NCT06275360招募中2 期
Repositioning Immunotherapy in Veterans With Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- Progression-free survival
研究概览
简要总结
This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC.
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
- •Participants must be more than 18 years of age.
- •Patient must have a performance status of 0-1 (ECOG Performance Scale).
- •Patient must be a candidate for concurrent chemoradiation.
- •Unresectable Stage III NSCLC as assessed by investigator or multidisciplinary tumor board assessment
- •PD-L1 tumor expression greater than or equal to 1%
- •Presence of measurable disease according to RECIST v1.1
- •Adequate organ function
- •Available tissue (archival FFPE preferred) with adequate tumor content ( 20% tumor cellularity).
排除标准
- •Active autoimmune disease that has requires immunosuppressive therapy in the previous year.
- •Uncontrolled primary or acquired immunodeficiency (including HIV)
- •Baseline corticosteroid usage (>10 mg prednisone or equivalent daily) aside from supportive medication use.
- •Tumor with known EGFR, ALK, ROS1, MET or RET mutations/fusions.
- •Presence of significant comorbidities precluding participation in a clinical study as determined by investigator.
- •Prior thoracic radiotherapy or prior systemic treatment for stage IIIB/IV NSCLC
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment.
- •Has a known history of active TB (Bacillus Tuberculosis)
- •Has known active Hepatitis B or Hepatitis C.
- •Has received a live vaccine within 30 days of enrollment.
- •Known diagnosis of Interstitial Lung Disease
- •Inability to provide informed consent.
研究组 & 干预措施
Chemoimmunotherapy followed by radiotherapy
Experimental
Nivolumab (Opdivo) + plus platinum-doublet chemotherapy followed by radiotherapy
干预措施: Nivolumab (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Approximately two years after enrollment
Defined as the time from start of treatment to radiographic/clinical progression (per irRECIST1.1), or death from any cause, whichever occurs first.
Treatment Tolerance
时间窗: Approximately three years after enrollment
Proportion of patients able to complete prescribed treatment course (all planned cycles of systemic therapy and all fractions of radiotherapy).
次要结局
- Overall survival(Approximately two years after enrollment)
- Adverse Events(Approximately two years after enrollment)
- Best overall response rate (BOR)(Approximately two years after enrollment)
研究者
研究点 (7)
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