LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung
26 марта 2020 г. обновлено: Boehringer Ingelheim
LUX-Lung 7: A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung
This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
319
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
New South Wales
-
Camperdown, New South Wales, Австралия, 2050
- Chris OBrien Lifehouse
-
Kogarah, New South Wales, Австралия, 2217
- St George Hospital
-
-
Queensland
-
Chermside, Queensland, Австралия, 4032
- The Prince Charles Hospital
-
South Brisbane, Queensland, Австралия, 4101
- Haematology & Oncology Clinics of Australasia (HOCA)
-
-
Victoria
-
Box Hill, Victoria, Австралия, 3128
- Box Hill Hospital
-
Heidelberg, Victoria, Австралия, 3084
- Austin Health
-
-
Western Australia
-
Nedlands, Western Australia, Австралия, 6009
- Sir Charles Gairdner Hospital
-
-
-
-
-
Essen, Германия, 45122
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
-
Esslingen, Германия, 73730
- Klinikum Esslingen GmbH
-
Mainz, Германия, 55131
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
-
-
-
-
-
Hongkong, Гонконг
- Queen Mary Hospital
-
Shatin, Гонконг
- Prince of Wales Hospital
-
-
-
-
-
Dublin, Ирландия, 8
- St James's Hospital
-
Dublin 9, Ирландия, D09 Y5R3
- Beaumont Hospital
-
-
-
-
-
Madrid, Испания, 28041
- Hospital Universitario 12 De Octubre
-
Malaga, Испания, 29010
- Hospital Regional Universitario de Málaga
-
Oviedo, Испания, 33006
- Hospital Central de Asturias
-
Santander, Испания, 39008
- Hospital Universitario Marqués de Valdecilla
-
Sevilla, Испания, 41013
- Hospital Virgen del Rocío
-
-
-
-
Alberta
-
Edmonton, Alberta, Канада, T6G 1Z2
- Cross Cancer Institute (University of Alberta)
-
-
British Columbia
-
Surrey, British Columbia, Канада, V1V 1Z2
- British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer
-
Vancouver, British Columbia, Канада, V5Z 4E6
- BC Cancer Agency - Vancouver
-
-
Ontario
-
Oshawa, Ontario, Канада, L1G 2B9
- Lakeridge Health Oshawa
-
Ottawa, Ontario, Канада, K1H 8L6
- The Ottawa Hospital
-
-
Quebec
-
Montreal, Quebec, Канада, H3G 1A4
- Montreal General Hospital - McGill University Health Centre
-
-
-
-
-
Beijing, Китай, 100021
- Cancer Hospital of Chinese Academy of Medical Science
-
Beijing, Китай, 100036
- Beijing Cancer Hospital
-
Guangzhou, Китай, 510060
- Sun Yat-Sen University Cancer Center
-
Nan Ning, Китай, 530021
- The Affiliated Cancer Hospital, Guangxi Medical University
-
Shanghai, Китай, 200030
- Shanghai Chest Hospital
-
Shanghai, Китай, 200032
- Zhongshan Hospital Fudan University
-
Shenyang, Китай, 110001
- The First Hospital of Chinese Medical University
-
-
-
-
-
Cheongju, Корея, Республика, 361-771
- Chungbuk National University Hospital
-
Incheon, Корея, Республика, 405-760
- Gachon University Gil Medical Center
-
Seoul, Корея, Республика, 135-710
- Samsung Medical Center
-
Seoul, Корея, Республика, 138-736
- Asan Medical Center
-
Seoul, Корея, Республика, 110-744
- Seoul National University Hospital
-
Seoul, Корея, Республика, 120-752
- Severance Hospital
-
-
-
-
-
Oslo, Норвегия, N-0379
- Oslo Universitetssykehus HF, Radiumhospitalet
-
-
-
-
-
Singapore, Сингапур, 308433
- Johns Hopkins Singapore International Medical Center
-
Singapore, Сингапур, 169610
- National Cancer Centre
-
-
-
-
-
Aberdeen, Соединенное Королевство, AB25 2ZN
- Aberdeen Royal Infirmary
-
Birmingham, Соединенное Королевство, B18 7QH
- Birmingham City Hospital
-
Cardiff, Соединенное Королевство, CF14 2TL
- Velindre Cancer Centre
-
Edinburgh, Соединенное Королевство, EH4 2XU
- Western General Hospital
-
Guildford, Соединенное Королевство, GU2 7XX
- Royal Surrey County Hospital
-
-
-
-
-
Taichung, Тайвань, 407
- Taichung Veterans General Hospital
-
Tainan, Тайвань, 704
- NCKUH
-
Taipei, Тайвань, 100
- National Taiwan University Hospital
-
Taipei, Тайвань, 112
- Taipe Veterans General Hospital
-
Tao-Yuan, Тайвань, 333
- Chang Gung Memorial Hospital(Linkou)
-
-
-
-
-
Bayonne, Франция, 64100
- CTR Oncologie du Pays Basque, Onco, Bayonne
-
Caen, Франция, 14076
- CTR François Baclesse
-
Créteil, Франция, 94010
- HOP Intercommunal
-
La Tronche, Франция, 38700
- HOP Michallon
-
Limoges Cedex, Франция, 87042
- HOP Dupuytren 1
-
Lyon, Франция, 69373
- CTR Leon Berard
-
Saint Herblain, Франция, 44805
- CTR René Gauducheau
-
St-Pierre - La Réunion, Франция, 97448
