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Durvalumab 对比安慰剂在早期未切除的非小细胞肺癌 (NSCLC) 患者中进行立体定向放疗 / 奥希替尼在 SBRT 后对携带 EGFR 突变的早期未切除 NSCLC 患者进行立体定向放疗 (PACIFIC-4)

2026年11月6日 更新者：AstraZeneca

Durvalumab 联合立体定向放射治疗 (SBRT) 治疗未切除的 I/II 期淋巴结阴性非小细胞癌患者的 III 期、随机、安慰剂对照、双盲、多中心、国际研究肺癌 (PACIFIC-4/RTOG-3515) SBRT 后的奥希替尼，针对未切除 I/II 期淋巴结阴性 NSCLC 患者的单组队列

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

Patients with Stage I/II lymph node negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1 to receive either Durvalumab + SoC SBRT or placebo + SoC SBRT.

The primary objective of main cohort is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS. Key secondary is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of Overall Survival (OS).

In addition, a study cohort with a sufficient number of patients harboring an EGFR-TKI sensitizing mutation, will receive Osimertinib treatment after completion of SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC. The primary objective of Osimertinib cohort is to assess efficacy of Osimertinib following SoC SBRT in terms of 4-year PFS. Key secondary objectives include safety, OS and efficacy of Osimertininb treatment with SBRT.

研究类型

介入性

注册 (实际的)

