Patients with Bone Metastases from Advanced Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Experimental group:Denosumab 120 mg, subcutaneous injection, once every 6 weeks.
Control group:Denosumab 120 mg, subcutaneous injection, once every 4 weeks.
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Obtain the signed informed consent form from the patient. 2.Age greater than or equal to 18 years. 3.ECOG performance status score of 0-2, with an expected survival of >= 3 months. 4.Subjects must have adequate organ reserve functions (bone marrow, liver and kidney function, and coagulation function). 5.Able to comply with the study protocol and follow-up procedures, and capable of receiving injectable drug treatments. 6.The target population includes individuals with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer, evaluated by the researcher as inoperable or unsuitable for surgical resection, and unsuitable for other curative treatments [AJCC (American Joint Committee on Cancer) 8th edition TNM staging IIIB, IIIC, or IV]. 7.Evidence of bone metastasis on imaging exams (such as CT, MRI, bone scan, etc.). 8.Hematology: absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >=8 g/dL. 9.Not participating in other clinical trials that may affect the results of this study.
Exclusion criteria
Exclusion criteria: 1.History of allergic reactions to Denosumab or similar medications. 2.Concurrent severe bone disease or metabolic disorders (such as severe osteoporosis). 3.Presence of severe heart, liver, kidney diseases, or other serious comorbidities. 4.Received other types of bone repair medications (e.g., bisphosphonate therapy) within the past six months. 5.Patients who have recently (within 6 months) participated in other advanced treatment clinical trials and experienced significant adverse reactions. 6.Patients who have received any treatment before the initiation of the study drug that may affect the assessment of the trial's efficacy. 7.Pregnant women or nursing mothers, and women planning to become pregnant during the study period. 8.Individuals with severe mental disorders or behavioral problems who cannot comply with the study procedures. 9.Suffering from or having a history of other malignancies within the past 5 years, except effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast. 10.Active infections, such as active tuberculosis or hepatitis B/C virus infection. 11.Severe acute or chronic infections. 12.Patients deemed unsuitable for participation in this study by the investigator, such as those who are likely unable to comply with the protocol, constraints, and requirements; or other situations at the investigator's discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Skeletal-Related Events (SREs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival period; | — |
Countries
China
Contacts
Public ContactWenmei Su
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed