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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 marca 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

319

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris OBrien Lifehouse
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Haematology & Oncology Clinics of Australasia (HOCA)
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Chiny
      • Beijing, Chiny, 100021
        • Cancer Hospital of Chinese Academy of Medical Science
      • Beijing, Chiny, 100036
        • Beijing Cancer Hospital
      • Guangzhou, Chiny, 510060
        • Sun Yat-sen University Cancer Center
      • Nan Ning, Chiny, 530021
        • The Affiliated Cancer Hospital, Guangxi Medical University
      • Shanghai, Chiny, 200030
        • Shanghai Chest Hospital
      • Shanghai, Chiny, 200032
        • Zhongshan Hospital Fudan University
      • Shenyang, Chiny, 110001
        • The First Hospital of Chinese Medical University
  • Francja
      • Bayonne, Francja, 64100
        • CTR Oncologie du Pays Basque, Onco, Bayonne
      • Caen, Francja, 14076
        • CTR François Baclesse
      • Créteil, Francja, 94010
        • HOP Intercommunal
      • La Tronche, Francja, 38700
        • HOP Michallon
      • Limoges Cedex, Francja, 87042
        • HOP Dupuytren 1
      • Lyon, Francja, 69373
        • CTR Leon Berard
      • Saint Herblain, Francja, 44805
        • CTR René Gauducheau
      • St-Pierre - La Réunion, Francja, 97448
        • HOP Sud-Réunion, Pneumo, Saint Pierre
  • Hiszpania
      • Madrid, Hiszpania, 28041
        • Hospital Universitario 12 de Octubre
      • Malaga, Hiszpania, 29010
        • Hospital Regional Universitario de Malaga
      • Oviedo, Hiszpania, 33006
        • Hospital Central de Asturias
      • Santander, Hiszpania, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Sevilla, Hiszpania, 41013
        • Hospital Virgen del Rocío
  • Hongkong
      • Hongkong, Hongkong
        • Queen Mary Hospital
      • Shatin, Hongkong
        • Prince Of Wales Hospital
  • Irlandia
      • Dublin, Irlandia, 8
        • St James's Hospital
      • Dublin 9, Irlandia, D09 Y5R3
        • Beaumont Hospital
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 1Z2
        • Cross Cancer Institute (University of Alberta)
    • British Columbia
      • Surrey, British Columbia, Kanada, V1V 1Z2
        • British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer
      • Vancouver, British Columbia, Kanada, V5Z 4E6
        • BC Cancer Agency - Vancouver
    • Ontario
      • Oshawa, Ontario, Kanada, L1G 2B9
        • Lakeridge Health Oshawa
      • Ottawa, Ontario, Kanada, K1H 8L6
        • The Ottawa Hospital
    • Quebec
      • Montreal, Quebec, Kanada, H3G 1A4
        • Montreal General Hospital - McGill University Health Centre
  • Niemcy
      • Essen, Niemcy, 45122
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
      • Esslingen, Niemcy, 73730
        • Klinikum Esslingen GmbH
      • Mainz, Niemcy, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Norwegia
      • Oslo, Norwegia, N-0379
        • Oslo Universitetssykehus HF, Radiumhospitalet
  • Republika Korei
      • Cheongju, Republika Korei, 361-771
        • Chungbuk National University Hospital
      • Incheon, Republika Korei, 405-760
        • Gachon University Gil Medical Center
      • Seoul, Republika Korei, 135-710
        • Samsung Medical Center
      • Seoul, Republika Korei, 138-736
        • Asan Medical Center
      • Seoul, Republika Korei, 110-744
        • Seoul National University Hospital
      • Seoul, Republika Korei, 120-752
        • Severance Hospital
  • Singapur
      • Singapore, Singapur, 308433
        • Johns Hopkins Singapore International Medical Center
      • Singapore, Singapur, 169610
        • National Cancer Centre
  • Szwecja
      • Göteborg, Szwecja, 413 45
        • Sahlgrenska US, Göteborg
      • Linköping, Szwecja, 581 85
        • Universitetssjukhuset, Linköping
      • Lund, Szwecja, 221 85
        • Skånes universitetssjukhus, Lund
      • Stockholm, Szwecja, 171 76
        • Karolinska Univ. sjukhuset
  • Tajwan
      • Taichung, Tajwan, 407
        • Taichung Veterans General Hospital
      • Tainan, Tajwan, 704
        • NCKUH
      • Taipei, Tajwan, 100
        • National Taiwan University Hospital
      • Taipei, Tajwan, 112
        • Taipe Veterans General Hospital
      • Tao-Yuan, Tajwan, 333
        • Chang Gung Memorial Hospital(Linkou)
  • Zjednoczone Królestwo
      • Aberdeen, Zjednoczone Królestwo, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Birmingham, Zjednoczone Królestwo, B18 7QH
        • Birmingham City Hospital
      • Cardiff, Zjednoczone Królestwo, CF14 2TL
        • Velindre Cancer Centre
      • Edinburgh, Zjednoczone Królestwo, EH4 2XU
        • Western General Hospital
      • Guildford, Zjednoczone Królestwo, GU2 7XX
        • Royal Surrey County Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 90 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion criteria:

  1. Pathologically confirmed diagnosis of Stage IIIB / IV adenocarcinoma of the lung.
  2. Documented activating epidermal growth factor receptor mutation (Del19 and/or L858R) with tumour tissues.
  3. At least one measurable lesion according to response evaluation criteria in solid tumours version 1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  5. Age >= 18 years.
  6. 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:

  1. 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.
  2. Prior treatment with epidermal growth factor receptor targeting small molecules or antibodies.
  3. Major surgery within 4 weeks of study randomisation.
  4. Active brain metastases
  5. Meningeal carcinomatosis.
  6. 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.
  7. Known pre-existing interstitial lung disease.
  8. Clinically relevant cardiovascular abnormalities as judged by the investigator.
  9. Cardiac left ventricular function with resting ejection fraction of less than institutional lower limit of normal.
  10. 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.
  11. Pregnancy or breast-feeding.
  12. Active hepatitis and/or known HIV carrier
  13. Any prohibited concomitant medications for therapy with afatinib or gefitinib

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: afatinib
afatinib once daily.
Lek: Afatinib
afatinib once daily
Inne nazwy:
  • Giotrif® / Gilotrif®
Aktywny komparator: gefitinib
gefitinib once daily
Lek: gefitinib
Gefitinib once daily

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Progression-free Survival
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Objective Response Rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Boehringer Ingelheim

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 grudnia 2011

Zakończenie podstawowe (Rzeczywisty)

8 kwietnia 2016

Ukończenie studiów (Rzeczywisty)

12 kwietnia 2019

Daty rejestracji na studia

Pierwszy przesłany

4 listopada 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 listopada 2011

Pierwszy wysłany (Oszacować)

8 listopada 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 kwietnia 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 marca 2020

Ostatnia weryfikacja

1 marca 2020

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 1200.123
  • 2011-001814-33 (Numer EudraCT)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Nowotwory płuc

Badania kliniczne na Afatinib

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