724

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100142
        • Research Site
      • Beijing、中国、100021
        • Research Site
      • Changchun、中国、130021
        • Research Site
      • Changsha、中国、410013
        • Research Site
      • Chengdu、中国、610042
        • Research Site
      • Fuzhou、中国、350005
        • Research Site
      • Hangzhou、中国、310022
        • Research Site
      • Hangzhou、中国、310002
        • Research Site
      • Hefei、中国、230031
        • Research Site
      • Jinan、中国、250117
        • Research Site
      • Nanjing、中国、210009
        • Research Site
      • Shanghai、中国、200032
        • Research Site
      • Shanghai、中国、200433
        • Research Site
      • Shanghai、中国、200030
        • Research Site
      • Shanghai、中国、200002
        • Research Site
      • Shenyang、中国、100003
        • Research Site
      • Suzhou、中国、215006
        • Research Site
      • Wenzhou、中国、325000
        • Research Site
      • Wuhan、中国、430022
        • Research Site
      • Wuhan、中国、430030
        • Research Site
      • Zhengzhou、中国、450008
        • Research Site
  • 以色列
      • Haifa、以色列、31096
        • Research Site
      • Jerusalem、以色列、91120
        • Research Site
      • Kfar Saba、以色列、95847
        • Research Site
      • Petah Tikva、以色列、49100
        • Research Site
      • Ramat Gan、以色列、52621
        • Research Site
      • Tel Aviv、以色列、64239
        • Research Site
  • 俄罗斯
      • Kazan, Tatarstan、俄罗斯、420029
        • Research Site
      • Moscow、俄罗斯、115478
        • Research Site
      • Moscow、俄罗斯、105229
        • Research Site
      • Moscow、俄罗斯、119421
        • Research Site
      • Saint Petersburg、俄罗斯、197758
        • Research Site
      • Ufa、俄罗斯、450054
        • Research Site
      • Yekaterinburg、俄罗斯、620905
        • Research Site
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 1Z2
        • Research Site
    • Ontario
      • London、Ontario、加拿大、N6A 5W9
        • Research Site
      • Toronto、Ontario、加拿大、M5G 2M9
        • Research Site
      • Toronto、Ontario、加拿大、M4N 3M5
        • Research Site
    • Quebec
      • Montreal、Quebec、加拿大、H2X 3E4
        • Research Site
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、06520
        • Research Site
      • Ankara、土耳其（türkiye）、06010
        • Research Site
      • Istanbul、土耳其（türkiye）、34214
        • Research Site
      • Izmir、土耳其（türkiye）、35340
        • Research Site
      • Kocaeli、土耳其（türkiye）、41400
        • Research Site
  • 巴西
      • Barretos、巴西、14784-400
        • Research Site
      • Porto Alegre、巴西、90110-270
        • Research Site
      • Recife、巴西、52010-075
        • Research Site
      • Rio de Janeiro、巴西、22271-110
        • Research Site
      • São Paulo、巴西、01327-001
        • Research Site
      • Volta Redonda、巴西、27258-000
        • Research Site
  • 希腊
      • Athens、希腊、11527
        • Research Site
      • Athens、希腊、11526
        • Research Site
      • Thessaloniki、希腊、55236
        • Research Site
  • 德国
      • Dresden、德国、01307
        • Research Site
      • Göttingen、德国、37075
        • Research Site
      • Halle、德国、06120
        • Research Site
      • Hanover、德国、30459
        • Research Site
      • Heidelberg、德国、69126
        • Research Site
      • Homburg、德国、66424
        • Research Site
      • Regensburg、德国、93053
        • Research Site
      • Trier、德国、54292
        • Research Site
  • 意大利
      • Florence、意大利、50134
        • Research Site
      • Genova、意大利、16132
        • Research Site
      • Milan、意大利、20132
        • Research Site
      • Orbassano、意大利、10043
        • Research Site
      • Padova、意大利、35128
        • Research Site
      • Pavia、意大利、27100
        • Research Site
      • Roma、意大利、00128
        • Research Site
      • Rozzano、意大利、20089
        • Research Site
  • 日本
      • Akashi-shi、日本、673-8558
        • Research Site
      • Bunkyō City、日本、113-8677
        • Research Site
      • Chūōku、日本、104-0045
        • Research Site
      • Fukuoka、日本、812-8582
        • Research Site
      • Hirosaki-shi、日本、036-8563
        • Research Site
      • Hiroshima、日本、734-8551
        • Research Site
      • Kobe、日本、650-0047
        • Research Site
      • Niigata、日本、951-8566
        • Research Site
      • Osaka、日本、541-8567
        • Research Site
      • Sakaishi、日本、591-8555
        • Research Site
      • Sapporo、日本、060-8648
        • Research Site
      • Sunto-gun、日本、411-8777
        • Research Site
      • Toyoake-shi、日本、470-1192
        • Research Site
      • Yokohama、日本、241-8515
        • Research Site
  • 比利时
      • Aalst、比利时、9300
        • Research Site
      • Charleroi、比利时、6060
        • Research Site
      • Edegem、比利时、2650
        • Research Site
      • Ghent、比利时、9000
        • Research Site
      • Leuven、比利时、3000
        • Research Site
  • 法国
      • Bron、法国、69677
        • Research Site
      • Dijon、法国、21079
        • Research Site
      • Lyon、法国、69317
        • Research Site
      • Nantes、法国、44202
        • Research Site
      • Pierre-Bénite、法国、69310
        • Research Site
      • Toulouse、法国、31000
        • Research Site
      • Villejuif、法国、94805
        • Research Site
  • 波兰
      • Bydgoszcz、波兰、85-796
        • Research Site
      • Elblag、波兰、02-300
        • Research Site
      • Gdansk、波兰、80-952
        • Research Site
      • Katowice、波兰、40-514
        • Research Site
      • Lodz、波兰、93-513
        • Research Site
      • Warsaw、波兰、02-781
        • Research Site
  • 波多黎各
      • Hato Rey、波多黎各、00917
        • Research Site
  • 澳大利亚
      • Clayton、澳大利亚、3168
        • Research Site
  • 美国
    • Alabama
      • Tuscaloosa、Alabama、美国、35401
        • Research Site
    • Arizona
      • Chandler、Arizona、美国、85224
        • Research Site
      • Phoenix、Arizona、美国、85004
        • Research Site
      • Tucson、Arizona、美国、85719
        • Research Site
    • California
      • Duarte、California、美国、91010
        • Research Site
      • Long Beach、California、美国、90806
        • Research Site
      • Los Angeles、California、美国、90095
        • Research Site
      • San Diego、California、美国、92123
        • Research Site
    • Delaware
      • Newark、Delaware、美国、10709
        • Research Site
