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LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

2017年11月3日 更新者：Boehringer Ingelheim

A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

617

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

  • 丹麦
      • København Ø、丹麦
        • 1200.131.04551 Boehringer Ingelheim Investigational Site
  • 乌克兰
      • Kharkiv、乌克兰
        • 1200.131.03854 Boehringer Ingelheim Investigational Site
      • Kiev、乌克兰
        • 1200.131.03851 Boehringer Ingelheim Investigational Site
  • 以色列
      • Haifa、以色列
        • 1200.131.97251 Boehringer Ingelheim Investigational Site
      • Petach Tikva、以色列
        • 1200.131.97253 Boehringer Ingelheim Investigational Site
  • 俄罗斯联邦
      • Moscow、俄罗斯联邦
        • 1200.131.00759 Boehringer Ingelheim Investigational Site
      • Omsk、俄罗斯联邦
        • 1200.131.00753 Boehringer Ingelheim Investigational Site
      • Pyatigorsk、俄罗斯联邦
        • 1200.131.00760 Boehringer Ingelheim Investigational Site
      • Pyatigorsk、俄罗斯联邦
        • 1200.131.00761 Boehringer Ingelheim Investigational Site
      • St. Petersburg、俄罗斯联邦
        • 1200.131.00763 Boehringer Ingelheim Investigational Site
      • Ufa、俄罗斯联邦
        • 1200.131.00755 Boehringer Ingelheim Investigational Site
      • Ufa、俄罗斯联邦
        • 1200.131.00762 Boehringer Ingelheim Investigational Site
  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大
        • 1200.131.00152 Boehringer Ingelheim Investigational Site
    • Ontario
      • Toronto、Ontario、加拿大
        • 1200.131.00157 Boehringer Ingelheim Investigational Site
      • Windsor、Ontario、加拿大
        • 1200.131.00151 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal、Quebec、加拿大
        • 1200.131.00153 Boehringer Ingelheim Investigational Site
      • Montreal、Quebec、加拿大
        • 1200.131.00154 Boehringer Ingelheim Investigational Site
      • Montreal、Quebec、加拿大
        • 1200.131.00155 Boehringer Ingelheim Investigational Site
  • 匈牙利
      • Budapest、匈牙利
        • 1200.131.03651 Boehringer Ingelheim Investigational Site
      • Budapest、匈牙利
        • 1200.131.03652 Boehringer Ingelheim Investigational Site
      • Budpest、匈牙利
        • 1200.131.03656 Boehringer Ingelheim Investigational Site
      • Debrecen、匈牙利
        • 1200.131.03654 Boehringer Ingelheim Investigational Site
      • Kecskemet、匈牙利
        • 1200.131.03655 Boehringer Ingelheim Investigational Site
  • 印度
      • Ahmadabad、印度
        • 1200.131.09178 Boehringer Ingelheim Investigational Site
      • Bangalore、印度
        • 1200.131.09165 Boehringer Ingelheim Investigational Site
      • Bikaner、印度
        • 1200.131.09152 Boehringer Ingelheim Investigational Site
      • Chennai、印度
        • 1200.131.09163 Boehringer Ingelheim Investigational Site
      • Chennai、印度
        • 1200.131.09173 Boehringer Ingelheim Investigational Site
      • Delhi、印度
        • 1200.131.09179 Boehringer Ingelheim Investigational Site
      • Gurgaon、印度
        • 1200.131.09170 Boehringer Ingelheim Investigational Site
      • Hyderabad、印度
        • 1200.131.09180 Boehringer Ingelheim Investigational Site
      • Jaipur、印度
        • 1200.131.09172 Boehringer Ingelheim Investigational Site
      • Karamsad,Anand, Gujarat、印度
        • 1200.131.09176 Boehringer Ingelheim Investigational Site
      • Madurai, Tamil Nadu、印度
        • 1200.131.09162 Boehringer Ingelheim Investigational Site
      • Mazagaon, Mumbai、印度
        • 1200.131.09175 Boehringer Ingelheim Investigational Site
      • New Delhi、印度
        • 1200.131.09151 Boehringer Ingelheim Investigational Site
      • Pune、印度
        • 1200.131.09164 Boehringer Ingelheim Investigational Site
      • Vishakapatnam、印度
        • 1200.131.09159 Boehringer Ingelheim Investigational Site
  • 埃及
      • Alexandria、埃及
        • 1200.131.2052 Boehringer Ingelheim Investigational Site