- HOP Sud-Réunion, Pneumo, Saint Pierre
-
-
-
-
-
Göteborg, Швеция, 413 45
- Sahlgrenska US, Göteborg
-
Linköping, Швеция, 581 85
- Universitetssjukhuset, Linköping
-
Lund, Швеция, 221 85
- Skånes universitetssjukhus, Lund
-
Stockholm, Швеция, 171 76
- Karolinska Univ. sjukhuset
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 90 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion criteria:
- Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
- Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
- At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Age >= 18 years.
- Adequate organ function as defined by the following criteria:
Serum aspartate transaminase(AST) and serum alanine transaminase(ALT) =< 3 x upper limit of normal (ULN), or AST and ALT =<5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin =<1.5 x ULN Absolute neutrophil count (ANC) >=1.5 x 109/L Creatinine clearance > 45ml / min Platelets >= 75 x 109/L
Exclusion criteria:
- Prior systemic chemotherapy for stage IIIB or IV non-small cell lung cancer. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least 12 months has elapsed prior to disease progression.
- Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.
- Major surgery within 4 weeks of study randomisation.
- Active brain metastases
- Meningeal carcinomatosis.
- Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured in the opinion of investigator.
- Known pre-existing interstitial lung disease.
- Clinically relevant cardiovascular abnormalities as judged by the investigator.
- Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.
- Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
- Pregnancy or breast-feeding.
- Active hepatitis and/or known HIV carrier
- Any prohibited concomitant medications for therapy with afatinib or gefitinib
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: afatinib
afatinib once daily.
|
afatinib once daily
Другие имена:
|
|
Активный компаратор: gefitinib
gefitinib once daily
|
Gefitinib once daily
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Progression-free Survival
Временное ограничение: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
|
Progression-free survival (PFS) defined as the time from date of randomisation to date of disease progression, or date of death if a patient died earlier.
Participants with no event (Disease progression (PD) or death) were censored.
PD was primarily evaluated for the primary analysis by an independent central imaging review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
Per RECIST version 1.1.
for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): PD, At least a 20% increase in the sum of the longest diameter (SoD) of target lesions taking as reference the smallest SoD of target lesions recorded since the treatment started, together with an absolute increase in the SoD of target lesions of at least 5 millimetre (mm) or the appearance of one or more new lesions.
For the final analysis (analysis cut-off date 12 April 2019) status and date of PD were determined by investigator assessment.
|
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
|
|
Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
Временное ограничение: From first drug administration until last drug administration, up to 1482 days
|
Time to Treatment Failure (TTF) which was the time from the date of randomisation to the date of i.e. permanent treatment discontinuation for any reason.
|
From first drug administration until last drug administration, up to 1482 days
|
|
Overall Survival
Временное ограничение: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days.
|
Overall survival (OS) which was defined as the time from the date of randomisation to the date of death.
Participants for whom there is no evidence of death at the time of the analysis will be censored at the date that they were last known to be alive.
|
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Objective Response Rate
Временное ограничение: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
|
Objective response rate (ORR) which was defined as the number of participants with best overall response of complete response (CR) or partial response (PR) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
divided by the total number of participants who received treatment.
