NCT06667154招募中2 期
Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-Dose Nivolumab Combined With Chemotherapy
Aline Fusco Fares, MD1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年10月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Major Pathologic Response
研究概览
简要总结
The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide a signed Informed Consent Form (ICF), indicating agreement to comply with the requirements and restrictions in the ICF and protocol.
- •Male or female, aged 18 years or older.
- •Diagnosed with non-small cell lung cancer (NSCLC) with clinical staging IB, II, or IIIA.
- •Receiving treatment at Hospital de Base.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment, with no decline from two weeks prior to the baseline period or the day of the first dose.
- •Tumor sample meets the following requirements:
- •Negative for EGFR gene expression.
- •Negative for ALK and ROS1 protein expression.
- •PD-L1 protein expression documented and assessable.
- •Tumor is considered resectable upon initial assessment by three thoracic oncology surgeons (IR, CM, and HN) following a multidisciplinary review.
- •Adequate organ and bone marrow function as defined below:
- •Hemoglobin: ≥ 9.0 g/dL*
- •Absolute neutrophil count: ≥ 1.5 × 10^9 /L*
- •Platelet count: ≥ 100 × 10^9 /L*
- •*Note: Granulocyte colony-stimulating factor (G-CSF), platelet transfusions, and blood transfusions are not permitted to meet these values.
- •Serum bilirubin: ≤ 1.5 × upper limit of normal (ULN), except for participants with confirmed Gilbert syndrome, who may be included upon physician consultation.
- •ALT and AST: ≤ 2.5 × ULN.
- •Creatinine clearance: ≥ 50 mL/min (calculated using the Cockcroft and Gault formula).
- •Life expectancy greater than six months prior to randomization.
排除标准
- •Refusal to sign the Informed Consent Form (ICF).
- •NSCLC clinical stages IA, IIIB N3, IIIC, IVA, and IVB.
- •Tumors with T4 invasion of the aorta, esophagus, and/or heart; or presence of bulky N2 disease.
- •Tumor deemed unresectable.
- •Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drugs.
- •History of another primary malignancy, with exceptions for:
- •Malignancies treated with curative intent and no active disease for ≥ 2 years before the first dose of investigational product (IP) and with a low risk of recurrence.
- •Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease.
- •Adequately treated carcinoma in situ with no evidence of disease.
- •Incomplete basic medical information in the electronic medical record.
- •Positive for EGFR gene expression.
- •Positive for ALK protein expression.
- •No available data on PD-L1 protein expression.
- •Positive for ROS1 protein expression.
- •Pregnant or breastfeeding at the time of enrollment.
研究组 & 干预措施
Low-dose nivolumab combined with platinum-based doublet chemotherapy
Experimental
干预措施: Low-dose nivolumab combined with platinum-based doublet chemotherapy (Drug)
结局指标
主要结局
Major Pathologic Response
时间窗: 2-3 months
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.
Pathologic Complete Response
时间窗: 2-3 months
Pathological complete response (pCR) is defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review of the surgical specimen.
次要结局
- Adverse Events(Up to 3 months after the end of treatment)
- Event-Free-Survival(Up to 60 months)
- R0 resection(Up to 3 months)
研究者
Aline Fusco Fares, MD
MD
Fundação Faculdade Regional de Medicina de São José do Rio Preto
研究点 (1)
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