  • 墨西哥
      • Mexico、墨西哥
        • 1200.131.05252 Boehringer Ingelheim Investigational Site
  • 奥地利
      • Leoben、奥地利
        • 1200.131.04353 Boehringer Ingelheim Investigational Site
      • Linz、奥地利
        • 1200.131.04357 Boehringer Ingelheim Investigational Site
      • Salzburg、奥地利
        • 1200.131.04355 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 1200.131.04351 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 1200.131.04359 Boehringer Ingelheim Investigational Site
  • 巴西
      • Barretos、巴西
        • 1200.131.05554 Boehringer Ingelheim Investigational Site
      • Jau、巴西
        • 1200.131.05555 Boehringer Ingelheim Investigational Site
      • Passo Fundo、巴西
        • 1200.131.05557 Boehringer Ingelheim Investigational Site
      • Porto Alegre、巴西
        • 1200.131.05553 Boehringer Ingelheim Investigational Site
      • Sao Paulo、巴西
        • 1200.131.05551 Boehringer Ingelheim Investigational Site
      • Sao Paulo、巴西
        • 1200.131.05556 Boehringer Ingelheim Investigational Site
  • 希腊
      • Chaidari、希腊
        • 1200.131.03054 Boehringer Ingelheim Investigational Site
      • Thessaloniki、希腊
        • 1200.131.03052 Boehringer Ingelheim Investigational Site
  • 德国
      • Essen、德国
        • 1200.131.04954 Boehringer Ingelheim Investigational Site
      • Freiburg、德国
        • 1200.131.04961 Boehringer Ingelheim Investigational Site
      • Hannover、德国
        • 1200.131.04953 Boehringer Ingelheim Investigational Site
      • Jena、德国
        • 1200.131.04956 Boehringer Ingelheim Investigational Site
      • Kaiserslautern、德国
        • 1200.131.04959 Boehringer Ingelheim Investigational Site
      • Leipzig、德国
        • 1200.131.04951 Boehringer Ingelheim Investigational Site
      • Rostock、德国
        • 1200.131.04957 Boehringer Ingelheim Investigational Site
      • Trier、德国
        • 1200.131.04964 Boehringer Ingelheim Investigational Site
      • Ulm、德国
        • 1200.131.04963 Boehringer Ingelheim Investigational Site
      • Villingen-Schwenningen、德国
        • 1200.131.04962 Boehringer Ingelheim Investigational Site
  • 意大利
      • Confreria (CN)、意大利
        • 1200.131.03957 Boehringer Ingelheim Investigational Site
      • Milano、意大利
        • 1200.131.03951 Boehringer Ingelheim Investigational Site
      • Milano、意大利
        • 1200.131.03955 Boehringer Ingelheim Investigational Site
      • Milano、意大利
        • 1200.131.03960 Boehringer Ingelheim Investigational Site
  • 捷克语
      • Brno、捷克语
        • 1200.131.04254 Boehringer Ingelheim Investigational Site
      • Praha 5、捷克语
        • 1200.131.04253 Boehringer Ingelheim Investigational Site
      • Praha 8、捷克语
        • 1200.131.04251 Boehringer Ingelheim Investigational Site
  • 日本
      • Aichi, Nagoya、日本
        • 1200.131.08156 Boehringer Ingelheim Investigational Site
      • Chiba, Kashiwa、日本
        • 1200.131.08153 Boehringer Ingelheim Investigational Site
      • Hokkaido, Sapporo、日本
        • 1200.131.08151 Boehringer Ingelheim Investigational Site
      • Hyogo, Akashi、日本
        • 1200.131.08161 Boehringer Ingelheim Investigational Site
      • Hyogo, Kobe、日本
        • 1200.131.08157 Boehringer Ingelheim Investigational Site
      • Kanagawa, Isehara、日本
        • 1200.131.08159 Boehringer Ingelheim Investigational Site
      • Miyagi, Natori、日本
        • 1200.131.08164 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka、日本
        • 1200.131.08160 Boehringer Ingelheim Investigational Site
      • Shizuoka, Sunto-gun、日本
        • 1200.131.08155 Boehringer Ingelheim Investigational Site
      • Tochigi, Shimotsuke、日本
        • 1200.131.08152 Boehringer Ingelheim Investigational Site
      • Tokyo, Koto-ku、日本
        • 1200.131.08163 Boehringer Ingelheim Investigational Site
      • Tokyo, Meguro-ku、日本