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20010
        • Research Site
    • Florida
      • Bay Pines、Florida、美国、33744
        • Research Site
      • Jacksonville、Florida、美国、32256
        • Research Site
      • Miami Beach、Florida、美国、33140
        • Research Site
      • Orlando、Florida、美国、32804
        • Research Site
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Research Site
      • Atlanta、Georgia、美国、30342
        • Research Site
    • Illinois
      • Chicago、Illinois、美国、60612
        • Research Site
      • Chicago、Illinois、美国、60637
        • Research Site
      • Chicago、Illinois、美国、60611
        • Research Site
      • Decatur、Illinois、美国、62526
        • Research Site
      • Elmhurst、Illinois、美国、60126
        • Research Site
      • Naperville、Illinois、美国、60540
        • Research Site
    • Indiana
      • Fort Wayne、Indiana、美国、46845
        • Research Site
    • Iowa
      • Cedar Rapids、Iowa、美国、52403
        • Research Site
      • Iowa City、Iowa、美国、52242
        • Research Site
    • Kentucky
      • Elizabethtown、Kentucky、美国、42701
        • Research Site
      • Lexington、Kentucky、美国、40503
        • Research Site
      • Louisville、Kentucky、美国、40202
        • Research Site
    • Louisiana
      • Metairie、Louisiana、美国、70006
        • Research Site
      • New Orleans、Louisiana、美国、70121
        • Research Site
    • Maine
      • South Portland、Maine、美国、04106
        • Research Site
    • Maryland
      • Annapolis、Maryland、美国、21401
        • Research Site
      • Baltimore、Maryland、美国、21201
        • Research Site
      • Rosedale、Maryland、美国、21237
        • Research Site
      • Silver Spring、Maryland、美国、20910
        • Research Site
      • Towson、Maryland、美国、21204
        • Research Site
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Research Site
    • Michigan
      • Ann Arbor、Michigan、美国、48197
        • Research Site
      • Detroit、Michigan、美国、48201
        • Research Site
      • Royal Oak、Michigan、美国、48073
        • Research Site
    • Minnesota
      • Duluth、Minnesota、美国、55805
        • Research Site
      • Rochester、Minnesota、美国、55905
        • Research Site
    • Missouri
      • St Louis、Missouri、美国、63110
        • Research Site
    • Nebraska
      • Omaha、Nebraska、美国、68105
        • Research Site
    • Nevada
      • Las Vegas、Nevada、美国、89169
        • Research Site
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756
        • Research Site
    • New Jersey
      • Camden、New Jersey、美国、08103
        • Research Site
      • Paramus、New Jersey、美国、07652
        • Research Site
    • New York
      • Albany、New York、美国、12206
        • Research Site
      • East Syracuse、New York、美国、13057
        • Research Site
      • New Hyde Park、New York、美国、11042
        • Research Site
      • New York、New York、美国、10016
        • Research Site
      • Rochester、New York、美国、14642
        • Research Site
      • Stony Brook、New York、美国、11794
        • Research Site
      • Syracuse、New York、美国、13210
        • Research Site
      • The Bronx、New York、美国、10461
        • Research Site
      • The Bronx、New York、美国、10467
        • Research Site
    • North Carolina
      • Winston-Salem、North Carolina、美国、27157
        • Research Site
    • North Dakota
      • Grand Forks、North Dakota、美国、58201
        • Research Site
    • Ohio
      • Akron、Ohio、美国、44304
        • Research Site
      • Blue Ash、Ohio、美国、45242
        • Research Site
      • Cincinnati、Ohio、美国、45219
        • Research Site
      • Cleveland、Ohio、美国、44106
        • Research Site
    • Oregon
      • Portland、Oregon、美国、97213
        • Research Site
      • Portland、Oregon、美国、97210
        • Research Site
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • Research Site
      • Pittsburgh、Pennsylvania、美国、15212
        • Research Site
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Research Site
    • South Dakota
      • Sioux Falls、South Dakota、美国、57105
        • Research Site
      • Watertown、South Dakota、美国、57201
        • Research Site
    • Texas
      • Austin、Texas、美国、78745
        • Research Site
      • Dallas、Texas、美国、75235
        • Research Site
      • Houston、Texas、美国、77030
        • Research Site
      • Sherman、Texas、美国、75090
        • Research Site
    • Vermont
      • Burlington、Vermont、美国、05401
        • Research Site
    • Virginia
      • Richmond、Virginia、美国、23249
        • Research Site
    • Washington
      • Bellingham、Washington、美国、98225
        • Research Site
      • Seattle、Washington、美国、98195
        • Research Site
      • Spokane Valley、Washington、美国、99216
        • Research Site
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Research Site
  • 英国
      • Birmingham、英国、B9 5SS
        • Research Site
      • Leeds、英国、LS9 7TF
        • Research Site
      • London、英国、EC1A 7BE
        • Research Site
      • Manchester、英国、M20 4BX
        • Research Site
  • 荷兰
      • Amsterdam、荷兰、1081 HV
        • Research Site
      • Groningen、荷兰、9713 GZ
        • Research Site
      • Utrecht、荷兰、3584 CX
        • Research Site
  • 西班牙
      • Badajoz、西班牙、6006
        • Research Site
      • Barcelona、西班牙、08041
        • Research Site
      • L'Hospitalet de Llobregat、西班牙、08907
        • Research Site
      • Madrid、西班牙、28034
        • Research Site
      • Madrid、西班牙、28046
        • Research Site
      • Madrid、西班牙、28041
        • Research Site
      • Madrid、西班牙、28040
        • Research Site
      • Málaga、西班牙、29010
        • Research Site
      • San Sebastián、西班牙、20014
        • Research Site
      • Santiago de Compostela、西班牙、15706
        • Research Site
      • Seville、西班牙、41013
        • Research Site
      • Valencia、西班牙、46010
        • Research Site
      • Zaragoza、西班牙、50009
        • Research Site
  • 韩国
      • Cheongju-si、韩国、28644
        • Research Site
      • Goyang-si、韩国、10408
        • Research Site
      • Gyeonggi-do、韩国、13620
        • Research Site
      • Seoul、韩国、03722
        • Research Site
      • Seoul、韩国、05505
        • Research Site
      • Seoul、韩国、06351
        • Research Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 130年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Main Cohort Key Inclusion Criteria:

  1. Age ≥18 years
  2. Planned SoC SBRT as definitive treatment
  3. World Health Organization (WHO)/ECOG PS of 0, 1 or 2
  4. Life expectancy of at least 12 weeks
  5. Body weight >30 kg
  6. Submission of tumor tissue sample if available
  7. Adequate organ and marrow function required
  8. Patients with central or peripheral lesions are eligible
  9. Staging studies must be done during screening (PET-CT within 10 weeks)
  10. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions

Main Cohort Key Exclusion Criteria:

  1. Mixed small cell and non-small cell cancer
  2. History of allogeneic organ transplantation
  3. History of another primary malignancy with exceptions
  4. History of active primary immunodeficiency
  5. Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
  6. Prior exposure to immune-mediated therapy with exceptions

Osimertinib Cohort Key Inclusion Criteria

  1. Age ≥18 years
  2. Planned SoC SBRT as definitive treatment
  3. WHO/ECOG PS of 0, 1, or 2
  4. Patients with central or peripheral lesions are eligible
  5. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
  6. Staging studies must be done during screening (PET-CT within 10 weeks)
  7. Submission of tumor tissue sample if available
  8. Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
  9. Adequate bone marrow reserve or organ function required
  10. Female patients should be using highly effective contraceptive measures
  11. Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation

Osimertinib Cohort Key Exclusion Criteria

  1. Mixed small cell and non-small cell cancer

  2. Patients with known or increased risk factor for QTc prolongation

  3. Treatment with any of the following:

    • Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation
    • Prior treatment with neoadjuvant or adjuvant EGFR TKI
    • Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4

  4. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib

  5. Any of the following cardiac criteria

    • Mean resting corrected QT interval >470 msec, obtained from 3 ECGs
    • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
    • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval
    • Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：SoC SBRT + Durvalumab Therapy (Main Cohort)

SBRT

Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 26 cycles or until progression or other discontinuation criteria are met.
药品：Durvalumab

Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 26 cycles or until progression or other discontinuation criteria are met.

