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A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations

5 de fevereiro de 2015 atualizado por: Hoffmann-La Roche

A Multicenter, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva®) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumors

This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours. Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m^2 iv on Day 1.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

217

Estágio

  • Fase 3

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

  • China
      • Beijing, China, 101149
      • Beijing, China, 100071
      • Changchun, China, 130012
      • ChongQing, China, 400042
      • Chongqing, China, 400038
      • Fuzhou, China, 350014
      • Guangzhou, China, 510080
      • Hangzhou, China, 310016
      • Nanjing, China, 210002
      • Shanghai, China, 200032
      • Shanghai, China, 200433
      • Shanghai, China, 200030
      • Shantou, China, 515041
      • Wuhan, China, 430023
      • Xi'an, China, 710061
  • Filipinas
      • Davao, Filipinas, 8000
      • Desmarinas City, Filipinas, 4114
      • Manila, Filipinas, 1000
      • Quezon City, Filipinas, 1104
      • San Juan, Filipinas, 1500
  • Malásia
      • Kelantan, Malásia, 16150
      • Kuala Lumpur, Malásia, 59100
      • Kuala Lumpur, Malásia, 50603
      • Nilai, Malásia, 71800
      • Pahang, Malásia, 25100
      • Petaling Jaya, Malásia, 46150
      • Petaling Jaya, Selangor, Malásia, 46050
      • Pulau Pinang, Malásia, 11600

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 e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Adult participants, ≥ 18 years of age.
  • Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
  • Presence of epidermal growth factor receptor (EGFR) mutations in tumours.
  • Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.
  • European Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria:

  • Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).
  • Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.
  • Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease.
  • Any inflammatory changes of the surface of the eye.
  • ≥ Grade 2 peripheral neuropathy.
  • History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
  • Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months.
  • Human immunodeficiency virus (HIV) infection.
  • Pregnant, nursing, or lactating women.

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: Erlotinib
Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
Medicamento: Erlotinib
Erlotinib was supplied as tablets.
Outros nomes:
  • Tarceva
Comparador Ativo: Chemotherapy
Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
Medicamento: Chemotherapy
Cisplatin and gemcitabine were locally sourced with commercial products.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Investigator-assessed Duration of Progression-free Survival
Prazo: Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)
The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first. PD was defined as: (1) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (2) An unequivocal progression of existing non-target lesions. When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy. When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease. (3) The appearance of new malignant lesions.
Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Responders as Assessed by the Investigator
Prazo: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
A responder was defined as a participant with either a complete response (CR) or a partial response (PR), as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A CR was defined as: (1) The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to < 10 mm. (2) The disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be non-pathological in size (< 10 mm in the short axis). A PR was defined as: (1) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. (2) The persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits.
Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
Percentage of Participants With Disease Control
Prazo: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD.
Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
Duration of Response
Prazo: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.
Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
Overall Survival
Prazo: Baseline to the end of the study (3 years, 1 month)
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Baseline to the end of the study (3 years, 1 month)
Safety: Incidence of Adverse Events
Prazo: 36 months
36 months
Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire
Prazo: approximately 21 months
approximately 21 months

Colaboradores e Investigadores

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

Patrocinador

Hoffmann-La Roche

Publicações e links úteis

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Publicações Gerais

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

1 de março de 2011

Conclusão Primária (Real)

1 de julho de 2012

Conclusão do estudo (Real)

1 de abril de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

26 de abril de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de abril de 2011

Primeira postagem (Estimativa)

27 de abril de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

24 de fevereiro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de fevereiro de 2015

Última verificação

1 de fevereiro de 2015

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • YO25121

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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