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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 de março de 2020 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

319

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 90 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: afatinib
afatinib once daily.
Medicamento: Afatinib
afatinib once daily
Outros nomes:
  • Giotrif® / Gilotrif®
Comparador Ativo: gefitinib
gefitinib once daily
Medicamento: gefitinib
Gefitinib once daily

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-free Survival
Prazo: 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)
Prazo: 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
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Objective Response Rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Boehringer Ingelheim

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

13 de dezembro de 2011

Conclusão Primária (Real)

8 de abril de 2016

Conclusão do estudo (Real)

12 de abril de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

4 de novembro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de novembro de 2011

Primeira postagem (Estimativa)

8 de novembro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Real)

7 de abril de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de março de 2020

Última verificação

1 de março de 2020

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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