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. március 26. frissítette: 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.
A tanulmány áttekintése
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
319
Fázis
- 2. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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New South Wales
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Camperdown, New South Wales, Ausztrália, 2050
- Chris OBrien Lifehouse
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Kogarah, New South Wales, Ausztrália, 2217
- St George Hospital
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Queensland
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Chermside, Queensland, Ausztrália, 4032
- The Prince Charles Hospital
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South Brisbane, Queensland, Ausztrália, 4101
- Haematology & Oncology Clinics of Australasia (HOCA)
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Victoria
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Box Hill, Victoria, Ausztrália, 3128
- Box Hill Hospital
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Heidelberg, Victoria, Ausztrália, 3084
- Austin Health
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Western Australia
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Nedlands, Western Australia, Ausztrália, 6009
- Sir Charles Gairdner Hospital
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Aberdeen, Egyesült Királyság, AB25 2ZN
- Aberdeen Royal Infirmary
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Birmingham, Egyesült Királyság, B18 7QH
- Birmingham City Hospital
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Cardiff, Egyesült Királyság, CF14 2TL
- Velindre Cancer Centre
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Edinburgh, Egyesült Királyság, EH4 2XU
- Western General Hospital
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Guildford, Egyesült Királyság, GU2 7XX
- Royal Surrey County Hospital
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Bayonne, Franciaország, 64100
- CTR Oncologie du Pays Basque, Onco, Bayonne
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Caen, Franciaország, 14076
- CTR François Baclesse
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Créteil, Franciaország, 94010
- HOP Intercommunal
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La Tronche, Franciaország, 38700
- HOP Michallon
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Limoges Cedex, Franciaország, 87042
- HOP Dupuytren 1
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Lyon, Franciaország, 69373
- CTR Leon Berard
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Saint Herblain, Franciaország, 44805
- CTR René Gauducheau
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St-Pierre - La Réunion, Franciaország, 97448
- HOP Sud-Réunion, Pneumo, Saint Pierre
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Hongkong, Hong Kong
- Queen Mary Hospital
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Shatin, Hong Kong
- Prince of Wales Hospital
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Alberta
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Edmonton, Alberta, Kanada, T6G 1Z2
- Cross Cancer Institute (University of Alberta)
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British Columbia
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Surrey, British Columbia, Kanada, V1V 1Z2
- British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer
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Vancouver, British Columbia, Kanada, V5Z 4E6
- BC Cancer Agency - Vancouver
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Ontario
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Oshawa, Ontario, Kanada, L1G 2B9
- Lakeridge Health Oshawa
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Ottawa, Ontario, Kanada, K1H 8L6
- The Ottawa Hospital
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Quebec
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Montreal, Quebec, Kanada, H3G 1A4
- Montreal General Hospital - McGill University Health Centre
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Cheongju, Koreai Köztársaság, 361-771
- Chungbuk National University Hospital
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Incheon, Koreai Köztársaság, 405-760
- Gachon University Gil Medical Center
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Seoul, Koreai Köztársaság, 135-710
- Samsung Medical Center
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Seoul, Koreai Köztársaság, 138-736
- Asan Medical Center
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Seoul, Koreai Köztársaság, 110-744
- Seoul National University Hospital
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Seoul, Koreai Köztársaság, 120-752
- Severance Hospital
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Beijing, Kína, 100021
- Cancer Hospital of Chinese Academy of Medical Science
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Beijing, Kína, 100036
- Beijing Cancer Hospital
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Guangzhou, Kína, 510060
- Sun Yat-sen University Cancer Center
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Nan Ning, Kína, 530021
- The Affiliated Cancer Hospital, Guangxi Medical University
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Shanghai, Kína, 200030
- Shanghai Chest Hospital
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Shanghai, Kína, 200032
- Zhongshan Hospital Fudan University
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Shenyang, Kína, 110001
- The First Hospital of Chinese Medical University
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Oslo, Norvégia, N-0379
- Oslo Universitetssykehus HF, Radiumhospitalet
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Essen, Németország, 45122
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
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Esslingen, Németország, 73730
- Klinikum Esslingen GmbH
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Mainz, Németország, 55131
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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Madrid, Spanyolország, 28041
- Hospital Universitario 12 de Octubre
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Malaga, Spanyolország, 29010
- Hospital Regional Universitario de Málaga
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Oviedo, Spanyolország, 33006
- Hospital Central de Asturias
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Santander, Spanyolország, 39008
- Hospital Universitario Marqués de Valdecilla
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Sevilla, Spanyolország, 41013
- Hospital Virgen Del Rocio
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Göteborg, Svédország, 413 45
- Sahlgrenska US, Göteborg
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Linköping, Svédország, 581 85
- Universitetssjukhuset, Linköping
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Lund, Svédország, 221 85
- Skånes Universitetssjukhus, Lund
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Stockholm, Svédország, 171 76
- Karolinska Univ. sjukhuset
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Singapore, Szingapúr, 308433
- Johns Hopkins Singapore International Medical Center
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Singapore, Szingapúr, 169610
- National Cancer Centre
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Taichung, Tajvan, 407
- Taichung Veterans General Hospital
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Tainan, Tajvan, 704
- NCKUH
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Taipei, Tajvan, 100
- National Taiwan University Hospital
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Taipei, Tajvan, 112
- Taipe Veterans General Hospital
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Tao-Yuan, Tajvan, 333
- Chang Gung Memorial Hospital(Linkou)
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Dublin, Írország, 8
- St James's Hospital
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Dublin 9, Írország, D09 Y5R3
- Beaumont Hospital
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: afatinib
afatinib once daily.
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afatinib once daily
Más nevek:
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Aktív összehasonlító: gefitinib
gefitinib once daily
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Gefitinib once daily
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Progression-free Survival
Időkeret: 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)
Időkeret: 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
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Objective Response Rate
Időkeret: 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.
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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
Időkeret: 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.
|
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
Időkeret: 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.
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Disease Control
Időkeret: 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
Időkeret: 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)
Időkeret: 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.
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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)
Időkeret: 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
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- 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.
Hasznos linkek
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2011. december 13.
Elsődleges befejezés (Tényleges)
2016. április 8.
A tanulmány befejezése (Tényleges)
2019. április 12.
Tanulmányi regisztráció dátumai
Először benyújtva
2011. november 4.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2011. november 4.
Első közzététel (Becslés)
2011. november 8.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2020. április 7.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2020. március 26.
Utolsó ellenőrzés
2020. március 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Légúti betegségek
- Neoplazmák szövettani típus szerint
- Neoplazmák
- Tüdőbetegségek
- Neoplazmák webhelyenként
- Karcinóma
- Neoplazmák, mirigyes és epiteliális
- Légúti neoplazmák
- Mellkasi neoplazmák
- Tüdő neoplazmák
- Adenokarcinóma
- A tüdő adenokarcinóma
- A farmakológiai hatás molekuláris mechanizmusai
- Enzim gátlók
- Antineoplasztikus szerek
- Protein kináz inhibitorok
- Gefitinib
- Afatinib
Egyéb vizsgálati azonosító számok
- 1200.123
- 2011-001814-33 (EudraCT szám)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .