NCT06003075终止2 期
Phase II Study of Induction Platinum Doublet in Combination With Nivolumab Followed by Surgery or Concurrent Chemoradiation in Unresectable Stage IIIA-C Non-small Cell Lung Cancer (NSCLC)
Ralph G Zinner1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2023年12月13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
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Response Rate After Induction
研究概览
简要总结
The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Squamous and non-squamous non-small cell lung cancer that is at baseline, unresectable stage IIIA-IIIC (8th edition AJCC) and not previously treated
- •PD-L1 level needs to be measured with values 0-100% eligible
- •EGFR/ALK/ROS1 Wild Type or unknown genetic alterations in these genes
- •ECOG Performance Status ≤ 1
- •Adequate organ and marrow function
- •Adequate pulmonary reserve (e.g., FVC, FEV1, TLC, FRC, and DLCO) capable of tolerating the proposed lung resection
- •Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
- •For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- •Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
- •Clinical risk assessment of cardiac function using the New York Heart Association Functional Classification class 2B or better
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients who have participated in a study with an investigational agent or device within 2 weeks of enrollment
- •Any prior radiotherapy to the lung
- •Any prior treatment for NSCLC
- •Any prior therapy with anti-PD-1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- •Any history of a severe hypersensitivity reaction to any monoclonal antibody
- •Any history of allergy to the study drug components
- •primary tumors involving the esophagus
- •pancoast tumors
- •Patients cannot have primary tumors which would remain unresectable
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nivolumab or other agents used in study
- •Any active or history of autoimmune disease (including any history of inflammatory bowel disease), or history of syndrome that required systemic steroids or immunosuppressive medications
- •Ongoing requirement for systemic corticosteroids greater than the equivalent of prednisone 10mg
- •previous malignancies
- •history of interstitial lung disease
- •Patients requiring continuous supplemental oxygen
- •Use of any live vaccines against infectious diseases (e.g., influenza, varicella. etc.) within 4 weeks (28 days) of initiation of study therapy
- •Active systemic infection requiring therapy
- •Patients with uncontrolled intercurrent illness
- •Patients with psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant or lactating women
研究组 & 干预措施
Combination Chemotherapy and Nivolumab and Surgery
Experimental
Patients with lung cancer receiving combination therapy with surgery
干预措施: Nivolumab and Chemotherapy (Combination Product)
Combination Chemotherapy and Nivolumab and Surgery
Experimental
Patients with lung cancer receiving combination therapy with surgery
干预措施: Nivolumab (Drug)
Combination Chemotherapy and Nivolumab and Surgery
Experimental
Patients with lung cancer receiving combination therapy with surgery
干预措施: Post Induction Surgery (Procedure)
Combination Chemotherapy and Nivolumab and Surgery
Experimental
Patients with lung cancer receiving combination therapy with surgery
干预措施: Post Induction XRT (Radiation)
Combination Chemotherapy and Nivolumab and Radiation
Experimental
Patients with lung cancer receiving combination therapy with radiation
干预措施: Nivolumab and Chemotherapy (Combination Product)
Combination Chemotherapy and Nivolumab and Radiation
Experimental
Patients with lung cancer receiving combination therapy with radiation
干预措施: Nivolumab (Drug)
Combination Chemotherapy and Nivolumab and Radiation
Experimental
Patients with lung cancer receiving combination therapy with radiation
干预措施: Post Induction XRT (Radiation)
结局指标
主要结局
Response Rate After Induction
时间窗: 9 weeks
post induction radiographic response by cat scan
次要结局
- Major Pathological Response (MPR)(post surgery, approximately 10 weeks)
- Progression Free Survival (PFS)(2 years)
- Overall Survival (OS)(2 years)
- Change in Toxicity(through study completion, up to 18 months)
- Percent of Participants Receiving Surgery(date of surgery, approximately 10 weeks)
- Pathologic Complete Response (pCR)(post surgery, approximately 10 weeks)
- Change in Patient-reported Quality of Life as Measured by FACT-TOI(through study completion, up to 18 months)
研究者
Ralph G Zinner
Professor
University of Kentucky
研究点 (1)
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