Retrospective Study for Describing Real-World Effectiveness of Nivolumab + Chemotherapy in Neoadjuvant NSCLC in Argentina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Rate of pathological complete response (pCR) post-surgery
研究概览
简要总结
The purpose of this study is to evaluate the real-world effectiveness and safety of neoadjuvant nivolumab combined with chemotherapy in Argentinian patients with resectable non-small cell lung cancer (NSCLC)
详细描述
This is a non-interventional, retrospective, single-arm, multicenter study evaluating the real-world effectiveness of neoadjuvant nivolumab plus platinum-based chemotherapy in Argentinian patients with resectable non-small cell lung cancer (NSCLC). The primary objective is to estimate the rate of pathological complete response (pCR) following neoadjuvant therapy.
Adult patients (≥18 years) with newly diagnosed, early-stage, resectable NSCLC (stage IIA-IIIB, AJCC 8th ed) and no EGFR or ALK driver mutations who initiated neoadjuvant nivolumab (360 mg Q3W) plus platinum-based chemotherapy between July 1, 2022, and March 1, 2025, at participating Argentinian centers will be included. Data will be extracted retrospectively from medical records for up to 12 months following surgery or neoadjuvant therapy.
The primary endpoint is the pathological complete response (pCR), defined as absence of residual viable tumor in both lung and lymph nodes at surgery. Secondary endpoints include major pathological response (MPR), event-free survival (EFS) over 1 year, surgical outcomes, safety, and subsequent adjuvant therapy use. Descriptive and survival analyses will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Participants aged 18 years or older
- •Participants diagnosed with resectable non-small cell lung cancer (NSCLC) (stage IIA-IIIB TNM AJCC 8ed) according to the treating team's judgment
- •Participants who received nivolumab and chemotherapy as neoadjuvant therapy between 1st July 2022 and 1st March 2025
- •Participants must have given informed consent for their data to be used for research or academic studies, or a waiver of consent has been obtained
排除标准
- •Participants with confirmed positive EGFR gene mutation or ALK fusion gene, as the study focuses on the effectiveness of nivolumab in patients without these driver mutations
- •Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- •Participants who received any antineoplastic therapy within 3 months prior to initiating neoadjuvant nivolumab and chemotherapy, to avoid confounding effects from prior treatments
- •Participants who participated in a clinical trial for NSCLC, to ensure the study reflects real-world clinical practice
- •Participants with complications of treatment-related adverse events related to hematotoxicity of antineoplastic agents 3 months prior to the start of neoadjuvant therapy, to minimize risks and confounding factors
- •Participants who started neoadjuvant therapy outside the participating medical institution and were transferred to the institution for surgery, to ensure data consistency and reliability
研究组 & 干预措施
Cohort 1
Participants with resectable non-small cell lung cancer (NSCLC) receiving neoadjuvant treatment with nivolumab in combination with platinum-based chemotherapy
干预措施: Nivolumab + platinum-based chemotherapy (Drug)
结局指标
主要结局
Rate of pathological complete response (pCR) post-surgery
时间窗: Up to 1 year
Number of patients with complete pathological response (defined as absence of residual viable tumor in both lung and lymph nodes at surgery) divided by total number of patients.
次要结局
- Event-free survival (EFS)(Up to 1 year)
- Rate of major pathological response (MPR) post-surgery(Up to 1 year)
- Participant demographics(Baseline)
- Participant clinical characteristics(Baseline)
- Number of participants receiving surgery(Up to 1 year)
- Time from diagnosis to neoadjuvant treatment start before surgery(Up to 1 year)
- Number of nivolumab doses received before surgery(Up to 1 year)
- Type of chemotherapy given in combination to nivolumab adjuvant treatment before surgery(Up to 1 year)
- Relapse status(Up to 1 year)
- Surgery type(Up to 1 year)
- Extent of surgical resection(Up to 1 year)
- Surgical complications during or after surgery(Up to 1 year)
- Reasons for not having surgery(Up to 1 year)
- Treatment received after neoadjuvant treatment(Up to 1 year)
- Reason for having adjuvant treatment(Up to 1 year)
- Adverse events (AEs)(Up to 1 year)