A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

  • Cancer
  • Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Countries
  • Belgium
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Spain
  • United States
Study Identifier:

NCT02367781 2014-003206-32 GO29537

      Show study locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study Summary

      This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT02367781, GO29537, 2014-003206-32 Study Identifier
      Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody, Carboplatin, Nab-Paclitaxel, Pemetrexed Treatments
      Carcinoma, Non-Squamous Non-Small Cell Lung Condition
      Official Title

      A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive 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 of 0 or 1
      • Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
      • Participants with no prior treatment for Stage IV non-squamous NSCLC
      • Previously obtained archival tumor tissue or tissue obtained from fresh 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

      For the latest version of this information please go to www.forpatients.roche.com

       

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