A Retrospective Study of Deoxyribonucleic Acid and Ribonucleic Acid Next-Generation Sequencing in Non-Small Cell Lung Cancer Patients With Non-Pathologic Complete Response Following Neoadjuvant Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Proportion of driver-alteration-positive patients detected by combined DNA+RNA testing
研究概览
简要总结
This multicenter, retrospective cohort study plans to enroll patients with lung adenocarcinoma who received neoadjuvant immunotherapy prior to surgery and did not achieve pathological complete response (non-pCR) upon postoperative pathological evaluation. Using Deoxyribonucleic Acid(DNA) and Ribonucleic Acid(RNA) next-generation sequencing (NGS), the investigators aim to detect driver genetic alterations to investigate the real-world frequency of driver gene positivity in postoperative samples from patients with lung adenocarcinoma-whose EGFR and ALK status had been previously excluded via pathological complete response(pCR) or DNA-based next-generation sequencing-yet still did not attain pathological complete response(pCR) after neoadjuvant immunotherapy. Additionally, the study will characterize the driver-positive patient subgroup and compare the efficacy of postoperative adjuvant immunotherapy between driver-positive and driver-negative populations.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older, regardless of sex.
- •Pathologically confirmed, resectable non-small cell lung cancer (NSCLC); having received neoadjuvant therapy containing immune checkpoint inhibitors prior to surgery; without achieving pathological complete response (non-pCR) upon postoperative pathological assessment.
- •Molecular characteristics: Pre-treatment biopsy specimens tested negative for EGFR mutations and ALK fusions by DNA-based NGS or PCR methods.
- •Sample requirements: Availability of 5-10 formalin-fixed, paraffin-embedded (FFPE) sections prepared from surgical tissue specimens, with ≥5% tumor cell content confirmed by H&E staining.
排除标准
- •Failure to meet any one of the requisite eligibility criteria specified in the inclusion criteria.
- •History of a concurrent or prior malignancy at other sites.
- •Failure to complete the planned cycles of neoadjuvant immunotherapy due to treatment-related toxicities.
- •Any other condition that, in the judgment of the investigator, renders the patient unsuitable for participation in this study.
结局指标
主要结局
Proportion of driver-alteration-positive patients detected by combined DNA+RNA testing
时间窗: through study completion, an average of 1 year
We selected patients with lung adenocarcinoma who had received preoperative neoadjuvant immunotherapy, did not achieve pathological complete response (pCR) after surgery, and had pre-treatment biopsy samples testing negative for EGFR and ALK alterations. Subsequent combined DNA/RNA next-generation sequencing (NGS) was performed using the 3DMed Onco™ Core Tissue Detection Kit. The proportion of patients with identified driver genomic alterations served as the primary endpoint of the study.
次要结局
- Comparative Analysis of Adjuvant Immunotherapy Efficacy Between Driver-Alteration-Positive and Negative Cohorts(through study completion, an average of 1 year)
- Stratified Analysis of EGFR/ALK-Positive Versus Other Driver-Alteration-Positive Subgroups(through study completion, an average of 1 year)
研究者
Dongsheng Yue
Chief Physician of Surgery
Tianjin Medical University Cancer Institute and Hospital