KCT0004363已完成未知
EVALUATION OF BLOOD TUMOR MUTATION BURDEN FOR IMPROVED EFFICACY OF ATEZOLIZUMAB IN 2L+ NON-SMALL CELL LUNG CANCER [BUDDY]
Chonnam National University Hospital Hwasun Hospital0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
Results: A total of 100 patients were enrolled. The cfDNA oncentration was measured in 86 samples, and the bTMB was measured in 64 ctDNA samples at C0, and 48 paired ctDNA samples at C4/EOT. The overall ORR was 10%, and there was no difference in ORR according to bTMB (cutoff: 11.5 muts/Mb) at C0 (bTMBhi 8.1% vs. bTMBlo 11.1%). However, the C4 or EOT/C0 bTMB ratio was significantly lower in patients with a durable clinical benefit (DCB). The cfDNA concentration at C0, the C4/C0 cfDNA concentration ratio, the highest variant allele frequency (hVAF), and the standard deviation of VAF (VAFSD) were significantly lower in patients with DCB. In the multivariate analysis, a high cfDNA concentration at C0 (cutoff: 8.6 ng/mL) and C4/C0 bTMB ratio greater than 1 were significant risk factors for PFS. Conclusion: In previously treated NSCLC patients, the baseline levels and dynamic changes of blood-based biomarkers, including bTMB, cfDNA concentration, and VAFSD, could predict the treatment efficacy of atezolizumab.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Signed Informed Consent Form
- •Ability to comply with protocol
- •Aged = 18 years
- •Histologically or cytologically confirmed NSCLC that is locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC at the study enrollment.
- •Disease progression during or following treatment with a prior platinum-containing regimen for NSCLC
- •Patients may have received one or more additional cytotoxic chemotherapy regimen.
- •Patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving atezolizumab.
- •Measurable disease, as defined by RECIST v1.1
- •Measurable disease is defined by the presence of at least one measurable lesion by RECIST v1.1
- •ECOG performance status of 0 – 2
- •Life expectancy = 12 weeks
- •Adequate hematologic and end organ function:
- •ANC = 1.0 x 109/L
- •WBC counts > 2.5 x 109/L
- •Hemoglobin = 8.0 g/dL
- •Total bilirubin ? 2.5 X UNL
- •Patients with known Gilbert’s disease who have serum bilirubin level ? 3 x ULN may be enrolled.
- •AST, ALT, and alkaline phosphatase = 2.5 × ULN, with the following exceptions:
- •Patients with documented liver metastases: AST and ALT = 5 × ULN
- •Patients with documented liver or bone metastases: alkaline phosphatase = 5 ×
排除标准
- •Active or untreated CNS metastases
- •Patients with a history of treated CNS metastases that are asymptomatic are eligible
- •Malignancies other than NSCLC within 5 years prior to study enrollment, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated surgically with curative intent)
- •Pregnant and lactating women
- •Women of childbearing potential should use effective contraception during treatment with atezolzumab and for at least 5 months following the last dose.
- •Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to study enrollment
- •Patients with autoimmune disorder or a history of chronic or recurrent autoimmune disorder
- •Patients with a history of autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.
- •Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study.
- •Uncontrolled idiopathic pulmonary fibrosis or drug-induced pneumonitis
- •Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to study enrollment
- •Treatment with inhaled corticosteroid or megesterol acetate is permitted.
- •Patient with a known hypersensitivity to atezolizumab or any of the excipients
研究者
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