids for symptomatic relief of respiratory distress in conditions such as asthma or chronic obstructive pulmonary disease is permitted; 14. Active or poorly controlled severe infection. History of severe infection within 4 weeks prior to first dose, including but not limited to hospitalisation due to infection, bacteraemia, or complications from severe pneumonia; 15. Concomitant conditions judged by the investigator to pose a serious threat to patient safety or compromise study completion, including but not limited to uncontrolled hypertension, severe diabetes mellitus, or active infection; 16. Documented history of severe dry eye syndrome, severe meibomian gland dysfunction and/or blepharitis, or corneal disease history that may impede delayed corneal healing; 17. Pregnant or lactating female subjects; female subjects of childbearing potential with a positive baseline pregnancy test who are unwilling to use effective contraception during treatment with the study drug and for 6 months after the last dose; 18. Any condition deemed by the investigator to interfere with the evaluation of the study drug, subject safety, or analysis of study results; or any other con
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of adverse events;Treatment related deaths;Objective intracranial response rate;Incidence of radiation-induced brain necrosis; | — |
Countries
China
Contacts
Public Contactseapalm
The Second Affiliated Hospital of Hainan Medical University
Outcome results
None listed