Per RECIST version 1.1.
for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions from baseline.
For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment.
|
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
|
|
Time to Objective Response
Временное ограничение: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
|
Number of participants with objective response (best overall response of complete response or partial response) to study treatment over time, cumulative number of participants is displayed.
Time to objective response was defined as the time from randomisation to the first recorded objective response.
For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment.
|
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
|
|
Duration of Objective Response
Временное ограничение: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
|
Duration of objective response defined as the time of first objective response (best overall response of complete response or partial response) to the time of progression or death, whichever occurred first (or date of censoring for progression free survival).
For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment.
|
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.
|
|
Disease Control
Временное ограничение: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
|
Percentage of participants with disease control which was defined as the number of participants with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
divided by the total number of participants who received treatment.
Per RECIST version 1.1.
for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Responses of SD were only considered if they occur ≥42 days from date of randomisation.
For the final analysis (analysis cut-off date 12 April 2019) disease control was determined by investigator assessment.
|
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
|
|
Duration of Disease Control
Временное ограничение: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
|
Duration of disease control defined as the time from randomisation to the time of progression or death, whichever occurred first (or date of censoring for progression free survival).
For the final analysis (analysis cut-off date 12 April 2019) the status and date of disease progression were determined by investigator assessment.
|
From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.
|
|
Tumour Shrinkage (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
Временное ограничение: From first drug administration until last drug administration, up to 1482 days
|
Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation.
A positive value shows a decrease in tumour size.
|
From first drug administration until last drug administration, up to 1482 days
|
|
Health-related Quality of Life (Primary Analysis Cut-off Date, 21 August 2015)
Временное ограничение: Every 8 weeks, up to 56 weeks
|
Health-related quality of life (HRQoL) measured using European Quality of life - 5 Dimensions (EQ-5D) score for United Kingdom (UK) and Belgium and European European Quality Visual Analogue Scale (EQ-VAS). EQ-5D utility scores range from 0 (worst health) to 1 (full health). EQ-VAS scores range from 0 (worst imaginable health state) to 100 (best imaginable health state). Results display the mean score up to 56 weeks. |
Every 8 weeks, up to 56 weeks
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Marten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17.
- Paz-Ares L, Tan EH, O'Byrne K, Zhang L, Hirsh V, Boyer M, Yang JC, Mok T, Lee KH, Lu S, Shi Y, Lee DH, Laskin J, Kim DW, Laurie SA, Kolbeck K, Fan J, Dodd N, Marten A, Park K. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Ann Oncol. 2017 Feb 1;28(2):270-277. doi: 10.1093/annonc/mdw611.
- Park K, Tan EH, O'Byrne K, Zhang L, Boyer M, Mok T, Hirsh V, Yang JC, Lee KH, Lu S, Shi Y, Kim SW, Laskin J, Kim DW, Arvis CD, Kolbeck K, Laurie SA, Tsai CM, Shahidi M, Kim M, Massey D, Zazulina V, Paz-Ares L. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol. 2016 May;17(5):577-89. doi: 10.1016/S1470-2045(16)30033-X. Epub 2016 Apr 12.
Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
13 декабря 2011 г.
Первичное завершение (Действительный)
8 апреля 2016 г.
Завершение исследования (Действительный)
12 апреля 2019 г.
Даты регистрации исследования
Первый отправленный
4 ноября 2011 г.
Впервые представлено, что соответствует критериям контроля качества
4 ноября 2011 г.
Первый опубликованный (Оценивать)
8 ноября 2011 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
7 апреля 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
26 марта 2020 г.
Последняя проверка
1 марта 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания дыхательных путей
- Новообразования по гистологическому типу
- Новообразования
- Легочные заболевания
- Новообразования по локализации
- Карцинома
- Новообразования железистые и эпителиальные
- Новообразования дыхательных путей
- Грудные новообразования
- Новообразования легких
- Аденокарцинома
- Аденокарцинома легкого
- Молекулярные механизмы фармакологического действия
- Ингибиторы ферментов
- Противоопухолевые агенты
- Ингибиторы протеинкиназы
- Гефитиниб
- Афатиниб
Другие идентификационные номера исследования
- 1200.123
- 2011-001814-33 (Номер EudraCT)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .