A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

  • Câncer
  • Câncer de Pulmão
  • Câncer Pulmonar de Células Não Pequenas
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Status do estudo:

Concluído

Este estudo é realizado em
Cidades
  • Londrina
  • Minas Gerais
  • Rio Grande do Norte
  • Rio Grande do Sul
  • São Paulo
Identificador de estudo:

NCT02366143 2014-003207-30 GO29436

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      A seguinte informação vem do site ClinicalTrials.gov publicamente disponível e foi editada para leigos.

      As informações abaixo se origina a partir do site ClinicalTrials.gov publicamente disponível e não foi modificado.

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      Resumo do Estudo

      This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).

      Hoffmann-La Roche Patrocinador
      Phase 3 Fase
      NCT02366143, GO29436, 2014-003207-30 Identificador de estudo
      Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Bevacizumab, Carboplatin, Paclitaxel Tratamento
      Carcinoma, Non-Small-Cell Lung Condição
      Título

      A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

      Critérios de elegibilidade

      Todos Gênero
      ≥18 Anos Idade
      Não Voluntários Saudáveis
      Critérios de Inclusão
      • Eastern Cooperative Oncology Group performance status 0 or 1
      • Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
      • Participants with no prior treatment for Stage IV non-squamous NSCLC
      • Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
      • Measurable disease as defined by RECIST v1.1
      • Adequate hematologic and end organ function
      Critérios de Exclusão

      Cancer-Specific Exclusions:

      • Active or untreated central nervous system metastases
      • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome

      General Medical Exclusions:

      • Pregnant or lactating women
      • History of autoimmune disease
      • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
      • Positive test for human immunodeficiency virus
      • Active hepatitis B or hepatitis C
      • Severe infection within 4 weeks prior to randomization
      • Significant cardiovascular disease
      • Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures

      Exclusion Criteria Related to Medications:

      • Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies

      Sobre Ensaios Clínicos

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