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
2020年3月26日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
319
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Dublin、アイルランド、8
- St James's Hospital
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Dublin 9、アイルランド、D09 Y5R3
- Beaumont Hospital
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Aberdeen、イギリス、AB25 2ZN
- Aberdeen Royal Infirmary
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Birmingham、イギリス、B18 7QH
- Birmingham City Hospital
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Cardiff、イギリス、CF14 2TL
- Velindre Cancer Centre
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Edinburgh、イギリス、EH4 2XU
- Western General Hospital
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Guildford、イギリス、GU2 7XX
- Royal Surrey County Hospital
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New South Wales
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Camperdown、New South Wales、オーストラリア、2050
- Chris Obrien Lifehouse
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Kogarah、New South Wales、オーストラリア、2217
- St George Hospital
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Queensland
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Chermside、Queensland、オーストラリア、4032
- The Prince Charles Hospital
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South Brisbane、Queensland、オーストラリア、4101
- Haematology & Oncology Clinics of Australasia (HOCA)
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Victoria
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Box Hill、Victoria、オーストラリア、3128
- Box Hill Hospital
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Heidelberg、Victoria、オーストラリア、3084
- Austin Health
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Western Australia
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Nedlands、Western Australia、オーストラリア、6009
- Sir Charles Gairdner Hospital
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Alberta
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Edmonton、Alberta、カナダ、T6G 1Z2
- Cross Cancer Institute (University of Alberta)
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British Columbia
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Surrey、British Columbia、カナダ、V1V 1Z2
- British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer
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Vancouver、British Columbia、カナダ、V5Z 4E6
- BC Cancer Agency - Vancouver
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Ontario
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Oshawa、Ontario、カナダ、L1G 2B9
- Lakeridge Health Oshawa
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Ottawa、Ontario、カナダ、K1H 8L6
- The Ottawa Hospital
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Quebec
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Montreal、Quebec、カナダ、H3G 1A4
- Montreal General Hospital - McGill University Health Centre
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Singapore、シンガポール、308433
- Johns Hopkins Singapore International Medical Center
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Singapore、シンガポール、169610
- National Cancer Centre
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Göteborg、スウェーデン、413 45
- Sahlgrenska US, Göteborg
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Linköping、スウェーデン、581 85
- Universitetssjukhuset, Linköping
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Lund、スウェーデン、221 85
- Skånes universitetssjukhus, Lund
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Stockholm、スウェーデン、171 76
- Karolinska Univ. sjukhuset
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Madrid、スペイン、28041
- Hospital Universitario 12 de Octubre
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Malaga、スペイン、29010
- Hospital Regional Universitario de Málaga
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Oviedo、スペイン、33006
- Hospital Central de Asturias
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Santander、スペイン、39008
- Hospital Universitario Marques de Valdecilla
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Sevilla、スペイン、41013
- Hospital Virgen del Rocío
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Essen、ドイツ、45122
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
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Esslingen、ドイツ、73730
- Klinikum Esslingen GmbH
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Mainz、ドイツ、55131
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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Oslo、ノルウェー、N-0379
- Oslo Universitetssykehus HF, Radiumhospitalet
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Bayonne、フランス、64100
- CTR Oncologie du Pays Basque, Onco, Bayonne
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Caen、フランス、14076
- CTR François Baclesse
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Créteil、フランス、94010
- HOP Intercommunal
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La Tronche、フランス、38700
- HOP Michallon
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Limoges Cedex、フランス、87042
- HOP Dupuytren 1
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Lyon、フランス、69373
- CTR Leon Berard
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Saint Herblain、フランス、44805
- CTR René Gauducheau
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St-Pierre - La Réunion、フランス、97448
- HOP Sud-Réunion, Pneumo, Saint Pierre
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Beijing、中国、100021
- Cancer Hospital of Chinese Academy of Medical Science
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Beijing、中国、100036
- Beijing Cancer Hospital
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Guangzhou、中国、510060
- Sun yat-sen University Cancer Center
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Nan Ning、中国、530021
- The Affiliated Cancer Hospital, Guangxi Medical University
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Shanghai、中国、200030
- Shanghai Chest Hospital
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Shanghai、中国、200032
- Zhongshan Hospital Fudan University
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Shenyang、中国、110001
- The First Hospital of Chinese Medical University
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Taichung、台湾、407
- Taichung Veterans General Hospital
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Tainan、台湾、704
- NCKUH
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Taipei、台湾、100
- National Taiwan University Hospital
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Taipei、台湾、112
- Taipe Veterans General Hospital
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Tao-Yuan、台湾、333
- Chang Gung Memorial Hospital(Linkou)
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Cheongju、大韓民国、361-771
- Chungbuk National University Hospital
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Incheon、大韓民国、405-760
- Gachon University Gil Medical Center
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Seoul、大韓民国、135-710
- Samsung Medical Center
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Seoul、大韓民国、138-736
- Asan Medical Center
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Seoul、大韓民国、110-744
- Seoul National University Hospital
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Seoul、大韓民国、120-752
- Severance Hospital
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Hongkong、香港
- Queen Mary Hospital
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Shatin、香港
- Prince of Wales Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～90年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：afatinib
afatinib once daily.
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afatinib once daily
他の名前：
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アクティブコンパレータ：gefitinib
gefitinib once daily
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Gefitinib once daily
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Progression-free Survival
時間枠：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.
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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.
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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.
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Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
時間枠：From first drug administration until last drug administration, up to 1482 days
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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.
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From first drug administration until last drug administration, up to 1482 days
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Overall Survival
時間枠：From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days.
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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.
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From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Objective Response Rate
時間枠：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.
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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.
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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.
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Time to Objective Response
時間枠：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.
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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.
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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.
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Duration of Objective Response
時間枠：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.
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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.
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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.
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Disease Control
時間枠：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.
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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.
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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.
|
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Duration of Disease Control
時間枠：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.
|
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Tumour Shrinkage (Main Overall Survival Analysis Cut-off Date, 08 April 2016)
時間枠：From first drug administration until last drug administration, up to 1482 days
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Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation.
A positive value shows a decrease in tumour size.
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From first drug administration until last drug administration, up to 1482 days
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Health-related Quality of Life (Primary Analysis Cut-off Date, 21 August 2015)
時間枠：Every 8 weeks, up to 56 weeks
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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
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2011年12月13日
一次修了 (実際)
2016年4月8日
研究の完了 (実際)
2019年4月12日
試験登録日
最初に提出
2011年11月4日
QC基準を満たした最初の提出物
2011年11月4日
最初の投稿 (見積もり)
2011年11月8日
学習記録の更新
投稿された最後の更新 (実際)
2020年4月7日
QC基準を満たした最後の更新が送信されました
2020年3月26日
最終確認日
2020年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
肺新生物の臨床試験
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Taichung Veterans General Hospital完了心毒性 | 非小細胞肺癌（MeSH用語：Carcinoma, Non-Small-Cell Lung） | 薬物関連の副作用および有害反応（MeSH用語） | EGFRチロシンキナーゼ阻害剤台湾
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Fondazione del Piemonte per l'Oncologia募集乳がん | 卵巣がん | 結腸直腸がん | 黒色腫 (皮膚がん) | 非小細胞肺癌（MeSH用語：Carcinoma, Non-Small-Cell Lung）イタリア