Lung Cancer
Conditions
Interventions
Test group:Adebelizumab was combined with extracranial radiotherapy, and maintenance adebelizumab was continued after completion of radiotherapy.
Control subjects:Adebelizumab maintenance therapy.
Sponsors
Nanjing Tianyinshan Hospital/Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be enrolled in this trial: 1. Age =18 years old, male or female; 2. Extensive-stage small-cell Lung cancer confirmed histologically or cytologically according to the Veterans Administration Lung Study Group (VALG) stage; 3. First-line responders after 4 cycles of adbelimumab combined with etoposide and carboplatin; (4) Extracranial lesions = 3 5. Life expectancy of more than 3 months; 6. ECOG performance status score 0-1; 7. Women of childbearing age must have a serum pregnancy study with a negative result within 7 days before the first dose. Female participants of childbearing age and male participants whose partner was a woman of childbearing age had to agree to use contraception within 24 weeks after signing the informed consent form and receiving the last dose of study drug. 8. Good organ function; 9. The subjects voluntarily participated in this study, signed the informed consent form, with good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: Subjects with any of the following cannot be enrolled in this study: 1. Patients with brain and liver metastases after first-line treatment with 4 cycles of adebelimumab, etoposide and carboplatin; 2. clinically symptomatic third interstitial fluid requiring repeated drainage, such as pericardial, pleural, and peritoneal effusions uncontrolled by aspiration or other treatment; 3. Uncontrollable or symptomatic hypernatremia; 4. other concurrent malignancies = 5 years prior to the first dose, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localised prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery (hormonal therapy for non-metastatic prostate or breast cancer is permitted); 5. active, known or suspected autoimmune disease, including, but not limited to, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus rheumatoid arthritis, inflammatory bowel disease. Type I diabetes mellitus (glycaemic control by insulin therapy), residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy, or lack of exogenous stimuli in the absence of expected recurrence are allowed to be enrolled; patients with eczema, psoriasis, chronic lichen simplex moss, or vitiligo dermatological manifestations only (psoriatic arthritis needs to be excluded) may be enrolled if the rash Covering less than 10% of the body surface area, adequately controlled at baseline and requiring only low-potency topical steroid therapy, with no acute exacerbation of the underlying disease in the past 12 months (no need for psoralens plus ultraviolet radiation [PUVA], methotrexate, retinoids, biologics, oral calmodulin phosphatase inhibitors, high potency, or oral steroids) may be admitted to the study; 6. previous treatment with any T-cell co-stimulation or immune checkpoint therapy, including, but not limited to, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other drugs that target T cells; 7. HBsAg positivity with HBV DNA copy number greater than the upper limit of normal value (1000 copies/ml or 500 IU/ml) in the laboratory of the research centre, or HCV positivity (HCV RNA or HCV Ab test suggestive of acute or chronic infections); known history of HIV positivity or known Acquired Immune Deficiency Syndrome (AIDS); known history of HIV positivity or known Acquired Immune Deficiency Syndrome (AIDS). Deficiency Syndrome (AIDS); 8. History of idiopathic pulmonary fibrosis, organic pneumonia (e.g., occlusive bronchiolitis), drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or clinically symptomatic active pneumonia; or other moderate-to-severe lung disease that severely affects lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area may be eligible for this study); 9. subjects with active tuberculosis (TB) or a history of active TB infection within = 48 weeks prior to screening, with or without treatment; 10. presence of severe infection at the time of randomisation, including but not limited to complications of infection requiring hospitalisation, bacteraemia, severe pneumonia, etc; 11. major surgery within 28 days prior to randomisation or planning to undergo major surgery during the study; 12. use of a live attenuated vaccine within 28 days prior to randomisation or anticipate the need for such a live attenuated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;PFS rates at 6 months and 1 year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of sustained remission;Overall survival at 1 and 2 years;Safety; | — |
Countries
China
Contacts
Public ContactYong Song/Xia He
Nanjing Tianyinshan Hospital/Jiangsu Cancer Hospital
Outcome results
None listed