EUCTR2018-002932-26-FR进行中（未招募）1 期
A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination with Novel Agents in Subjects with Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST) - NeoCOAST
MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC0 个研究点目标入组 160 人开始时间: 2019年2月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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. Cytologically and/or histologically-documented NSCLC
- •(a) Stage I (> 2 cm) to IIIA (For subjects with N2 disease, only those with 1 single nodal station = 3 cm are eligible) NSCLC
- •(b) Amenable to complete surgical resection
- •(c) Have not received any other therapy for this condition
- •2. Age =18 years old
- •3. Predicted FEV1 = 50%
- •4. Predicted DLCO = 50%
- •5. ECOG 0 or 1
- •6. Adequate organ function
- •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 96
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •1. Subjects with small-cell lung cancer or mixed small-cell lung cancer
- •2. Subjects who require or may require pneumonectomy
- •3. Prior treatment with PD-L1, PD-L1, or CTLA-4 inhibitors
- •4. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
- •5. Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:
- •a. Subjects with vitiligo or alopecia
- •b. Subjects with hypothyroidism on hormone replacement
- •c. Any chronic skin condition that does not require systemic therapy
- •d. Subjects without active disease in the last 5 years may be included but only after consultation with the study physician
- •e. Subjects with celiac disease controlled by diet alone
- •6. Pregnant or breast-feeding female
- •7. Major surgical procedure within prior 30 days
- •8. History of active primary immunodeficiency
- •9. Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
- •10. QTc interval (QTc) = 470 ms
- •11. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent
- •12. Receipt of live attenuated vaccination within 30 days prior to study entry
- •13. History of another primary malignancy except for:
- •a. Curative-treated malignancy with no known active disease > 2 years before enrollment on the study
- •b. Curative-treated non-melanoma skin cancer and/or carcinoma in-situ
研究者
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