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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. března 2020 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

319

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 90 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: afatinib
afatinib once daily.
Lék: Afatinib
afatinib once daily
Ostatní jména:
  • Giotrif® / Gilotrif®
Aktivní komparátor: gefitinib
gefitinib once daily
Lék: gefitinib
Gefitinib once daily

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression-free Survival
Časové okno: 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)
Časové okno: 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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Objective Response Rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Boehringer Ingelheim

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

13. prosince 2011

Primární dokončení (Aktuální)

8. dubna 2016

Dokončení studie (Aktuální)

12. dubna 2019

Termíny zápisu do studia

První předloženo

4. listopadu 2011

První předloženo, které splnilo kritéria kontroly kvality

4. listopadu 2011

První zveřejněno (Odhad)

8. listopadu 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. dubna 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. března 2020

Naposledy ověřeno

1. března 2020

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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