其他名称：
  • MEDI4736
安慰剂比较：SoC SBRT + Placebo Therapy (Main Cohort)

SBRT

Placebo (matching placebo for infusion) every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.
其他：Placebo

Matching placebo for infusion every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.
实验性的：SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, open-label separate cohort)

SBRT

Osimertinib 80mg every day [qd] for oral administration up to 36 months or until progression. Osimertinib treatment should start within 7 to 14 days after completion of SBRT
药品：(Osimertinib cohort, single-arm, open-label separate cohort)

Osimertinib 80 mg every day [qd] orally for up to 36 months or until progression or other discontinuation criteria are met. Osimertinib treatment should start from 7 to 14 days after completion of SBRT

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC
大体时间：from randomization up to 6 years

Main Cohort
from randomization up to 6 years
4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria
大体时间：from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years

次要结果测量

结果测量
措施说明
大体时间
Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC
大体时间：from randomization up to 6 years

Main Cohort
from randomization up to 6 years
Overall Survival (OS)
大体时间：from randomization up to 7 years

Main Cohort
from randomization up to 7 years
Concentration of durvalumab in serum such as peak concentration and trough
大体时间：12 weeks after last dose

Main Cohort
12 weeks after last dose
Detection of ADA neutralising antibodies titers
大体时间：up to 6 months after last dose

Main Cohort
up to 6 months after last dose
Health-related quality of life in patients treated with durvalumab with SoC SBRT compared to placebo with SoC SBRT using the EORTC QLQ-C30
大体时间：from randomization up to 7 years

Main Cohort
from randomization up to 7 years
Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1
大体时间：at 24 months following randomization

Main Cohort
at 24 months following randomization
Time to progression (TTP) assessed by BICR according to RECIST 1.1
大体时间：from randomization up to 6 years

Main Cohort
from randomization up to 6 years
Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1
大体时间：from randomization up to 6 years

Main Cohort
from randomization up to 6 years
Time from randomisation to second progression (PFS2) as defined by local standard clinical practice
大体时间：from randomization up to 7 years

Main Cohort
from randomization up to 7 years
Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of Durvalumab with SoC SBRT compared to placebo with SoC SBRT
大体时间：up to 3 months after last dose

Main Cohort
up to 3 months after last dose
Assessment of AEs by CTCAE v 5.0 as measures of the safety, tolerability and compliance of osimertinib with SoC SBRT therapy
大体时间：Up to 35 days after last dose

Osimertinib Cohort
Up to 35 days after last dose
WHO performance status
大体时间：from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
ECG QT interval
大体时间：Up to 156 weeks of treatment or treatment discontinuation

Osimertinib Cohort
Up to 156 weeks of treatment or treatment discontinuation
Overall Survival
大体时间：from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
Time To Progression (TTP)
大体时间：from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
Time to CNS progression
大体时间：from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
PFS2
大体时间：from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
Site(s) of disease progression
大体时间：from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
PFS by ICR using RECIST 1.1
大体时间：from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years

其他结果措施

结果测量
措施说明
大体时间
Lung cancer mortality
大体时间：from treatment start up to 5 years

Osimertinib Cohort
from treatment start up to 5 years
Lung Cancer Mortality
大体时间：from randomization Up to 5 years

Main Cohort
from randomization Up to 5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年3月6日

初级完成 (估计的)

2028年10月31日

研究完成 (估计的)

2028年10月31日

研究注册日期

首次提交

2019年1月25日

首先提交符合 QC 标准的

2019年2月5日

首次发布 (实际的)

2019年2月6日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • D9103C00001
  • 2018 (美国 NIH 拨款/合同)
  • 2018-002572-41 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共享时间框架

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共享访问标准

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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