EUCTR2018-002572-41-IT进行中（未招募）1 期
A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) - PACIFIC-4/RTOG-3515
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 706
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age =18 years
- •2. Histologically or cytologically documented Stage I to II NSCLC, with clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive treatment with SBRT. Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy
- •3. Completion of SoC SBRT as definitive treatment prior to randomization
- •4. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, or 2
- •5. Life expectancy of at least 12 weeks
- •6. Body weight >30 kg
- •7. Submission of available tumor tissue sample
- •8. Adequate organ and marrow function required
- •9. Patients with central or peripheral lesions are eligible
- •10. Staging studies must be done within 10 weeks before randomization
- •11. Pulmonary Function Testing within 12 weeks of randomization
- •12. Patients with a history of metachronus stage I/II (T1-T3N0M0) NSCLC treated definitively with radiation, surgery only, or surgery with adjuvant chemotherapy in whom all treatments completed >1 year prior to randomization are eligible.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 406
排除标准
- •1. Mixed small cell and non-small cell cancer histology
- •2. History of allogeneic organ transplantation
- •3. History of another primary malignancy with exceptions
- •4. History of active primary immunodeficiency
- •5. Any unresolved toxicity National Cancer Institute (NCI) CTCAE Grade=2 from SBRT (Stereotactic Body Radiation Therapy)
研究者
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