        • 1200.131.08154 Boehringer Ingelheim Investigational Site
  • 智利
      • Vina De Mar、智利
        • 1200.131.05652 Boehringer Ingelheim Investigational Site
      • Vina del Mar、智利
        • 1200.131.05651 Boehringer Ingelheim Investigational Site
  • 比利时
      • Brussel、比利时
        • 1200.131.03259 Boehringer Ingelheim Investigational Site
      • Charleroi、比利时
        • 1200.131.03256 Boehringer Ingelheim Investigational Site
      • Hasselt、比利时
        • 1200.131.03255 Boehringer Ingelheim Investigational Site
      • Kortrijk、比利时
        • 1200.131.03253 Boehringer Ingelheim Investigational Site
      • Liège、比利时
        • 1200.131.03252 Boehringer Ingelheim Investigational Site
      • Liège、比利时
        • 1200.131.03254 Boehringer Ingelheim Investigational Site
      • Namur、比利时
        • 1200.131.03258 Boehringer Ingelheim Investigational Site
  • 法国
      • Le Havre、法国
        • 1200.131.03353 Boehringer Ingelheim Investigational Site
      • Marseille Cedex 5、法国
        • 1200.131.03362 Boehringer Ingelheim Investigational Site
      • Nice cedex 2、法国
        • 1200.131.03359 Boehringer Ingelheim Investigational Site
      • Orléans Cedex 2、法国
        • 1200.131.03365 Boehringer Ingelheim Investigational Site
      • Pierre-Bénite、法国
        • 1200.131.03355 Boehringer Ingelheim Investigational Site
      • Rouen、法国
        • 1200.131.03367 Boehringer Ingelheim Investigational Site
      • Saint Cloud、法国
        • 1200.131.03370 Boehringer Ingelheim Investigational Site
      • Saint Herblain Cedex、法国
        • 1200.131.03354 Boehringer Ingelheim Investigational Site
      • Saint Priest en Jarez、法国
        • 1200.131.03369 Boehringer Ingelheim Investigational Site
      • Salouel、法国
        • 1200.131.03366 Boehringer Ingelheim Investigational Site
      • Tours、法国
        • 1200.131.03356 Boehringer Ingelheim Investigational Site
      • Villejuif Cedex、法国
        • 1200.131.03357 Boehringer Ingelheim Investigational Site
  • 澳大利亚
    • Queensland
      • Wooloongabba、Queensland、澳大利亚
        • 1200.131.06151 Boehringer Ingelheim Investigational Site
  • 瑞典
      • Göteborg、瑞典
        • 1200.131.04652 Boehringer Ingelheim Investigational Site
      • Stockholm、瑞典
        • 1200.131.04651 Boehringer Ingelheim Investigational Site
  • 瑞士
      • Basel、瑞士
        • 1200.131.04151 Boehringer Ingelheim Investigational Site
      • Bern、瑞士
        • 1200.131.04152 Boehringer Ingelheim Investigational Site
  • 美国
    • Arkansas
      • Little Rock、Arkansas、美国
        • 1200.131.00171 Boehringer Ingelheim Investigational Site
    • California
      • Orange、California、美国
        • 1200.131.00181 Boehringer Ingelheim Investigational Site
    • Colorado
      • Aurora、Colorado、美国
        • 1200.131.00177 Boehringer Ingelheim Investigational Site
    • Connecticut
      • New Haven、Connecticut、美国
        • 1200.131.00185 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore、Maryland、美国
        • 1200.131.00173 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston、Massachusetts、美国
        • 1200.131.00176 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha、Nebraska、美国
        • 1200.131.00182 Boehringer Ingelheim Investigational Site
    • New Hampshire
      • Lebanon、New Hampshire、美国
        • 1200.131.00175 Boehringer Ingelheim Investigational Site
    • New York
      • Stony Brook、New York、美国
        • 1200.131.00179 Boehringer Ingelheim Investigational Site
      • The Bronx、New York、美国
        • 1200.131.00188 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Winston-Salem、North Carolina、美国
        • 1200.131.10200 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国
        • 1200.131.00172 Boehringer Ingelheim Investigational Site
    • Texas
      • San Antonio、Texas、美国
        • 1200.131.00184 Boehringer Ingelheim Investigational Site
    • Washington
      • Spokane Valley、Washington、美国
        • 1200.131.00198 Boehringer Ingelheim Investigational Site
      • Wenatchee、Washington、美国
        • 1200.131.00183 Boehringer Ingelheim Investigational Site
  • 芬兰
      • Turku、芬兰
        • 1200.131.35851 Boehringer Ingelheim Investigational Site
  • 英国
      • Denbighshire、英国
        • 1200.131.04456 Boehringer Ingelheim Investigational Site
      • Edinburgh、英国
        • 1200.131.04455 Boehringer Ingelheim Investigational Site
      • Exeter、英国
        • 1200.131.04459 Boehringer Ingelheim Investigational Site
      • Glasgow、英国
        • 1200.131.04460 Boehringer Ingelheim Investigational Site
      • Leicester、英国
        • 1200.131.04453 Boehringer Ingelheim Investigational Site
      • London、英国
        • 1200.131.04451 Boehringer Ingelheim Investigational Site
      • Manchester、英国
        • 1200.131.04452 Boehringer Ingelheim Investigational Site
      • Sheffield、英国
        • 1200.131.04454 Boehringer Ingelheim Investigational Site
      • Sutton、英国
        • 1200.131.04458 Boehringer Ingelheim Investigational Site
      • Whitchurch, Cardiff、英国
        • 1200.131.04457 Boehringer Ingelheim Investigational Site
  • 荷兰
      • Amsterdam、荷兰
        • 1200.131.03152 Boehringer Ingelheim Investigational Site
      • Leiden、荷兰
        • 1200.131.03153 Boehringer Ingelheim Investigational Site
      • Rotterdam、荷兰
        • 1200.131.03151 Boehringer Ingelheim Investigational Site
  • 葡萄牙
      • Almada、葡萄牙
        • 1200.131.35155 Boehringer Ingelheim Investigational Site
      • Coimbra、葡萄牙
        • 1200.131.35154 Boehringer Ingelheim Investigational Site
      • Lisboa、葡萄牙
        • 1200.131.35153 Boehringer Ingelheim Investigational Site
      • Porto、葡萄牙
        • 1200.131.35151 Boehringer Ingelheim Investigational Site
      • Évora、葡萄牙
        • 1200.131.35152 Boehringer Ingelheim Investigational Site
  • 西班牙
      • Barcelona、西班牙
        • 1200.131.03451 Boehringer Ingelheim Investigational Site
      • Barcelona、西班牙
        • 1200.131.03454 Boehringer Ingelheim Investigational Site
      • Girona、西班牙
        • 1200.131.03463 Boehringer Ingelheim Investigational Site
      • Hospitalet de Llobregat、西班牙
        • 1200.131.03452 Boehringer Ingelheim Investigational Site
      • Lugo、西班牙
        • 1200.131.03459 Boehringer Ingelheim Investigational Site
      • Madrid、西班牙
        • 1200.131.03457 Boehringer Ingelheim Investigational Site
      • Madrid、西班牙
        • 1200.131.03464 Boehringer Ingelheim Investigational Site
      • Madrid、西班牙
        • 1200.131.03465 Boehringer Ingelheim Investigational Site
      • Málaga、西班牙
        • 1200.131.03456 Boehringer Ingelheim Investigational Site
      • Málaga、西班牙
        • 1200.131.03462 Boehringer Ingelheim Investigational Site
      • Pamplona、西班牙
        • 1200.131.03455 Boehringer Ingelheim Investigational Site
      • Pozuelo De Alarcón, Madrid、西班牙
        • 1200.131.03460 Boehringer Ingelheim Investigational Site
      • Sevilla、西班牙
        • 1200.131.03466 Boehringer Ingelheim Investigational Site
      • Zaragoza、西班牙
        • 1200.131.03458 Boehringer Ingelheim Investigational Site
      • Ávila、西班牙
        • 1200.131.03461 Boehringer Ingelheim Investigational Site
  • 阿根廷
      • Ciudad Autonoma de Bs As、阿根廷
        • 1200.131.05451 Boehringer Ingelheim Investigational Site
      • Cordoba、阿根廷
        • 1200.131.05457 Boehringer Ingelheim Investigational Site
      • San Miguel de Tucuman、阿根廷
        • 1200.131.05458 Boehringer Ingelheim Investigational Site
      • Santa Fe、阿根廷
        • 1200.131.05452 Boehringer Ingelheim Investigational Site
      • Villa Dominico、阿根廷
        • 1200.131.05453 Boehringer Ingelheim Investigational 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 及以上 (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

