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)

  • Non-Small Cell Lung Cancer
Trial Status:

Completed

This trial runs in
Countries
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • France
  • Germany
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • Portugal
  • Russia
  • Singapore
  • Slovakia
  • Spain
  • Switzerland
  • Taiwan
  • Ukraine
  • United States
Trial Identifier:

NCT02366143 2014-003207-30 GO29436

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      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 Sponsor
      Phase 3 Phase
      NCT02366143 , GO29436 , 2014-003207-30 Trial Identifier
      Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Bevacizumab, Carboplatin, Paclitaxel Treatments
      Carcinoma, Non-Small-Cell Lung Condition
      Official Title

      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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • 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
      Exclusion Criteria

      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

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