NCT04992780招募中2 期
A Randomized Phase II Trial of Hypo-fractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction Versus (VS) Standard-Fractionated IMRT, Concurrent With Carboplatin/Paclitaxel and Followed by Consolidation Durvalumab, for Subjects With Stage 2A/B Non-Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- Locoregional control (LRC)
研究概览
简要总结
The hypothesis for this study is that hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with concurrent carboplatin and paclitaxel, followed by maintenance durvalumab will improve locoregional control at 18 months by 10% compared to standard-fractionated chemo-IMRT/durvalumab. A modest improvement in locoregional control (LRC) was selected as a target which could merit further study of this hypofractionated IMRT regimen in a Phase III trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- •Males and females age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
- •Measurable disease by RECIST 1.1
- •Women of childbearing potential must have a negative serum pregnancy test within one month prior to initiating treatment
- •Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC)
- •No Positron Emission Tomography (PET)/CT evidence of metastatic disease
- •An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons
- •If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible
- •Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for 90 days following completion of therapy
- •Adequate organ function per laboratory results
排除标准
- •Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
- •Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- •Evidence of severe or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator
- •Is pregnant or breastfeeding
- •Active connective tissue disorders, such as active lupus or scleroderma
- •Known Acquired Immune Deficiency (HIV (+)/AIDS)
- •Has a known allergic reaction to any excipient contained in the study drug formulations
- •Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
- •Prior thoracic radiotherapy
结局指标
主要结局
Locoregional control (LRC)
时间窗: From enrollment for up to 7.5 years
RECIST 1.1
次要结局
- Progression free survival (PFS)(From enrollment for up to 7.5 years)
- Measuring the Impact of Treatment on the Quality of life (QOL)(From enrollment for up to 7.5 years)
- Overall survival (OS)(From enrollment for up to 7.5 years)
- Acute toxicities(From enrollment for up to 7.5 years)
- Late toxicities(From enrollment for up to 7.5 years)
研究者
研究点 (12)
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