2024-515321-29-00招募中3 期
A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Given Concurrently with Platinum-based Chemoradiation Therapy in Patients with Locally Advanced, Unresectable Non-small Cell Lung Cancer (Stage III) (PACIFIC2)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- PFS using BICR assessments according to RECIST 1.1
研究概览
简要总结
To assess the efficacy of durvalumab + standard of care (SoC) chemoradiation therapy (CRT) compared with placebo + SoC CRT in terms of Progression Free Survival (PFS).
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment period
- 盲法
- Double (Analyst, Investigator, Monitor, Subject, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •'- Subjects with histologically- or cytologically-documented NSCLC - Locally advanced or unresectable (Stage III) NSCLC - World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment and randomization. - At least one measurable lesion, not previously irradiated - Must have a life expectancy of at least 12 weeks at randomization
排除标准
- •'- Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs. - Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies, excluding therapeutic anticancer vaccines. - History of allogeneic organ transplantation - Active or prior documented autoimmune or inflammatory disorders - Uncontrolled intercurrent illness - History of another primary malignancy / leptomeningeal carcinomatosis / active primary immunodeficiency - Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus - Mixed small cell and NSCLC histology. - Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labelling - Known allergy or hypersensitivity to any of the IPs or any of the IP excipients. - Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume. - Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors. Patients with T4 lesions that invade major vascular structures such as pulmonary artery or cardiac tissues are also not eligible.
结局指标
主要结局
PFS using BICR assessments according to RECIST 1.1
PFS using BICR assessments according to RECIST 1.1
次要结局
- OS and OS24 ORR, Rate of CR, DoR, DCR, and TTDM using BICR assessments according to RECIST 1.1 PFS2 as defined by local standard clinical practice Concentration of durvalumab in blood (such as peak and trough concentration, as data allow; sparse sampling) ADA (confirmatory results: positive or negative; titers [ADA neutralizing antibodies will also be assessed])
- Presence of ADA for durvalumab (confirmatory results: positive or negative; titers); EORTC QLQ-C30 and QLQ-LC13: Change in symptoms, functioning, and global health status/QoL Safety objective: to assess the safety and tolerability profile of durvalumab + SoC CRT compared with placebo + SoC CRT
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (4)
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