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
2020년 3월 26일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
319
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Oslo, 노르웨이, N-0379
- Oslo Universitetssykehus HF, Radiumhospitalet
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Taichung, 대만, 407
- Taichung Veterans General Hospital
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Tainan, 대만, 704
- NCKUH
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Taipei, 대만, 100
- National Taiwan University Hospital
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Taipei, 대만, 112
- Taipe Veterans General Hospital
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Tao-Yuan, 대만, 333
- Chang Gung Memorial Hospital(Linkou)
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Cheongju, 대한민국, 361-771
- Chungbuk National University Hospital
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Incheon, 대한민국, 405-760
- Gachon University Gil Medical Center
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Seoul, 대한민국, 135-710
- Samsung Medical Center
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Seoul, 대한민국, 138-736
- Asan Medical Center
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Seoul, 대한민국, 110-744
- Seoul National University Hospital
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Seoul, 대한민국, 120-752
- Severance Hospital
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Essen, 독일, 45122
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
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Esslingen, 독일, 73730
- Klinikum Esslingen GmbH
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Mainz, 독일, 55131
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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Göteborg, 스웨덴, 413 45
- Sahlgrenska US, Göteborg
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Linköping, 스웨덴, 581 85
- Universitetssjukhuset, Linköping
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Lund, 스웨덴, 221 85
- Skånes universitetssjukhus, Lund
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Stockholm, 스웨덴, 171 76
- Karolinska Univ. sjukhuset
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Madrid, 스페인, 28041
- Hospital Universitario 12 de octubre
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Malaga, 스페인, 29010
- Hospital Regional Universitario de Málaga
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Oviedo, 스페인, 33006
- Hospital Central de Asturias
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Santander, 스페인, 39008
- Hospital Universitario Marques de Valdecilla
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Sevilla, 스페인, 41013
- Hospital Virgen del Rocío
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Singapore, 싱가포르, 308433
- Johns Hopkins Singapore International Medical Center
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Singapore, 싱가포르, 169610
- National Cancer Centre
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Dublin, 아일랜드, 8
- St James's Hospital
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Dublin 9, 아일랜드, D09 Y5R3
- Beaumont Hospital
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Aberdeen, 영국, AB25 2ZN
- Aberdeen Royal Infirmary
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Birmingham, 영국, B18 7QH
- Birmingham City Hospital
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Cardiff, 영국, CF14 2TL
- Velindre Cancer Centre
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Edinburgh, 영국, EH4 2XU
- Western General Hospital
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Guildford, 영국, GU2 7XX
- Royal Surrey County Hospital
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Beijing, 중국, 100021
- Cancer Hospital of Chinese Academy of Medical Science
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Beijing, 중국, 100036
- Beijing Cancer Hospital
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Guangzhou, 중국, 510060
- Sun Yat-Sen University Cancer Center
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Nan Ning, 중국, 530021
- The Affiliated Cancer Hospital, Guangxi Medical University
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Shanghai, 중국, 200030
- Shanghai Chest Hospital
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Shanghai, 중국, 200032
- Zhongshan Hospital Fudan University
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Shenyang, 중국, 110001
- The First Hospital of Chinese Medical University
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Alberta
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Edmonton, Alberta, 캐나다, T6G 1Z2
- Cross Cancer Institute (University of Alberta)
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British Columbia
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Surrey, British Columbia, 캐나다, V1V 1Z2
- British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer
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Vancouver, British Columbia, 캐나다, V5Z 4E6
- BC Cancer Agency - Vancouver
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Ontario
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Oshawa, Ontario, 캐나다, L1G 2B9
- Lakeridge Health Oshawa
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Ottawa, Ontario, 캐나다, K1H 8L6
- The Ottawa Hospital
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Quebec
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Montreal, Quebec, 캐나다, H3G 1A4
- Montreal General Hospital - McGill University Health Centre
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Bayonne, 프랑스, 64100
- CTR Oncologie du Pays Basque, Onco, Bayonne
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Caen, 프랑스, 14076
- CTR François Baclesse
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Créteil, 프랑스, 94010
- HOP Intercommunal
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La Tronche, 프랑스, 38700
- HOP Michallon
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Limoges Cedex, 프랑스, 87042
- HOP Dupuytren 1
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Lyon, 프랑스, 69373
- CTR Leon Berard
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Saint Herblain, 프랑스, 44805
- CTR René Gauducheau
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St-Pierre - La Réunion, 프랑스, 97448
- HOP Sud-Réunion, Pneumo, Saint Pierre
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New South Wales
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Camperdown, New South Wales, 호주, 2050
- Chris Obrien Lifehouse
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Kogarah, New South Wales, 호주, 2217
- St George Hospital
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Queensland
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Chermside, Queensland, 호주, 4032
- The Prince Charles Hospital
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South Brisbane, Queensland, 호주, 4101
- Haematology & Oncology Clinics of Australasia (HOCA)
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Victoria
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Box Hill, Victoria, 호주, 3128
- Box Hill Hospital
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Heidelberg, Victoria, 호주, 3084
- Austin Health
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Western Australia
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Nedlands, Western Australia, 호주, 6009
- Sir Charles Gairdner Hospital
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Hongkong, 홍콩
- Queen Mary Hospital
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Shatin, 홍콩
- Prince of Wales Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: afatinib
afatinib once daily.
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afatinib once daily
다른 이름들:
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활성 비교기: gefitinib
gefitinib once daily
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Gefitinib once daily
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-free Survival
기간: 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.
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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)
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Response Rate
기간: 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
기간: 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
기간: 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
기간: 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.
|
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
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2011년 12월 13일
기본 완료 (실제)
2016년 4월 8일
연구 완료 (실제)
2019년 4월 12일
연구 등록 날짜
최초 제출
2011년 11월 4일
QC 기준을 충족하는 최초 제출
2011년 11월 4일
처음 게시됨 (추정)
2011년 11월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 4월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 3월 26일
마지막으로 확인됨
2020년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1200.123
- 2011-001814-33 (EudraCT 번호)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
폐 신생물에 대한 임상 시험
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Novartis Pharmaceuticals완전한신경내분비종양 | GI 오리진의 고급 NET | 고급 NET of Lung Origin미국, 콜롬비아, 이탈리아, 대만, 영국, 벨기에, 체코, 독일, 일본, 사우디 아라비아, 캐나다, 네덜란드, 스페인, 대한민국, 레바논, 오스트리아, 중국, 그리스, 남아프리카, 태국, 헝가리, 칠면조, 폴란드, 슬로바키아, 러시아 연방
Afatinib에 대한 임상 시험
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Samsung Medical CenterAstraZeneca알려지지 않은