Inclusion criteria:

  1. Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
  2. Unresected tumour prior to chemo-radiotherapy (CRT)
  3. Concomitant CRT completed prior to randomisation
  4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
  5. Eastern cooperative oncology group (ECOG) performance status 0 or 1

Exclusion criteria:

  1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
  2. Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil
  3. Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years
  4. Known pre-existing Interstitial Lung Disease (ILD)
  5. Pregnancy or breast feeding

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：阿法替尼 (BIBW 2992)
每天一次
药品：阿法替尼
每天一次
安慰剂比较：安慰剂
每天一次
药品：安慰剂
每天一次

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
Disease Free Survival (DFS)
大体时间：Up to 5 years
Disease Free Survival defined as the time from randomisation until documented tumour recurrence/ second primary tumour (SPT) or death from any cause, whichever occurred first.
Up to 5 years

次要结果测量

结果测量
措施说明
大体时间
Disease Free Survival (DFS) Rate at 2 Years
大体时间：Up to 2 years
Disease Free Survival (DFS) rate at 2 years. Probability of being disease free at 2 years in percentage is provided based on Kaplan-Meier method.
Up to 2 years
Percentage of Patient Deaths (Overall Survival (OS))
大体时间：Up to 5 years
Overall survival (OS), defined as the time from randomisation until death (regardless of cause). Due to the small event rate in both treatment arms caused by the early termination of the trial, the hazard estimate is not interpretable. Hence presented the total randomized and the percentage of patients died.
Up to 5 years
Patients With Improved Health Related Quality of Life (HRQOL)
大体时间：Up to 5 years
HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Improvement was defined as a score that improved from baseline by at least 10 points (on the 0-100 point scale) at any time during the study. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the study. Patients who had neither improved nor worsened were considered as stable. Percentages of patients with improvement in HRQoL are presented.
Up to 5 years
Time to Deterioration in Health Related Quality of Life (HRQOL)
大体时间：Up to 5 years
HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Time to deterioration was defined as the time from randomisation to the first 10-point worsening on the 0-100 point scale. Patients with no deterioration (including those with disease recurrence/SPT) were censored at the last available HRQoL assessment date. Patients with no post-baseline assessments were censored on the day of randomisation.
Up to 5 years
Health Related Quality of Life (HRQOL) Scores Over Time
大体时间：Baseline and 5 years
HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Scoring of the symptom scales/items followed the European Organisation for Research and Treatment of Cancer (EORTC) scoring manual and a linear transformation of the scores to a 0-100 point scale. Higher values are better.
Baseline and 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

Boehringer Ingelheim

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。

一般刊物

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)

2011年10月17日

初级完成 (实际的)

2016年9月12日

研究完成 (实际的)

2016年9月12日

研究注册日期

首次提交

2011年4月28日

首先提交符合 QC 标准的

2011年4月29日

首次发布 (估计)

2011年5月2日

研究记录更新

最后更新发布 (实际的)

2017年12月7日

上次提交的符合 QC 标准的更新

2017年11月3日

最后验证

2017年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1200.131
  • 2011-000392-14 (EudraCT编号：EudraCT)

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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