Neoadjuvant Immunotherapy in Advanced NSCLC
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Major Pathological Response
研究概览
简要总结
A number of clinical trials have demonstrated the efficacy of immunotherapy prior as neoadjuvant therapy. This study evaluates whether said neoadjuvant immunotherapy may improve improve progression free survival in NSCLC. One such example would be to evaluate either single agent or an immunotherapy combination with chemotherapy. Following this, analysis of biomarkers will be conducted to provide personalization in one's regimen.
详细描述
A number of clinical trials have demonstrated the efficacy of immunotherapy prior as neoadjuvant therapy. This study evaluates whether said neoadjuvant immunotherapy may improve improve progression free survival in NSCLC. [The Power Life Sciences Investigative Team](https://www.withpower.com) is running a study to evaluate either single agent or an immunotherapy combination with chemotherapy. Patients can contact a site administrator via the information below, or enroll directly via <a href="https://www.withpower.com/trial/phase-4-2019-e67c1"\>https://www.withpower.com/trial/phase-4-2019-e67c1\</a>. Following this, analysis of biomarkers will be conducted to provide personalization in one's regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •>= 18 Years of Age
- •Informed consent is provided
- •Histologically confirmed resectable non-small cell lung cancer with stage II-IIIA (TNM 8th edition)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Epidermal growth factor receptor (EGFR) mutation negative and anaplastic lymphoma kinase (ALK) translocation negative
排除标准
- •EGFR mutation positive and ALK translocation positive
- •Active central nervous system (CNS) metastases
- •Autoimmune diseases
- •Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
- •Patients with interstitial lung disease will not be included if they have symptomatic interstitial lung disease (ILD) - Grade 3-4
- •Women who are breast feeding or pregnant
- •Sexually active women or men of childbearing potential who are not willing to use an effective contraceptive method during the study
结局指标
主要结局
Major Pathological Response
时间窗: 12 Weeks
To evaluate the major pathological response (MPR) rate of participants
次要结局
- Objective Response Rate(12 Weeks)
- Progression Free Survival(12 Weeks)
- MPR based on diverse PD-L1 expression(12 Weeks)